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Radiation Therapy With or Without Combination Chemotherapy or Pazopanib Before Surgery in Treating Patients With Newly Diagnosed Non-rhabdomyosarcoma Soft Tissue Sarcomas That Can Be Removed by Surgery

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ClinicalTrials.gov Identifier: NCT02180867
Recruitment Status : Active, not recruiting
First Posted : July 3, 2014
Results First Posted : October 9, 2020
Last Update Posted : October 4, 2021
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Alveolar Soft Part Sarcoma
Angiomatoid Fibrous Histiocytoma
Atypical Fibroxanthoma
Clear Cell Sarcoma of Soft Tissue
Epithelioid Malignant Peripheral Nerve Sheath Tumor
Epithelioid Sarcoma
Extraskeletal Myxoid Chondrosarcoma
Extraskeletal Osteosarcoma
Fibrohistiocytic Neoplasm
Fibrosarcoma
Inflammatory Myofibroblastic Tumor
Intimal Sarcoma
Leiomyosarcoma
Liposarcoma
Liver Embryonal Sarcoma
Low Grade Fibromyxoid Sarcoma
Low Grade Myofibroblastic Sarcoma
Malignant Cutaneous Granular Cell Tumor
Malignant Peripheral Nerve Sheath Tumor
Malignant Triton Tumor
Mesenchymal Chondrosarcoma
Myxofibrosarcoma
Myxoid Chondrosarcoma
Myxoinflammatory Fibroblastic Sarcoma
Nerve Sheath Neoplasm
PEComa
Pericytic Neoplasm
Plexiform Fibrohistiocytic Tumor
Sclerosing Epithelioid Fibrosarcoma
Skin Glomus Tumor
Stage IB Soft Tissue Sarcoma AJCC v7
Stage IIB Soft Tissue Sarcoma AJCC v7
Stage III Soft Tissue Sarcoma AJCC v7
Stage IV Soft Tissue Sarcoma AJCC v7
Synovial Sarcoma
Undifferentiated High Grade Pleomorphic Sarcoma of Bone
Interventions Drug: Doxorubicin
Drug: Doxorubicin Hydrochloride
Drug: Ifosfamide
Drug: Pazopanib
Drug: Pazopanib Hydrochloride
Radiation: Radiation Therapy
Procedure: Therapeutic Conventional Surgery
Enrollment 140
Recruitment Details  
Pre-assignment Details All patients began at Dose-Finding Level 1. Dose-Finding Level 0 CR, Dose-Finding Level 2 CR, and Dose-Finding Level 0 RT never enrolled because protocol-defined dose de-escalation and escalation parameters were not met. Cohorts C and D were closed to further patient accrual on October 12, 2017 due to slower than anticipated enrollment.
Arm/Group Title Dose-Finding Level 1 CR Dose-Finding Level 1 RT Dose-Finding Level 2 RT Regimen A Regimen B Regimen C Regimen D
Hide Arm/Group Description

Dose-Finding Level 1 CR:

Adult: Pazopanib 600 mg; Pediatric: Pazopanib 350 mg/m2

Dose-Finding Level 1 RT:

Adult: Pazopanib 600 mg; Pediatric: Pazopanib 350 mg/m2

Dose-Finding Level 2 RT:

Adult: Pazopanib 800 mg; Pediatric: Pazopanib 450 mg/m2

Regimen A: Chemoradiation plus pazopanib Regimen B: Chemoradiation alone Regimen C: Radiation therapy plus pazopanib Regimen D: Radiation therapy alone
Period Title: Overall Study
Started 10 11 10 49 48 6 6
Pediatric Patients 6 4 3 18 19 1 0
Adult Patients 4 7 7 31 29 5 6
Completed 4 0 6 23 21 3 1
Not Completed 6 11 4 26 27 3 5
Reason Not Completed
Adverse Event             3             4             1             5             0             0             0
Death             0             0             0             0             1             0             0
Lack of Efficacy             0             2             0             1             6             0             1
Physician Decision             1             3             1             10             9             3             4
Withdrawal by Subject             0             0             0             1             1             0             0
Ineligible             1             2             0             3             5             0             0
Repeat Eligibility Studies             0             0             0             0             1             0             0
Refusal of further protocol therapy             1             0             2             6             4             0             0
Arm/Group Title Dose-Finding Level 1 CR Dose-Finding Level 1 RT Dose-Finding Level 2 RT Regimen A Regimen B Regimen C Regimen D Total
Hide Arm/Group Description

Dose-Finding Level 1 CR:

Adult: Pazopanib 600 mg; Pediatric: Pazopanib 350 mg/m2

Dose-Finding Level 1 RT:

Adult: Pazopanib 600 mg; Pediatric: Pazopanib 350 mg/m2

Dose-Finding Level 2 RT:

Adult: Pazopanib 800 mg; Pediatric: Pazopanib 450 mg/m2

Regimen A: Chemoradiation plus pazopanib Regimen B: Chemoradiation alone Regimen C: Radiation therapy plus pazopanib Regimen D: Radiation therapy alone Total of all reporting groups
Overall Number of Baseline Participants 10 11 10 49 48 6 6 140
Hide Baseline Analysis Population Description
It was pre-specified to combine adult and pediatric participants for analysis as they received an equivalent dose of Pazopanib. There were no patients enrolled onto Dose-Finding Level 0 CR and Dose-Finding Level 2 CR or Dose-Finding Level 0 RT.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 10 participants 11 participants 10 participants 49 participants 48 participants 6 participants 6 participants 140 participants
225.1  (57.8) 524.3  (270.3) 407.3  (224.7) 376.3  (243.4) 356.2  (221.8) 547.2  (260.6) 722.8  (141.9) 394.6  (242.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 11 participants 10 participants 49 participants 48 participants 6 participants 6 participants 140 participants
Female
4
  40.0%
3
  27.3%
3
  30.0%
30
  61.2%
18
  37.5%
2
  33.3%
3
  50.0%
63
  45.0%
Male
6
  60.0%
8
  72.7%
7
  70.0%
19
  38.8%
30
  62.5%
4
  66.7%
3
  50.0%
77
  55.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 11 participants 10 participants 49 participants 48 participants 6 participants 6 participants 140 participants
Hispanic or Latino
2
  20.0%
1
   9.1%
1
  10.0%
13
  26.5%
9
  18.8%
0
   0.0%
0
   0.0%
26
  18.6%
Not Hispanic or Latino
6
  60.0%
9
  81.8%
9
  90.0%
34
  69.4%
38
  79.2%
6
 100.0%
6
 100.0%
108
  77.1%
Unknown or Not Reported
2
  20.0%
1
   9.1%
0
   0.0%
2
   4.1%
1
   2.1%
0
   0.0%
0
   0.0%
6
   4.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 11 participants 10 participants 49 participants 48 participants 6 participants 6 participants 140 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   2.1%
0
   0.0%
0
   0.0%
1
   0.7%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
2
  20.0%
2
  18.2%
1
  10.0%
3
   6.1%
6
  12.5%
1
  16.7%
0
   0.0%
15
  10.7%
White
7
  70.0%
8
  72.7%
8
  80.0%
39
  79.6%
38
  79.2%
5
  83.3%
5
  83.3%
110
  78.6%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
1
  10.0%
1
   9.1%
1
  10.0%
7
  14.3%
3
   6.3%
0
   0.0%
1
  16.7%
14
  10.0%
1.Primary Outcome
Title Feasible Dose: Pediatric
Hide Description The dose of pazopanib that is feasible when given in combination with radiation or chemoradiation in pediatric unresected intermediate- and high-risk NRSTS patients. Initially, up to 10 patients (minimum of 3 patients ≥ 2 and < 18 years of age and 3 patients ≥ 18 years of age) eligible for each of the two study cohorts were non-randomly assigned (to generate 8 patients evaluable for toxicity) to receive treatment with pazopanib at dose level 1. A protocol-defined list of pazopanib-associated adverse events were defined as dose-limiting toxicities. The pazopanib dose determined to be feasible was based on the number of patient-reported dose-limiting toxicities encountered.
Time Frame After the first 6 weeks of Induction
Hide Outcome Measure Data
Hide Analysis Population Description
Pediatric patients, excluding 1 ineligible patient in Dose-Finding CR group and 1 ineligible patient in Dose-Finding RT group
Arm/Group Title All Pediatric Dose Finding CR Cohorts All Pediatric Dose Finding RT Cohorts
Hide Arm/Group Description:
Dose-Finding CR: Chemoradiation plus pazopanib
Dose-Finding RT: Radiation therapy plus pazopanib
Overall Number of Participants Analyzed 5 6
Measure Type: Number
Unit of Measure: milligram per square meter
350 450
2.Primary Outcome
Title Feasible Dose: Adult
Hide Description The dose of pazopanib that is feasible when given in combination with radiation or chemoradiation in adult unresected intermediate- and high-risk NRSTS patients. Initially, up to 10 patients (minimum of 3 patients ≥ 2 and < 18 years of age and 3 patients ≥ 18 years of age) eligible for each of the two study cohorts were non-randomly assigned (to generate 8 patients evaluable for toxicity) to receive treatment with pazopanib at dose level 1. A protocol-defined list of pazopanib-associated adverse events were defined as dose-limiting toxicities. The pazopanib dose determined to be feasible was based on the number of patient-reported dose-limiting toxicities encountered.
Time Frame After the first 6 weeks of Induction
Hide Outcome Measure Data
Hide Analysis Population Description
Adult patients, excluding 1 ineligible patient in Dose-Finding RT group
Arm/Group Title All Adult Dose Finding CR Cohorts All Adult Dose Finding RT Cohorts
Hide Arm/Group Description:
Dose-Finding CR: Chemoradiation plus pazopanib
Dose-Finding RT: Radiation therapy plus pazopanib
Overall Number of Participants Analyzed 4 13
Measure Type: Number
Unit of Measure: milligram
600 800
3.Primary Outcome
Title Percentage of Chemoradiotherapy Patients With Positive Pathologic Response at Week 13
Hide Description A responder is defined by more than (90% tumor necrosis at week 13). A non-responder has less than 90% necrosis or progressive disease before week 13.
Time Frame Week 13 after induction
Hide Outcome Measure Data
Hide Analysis Population Description
It was pre-specified to combine adult and pediatric participants for analysis as they received an equivalent dose of Pazopanib. There were no patients enrolled onto Dose-Finding Level 0 CR or Dose-Finding Level 2 CR. 19 Regimen A patients and 23 Regimen B patients were excluded.
Arm/Group Title Dose-Finding Level 1 CR Regimen A Regimen B
Hide Arm/Group Description:

Dose-Finding Level 1 CR:

Adult: Pazopanib 600 mg; Pediatric: Pazopanib 350 mg/m2

Regimen A: Chemoradiation plus pazopanib
Regimen B: Chemoradiation alone
Overall Number of Participants Analyzed 6 30 25
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of patients
66.67
(28.95 to 100)
46.67
(28.81 to 64.52)
24
(7.26 to 40.74)
4.Primary Outcome
Title Percentage of Radiotherapy Patients With Positive Pathologic Response at Week 10
Hide Description A responder is defined by more than 90% tumor necrosis at week 10. A non-responder has less than 90% necrosis or progressive disease before week 10.
Time Frame Week 10 after induction
Hide Outcome Measure Data
Hide Analysis Population Description
It was pre-specified to combine adult and pediatric participants for analysis as they received an equivalent dose of Pazopanib. There were no patients enrolled onto Dose Level 0 RT. 3 Regimen C patients excluded: 1 patient did not receive treatment and 2 missing review; 4 Regimen D patients excluded due to missing review.
Arm/Group Title Dose-Finding Level 1 RT Dose-Finding Level 2 RT Regimen C Regimen D
Hide Arm/Group Description:

Dose-Finding Level 1 RT:

Adult: Pazopanib 600 mg; Pediatric: Pazopanib 350 mg/m2

Dose-Finding Level 2 RT:

Adult: Pazopanib 800 mg; Pediatric: Pazopanib 450 mg/m2

Regimen C: Radiation therapy plus pazopanib
Regimen D: Radiation therapy alone
Overall Number of Participants Analyzed 3 5 3 2
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of patients
0
(0 to 0)
40
(0 to 82.94)
0
(0 to 0)
0
(0 to 0)
5.Primary Outcome
Title Percentage of Radiotherapy Patients Failure Free at 5 Years Following Study Entry
Hide Description Time to the first occurrence of relapse, progression, secondary cancer or death from any cause.
Time Frame From enrollment to up to 60 months
Hide Outcome Measure Data
Hide Analysis Population Description
Data for the phase III portion of the study were never collected because the RT arm was closed earlier due to slow accrual.
Arm/Group Title Regimen C Regimen D
Hide Arm/Group Description:
Regimen C: Radiation therapy plus pazopanib
Regimen D: Radiation therapy alone
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Percentage of Patients Local Failure Free at 5 Years Following Study Entry
Hide Description Defined as disease recurrence only at the primary site of disease at diagnosis. The relative risk of specific failure types will be estimated and compared descriptively using the Cox proportional hazard model.
Time Frame From enrollment to up to 60 months
Outcome Measure Data Not Reported
7.Secondary Outcome
Title Percentage of Patients Regional Failure Free at 5 Years Following Study Entry
Hide Description Defined as disease recurrence at lymph nodes regional to the primary disease site, with or without local failure but without distant failure. The relative risk of specific failure types will be estimated and compared descriptively using the Cox proportional hazard model.
Time Frame From enrollment to up to 60 months
Outcome Measure Data Not Reported
8.Secondary Outcome
Title Percentage of Patients Distant Failure Free at 5 Years Following Study Entry
Hide Description Defined as disease recurrence at sites other than the primary site and diagnosis and nodes regional to that site (metastatic disease, whether or not present at diagnosis), with or without loco-regional failure. The relative risk of specific failure types will be estimated and compared descriptively using the Cox proportional hazard model.
Time Frame From enrollment to up to 60 months
Outcome Measure Data Not Reported
9.Secondary Outcome
Title Percentage of Patients Who Experienced Grade 3 or Higher Toxicity Assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE)
Hide Description Participants who experienced Grade 3 or higher toxicity was assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE).
Time Frame Reporting of adverse events was required from the start of protocol therapy and until 30 days from the last administration of study drugs; up to 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Ineligible patients are excluded.
Arm/Group Title Dose-Finding Level 1 CR Dose-Finding Level 1 RT Dose-Finding Level 2 RT Regimen A Regimen B Regimen C Regimen D
Hide Arm/Group Description:

Dose-Finding Level 1 CR:

Adult: Pazopanib 600 mg; Pediatric: Pazopanib 350 mg/m2

Dose-Finding Level 1 RT:

Adult: Pazopanib 600 mg; Pediatric: Pazopanib 350 mg/m2

Dose-Finding Level 2 RT:

Adult: Pazopanib 800 mg; Pediatric:

Pazopanib 450 mg/m2

Regimen A: Chemoradiation plus pazopanib
Regimen B: Chemoradiation alone
Regimen C: Radiation therapy plus pazopanib
Regimen D: Radiation therapy alone
Overall Number of Participants Analyzed 9 9 10 46 43 6 6
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of patients
Pediatric Patients Number Analyzed 5 participants 3 participants 3 participants 16 participants 18 participants 1 participants 0 participants
60
(17.06 to 100)
66.67
(13.32 to 100)
33.33
(0 to 86.68)
75
(53.78 to 96.22)
33.33
(11.56 to 55.11)
0
(0 to 0)
Adult Patients Number Analyzed 4 participants 6 participants 7 participants 30 participants 25 participants 5 participants 6 participants
75
(32.56 to 100)
66.67
(28.95 to 100)
57.14
(20.48 to 93.80)
86.67
(74.50 to 98.83)
36
(17.18 to 54.82)
40
(0 to 82.94)
0
(0 to 0)
10.Other Pre-specified Outcome
Title Relative Frequency of Actionable Mutations
Hide Description Descriptive statistical analyses will be provided to estimate the relative frequency of actionable mutations across the whole cohort and within more common histological subtypes, like synovial sarcoma and malignant peripheral nerve sheath tumors.
Time Frame At diagnosis
Outcome Measure Data Not Reported
11.Other Pre-specified Outcome
Title Prevalence of Circulating Tumor DNA (ctDNA)
Hide Description Descriptive analyses will be performed to summarize the prevalence of ctDNA.
Time Frame At diagnosis
Outcome Measure Data Not Reported
12.Other Pre-specified Outcome
Title Mean Pharmacokinetic Parameters of Doxorubicin and Pazopanib
Hide Description Pharmacokinetic parameters such as the clearance of doxorubicin and pazopanib will be estimated.
Time Frame Up to 48 hours after the end of infusion
Outcome Measure Data Not Reported
13.Other Pre-specified Outcome
Title Change in Fludeoxyglucose F 18 (FDG) Positron Emission Tomography (PET) Maximum Standard Uptake Value (SUVmax)
Hide Description To evaluate change in FDG PET maximum standard uptake value (SUVmax) from baseline to Week 10 or 13 in patients with unresected tumors and to correlate this change with pathologic response and EFS.
Time Frame From enrollment to week 10 or 13 prior to tumor resection
Outcome Measure Data Not Reported
14.Other Pre-specified Outcome
Title Relative Risk of Failure Based on Both Standard Imaging and Pathologic Assessment
Hide Description To compare the rate of response by standard imaging and pathologic assessment to determine which correlates better with local tumor control, distant tumor control, event free survival, and overall survival.
Time Frame From enrollment up to 60 months
Outcome Measure Data Not Reported
Time Frame Reporting of adverse events was required from the start of protocol therapy and until 30 days from the last administration of study drugs; up to 1 year
Adverse Event Reporting Description Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
 
Arm/Group Title Dose-Finding Level 1 CR Dose-Finding Level 1 RT Dose-Finding Level 2 RT Regimen A Regimen B Regimen C Regimen D
Hide Arm/Group Description

Dose-Finding Level 1 CR:

Adult: Pazopanib 600 mg; Pediatric: Pazopanib 350 mg/m2

Dose-Finding Level 1 RT:

Adult: Pazopanib 600 mg; Pediatric: Pazopanib 350 mg/m2

Dose-Finding Level 2 RT:

Adult: Pazopanib 800 mg; Pediatric: Pazopanib 450 mg/m2

Regimen A: Chemoradiation plus pazopanib Regimen B: Chemoradiation alone Regimen C: Radiation therapy plus pazopanib Regimen D: Radiation therapy alone
All-Cause Mortality
Dose-Finding Level 1 CR Dose-Finding Level 1 RT Dose-Finding Level 2 RT Regimen A Regimen B Regimen C Regimen D
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/9 (11.11%)   4/9 (44.44%)   3/10 (30.00%)   5/46 (10.87%)   9/43 (20.93%)   0/6 (0.00%)   2/6 (33.33%) 
Hide Serious Adverse Events
Dose-Finding Level 1 CR Dose-Finding Level 1 RT Dose-Finding Level 2 RT Regimen A Regimen B Regimen C Regimen D
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   6/9 (66.67%)   6/9 (66.67%)   2/10 (20.00%)   33/46 (71.74%)   8/43 (18.60%)   1/6 (16.67%)   0/6 (0.00%) 
Blood and lymphatic system disorders               
Febrile neutropenia  1 [1]  1/5 (20.00%)  0/3 (0.00%)  0/3 (0.00%)  7/16 (43.75%)  0/18 (0.00%)  0/1 (0.00%)  0/0 
Anemia  1 [2]  0/4 (0.00%)  1/6 (16.67%)  0/7 (0.00%)  2/30 (6.67%)  1/25 (4.00%)  0/5 (0.00%)  0/6 (0.00%) 
Blood and lymphatic system disorders - Other, specify  1 [2]  0/4 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  1/30 (3.33%)  0/25 (0.00%)  0/5 (0.00%)  0/6 (0.00%) 
Febrile neutropenia  1 [2]  1/4 (25.00%)  0/6 (0.00%)  0/7 (0.00%)  11/30 (36.67%)  1/25 (4.00%)  0/5 (0.00%)  0/6 (0.00%) 
Cardiac disorders               
Atrial fibrillation  1 [2]  0/4 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  1/30 (3.33%)  0/25 (0.00%)  0/5 (0.00%)  0/6 (0.00%) 
Atrial flutter  1 [2]  0/4 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  1/30 (3.33%)  0/25 (0.00%)  0/5 (0.00%)  0/6 (0.00%) 
Sinus tachycardia  1 [2]  0/4 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  1/30 (3.33%)  0/25 (0.00%)  0/5 (0.00%)  0/6 (0.00%) 
Eye disorders               
Blurred vision  1 [2]  0/4 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  1/30 (3.33%)  0/25 (0.00%)  0/5 (0.00%)  0/6 (0.00%) 
Photophobia  1 [2]  0/4 (0.00%)  0/6 (0.00%)  1/7 (14.29%)  0/30 (0.00%)  0/25 (0.00%)  0/5 (0.00%)  0/6 (0.00%) 
Gastrointestinal disorders               
Diarrhea  1 [1]  0/5 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/16 (0.00%)  0/18 (0.00%)  0/1 (0.00%)  0/0 
Ileus  1 [1]  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/16 (6.25%)  0/18 (0.00%)  0/1 (0.00%)  0/0 
Mucositis oral  1 [1]  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  3/16 (18.75%)  0/18 (0.00%)  0/1 (0.00%)  0/0 
Vomiting  1 [1]  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  2/16 (12.50%)  0/18 (0.00%)  0/1 (0.00%)  0/0 
Diarrhea  1 [2]  0/4 (0.00%)  0/6 (0.00%)  1/7 (14.29%)  1/30 (3.33%)  0/25 (0.00%)  0/5 (0.00%)  0/6 (0.00%) 
Esophagitis  1 [2]  0/4 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  1/30 (3.33%)  0/25 (0.00%)  0/5 (0.00%)  0/6 (0.00%) 
Mucositis oral  1 [2]  0/4 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  1/30 (3.33%)  0/25 (0.00%)  0/5 (0.00%)  0/6 (0.00%) 
Nausea  1 [2]  1/4 (25.00%)  0/6 (0.00%)  0/7 (0.00%)  1/30 (3.33%)  0/25 (0.00%)  1/5 (20.00%)  0/6 (0.00%) 
Vomiting  1 [2]  1/4 (25.00%)  0/6 (0.00%)  1/7 (14.29%)  2/30 (6.67%)  0/25 (0.00%)  0/5 (0.00%)  0/6 (0.00%) 
General disorders               
Fever  1 [1]  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/16 (6.25%)  0/18 (0.00%)  0/1 (0.00%)  0/0 
Pain  1 [1]  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/16 (6.25%)  0/18 (0.00%)  0/1 (0.00%)  0/0 
Chills  1 [2]  0/4 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  1/30 (3.33%)  0/25 (0.00%)  1/5 (20.00%)  0/6 (0.00%) 
Death NOS  1 [2]  0/4 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/30 (0.00%)  1/25 (4.00%)  0/5 (0.00%)  0/6 (0.00%) 
Fatigue  1 [2]  0/4 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  2/30 (6.67%)  0/25 (0.00%)  1/5 (20.00%)  0/6 (0.00%) 
Fever  1 [2]  0/4 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  2/30 (6.67%)  2/25 (8.00%)  1/5 (20.00%)  0/6 (0.00%) 
Gait disturbance  1 [2]  0/4 (0.00%)  1/6 (16.67%)  0/7 (0.00%)  0/30 (0.00%)  0/25 (0.00%)  0/5 (0.00%)  0/6 (0.00%) 
General disorders and administration site conditions - Other, specify  1 [2]  0/4 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  1/30 (3.33%)  0/25 (0.00%)  0/5 (0.00%)  0/6 (0.00%) 
Multi-organ failure  1 [2]  0/4 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/30 (0.00%)  1/25 (4.00%)  0/5 (0.00%)  0/6 (0.00%) 
Non-cardiac chest pain  1 [2]  0/4 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  1/30 (3.33%)  0/25 (0.00%)  0/5 (0.00%)  0/6 (0.00%) 
Hepatobiliary disorders               
Perforation bile duct  1 [1]  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/16 (6.25%)  0/18 (0.00%)  0/1 (0.00%)  0/0 
Infections and infestations               
Sepsis  1 [1]  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/16 (0.00%)  1/18 (5.56%)  0/1 (0.00%)  0/0 
Skin infection  1 [1]  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/16 (6.25%)  0/18 (0.00%)  0/1 (0.00%)  0/0 
Wound infection  1 [1]  0/5 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  1/16 (6.25%)  0/18 (0.00%)  0/1 (0.00%)  0/0 
Sepsis  1 [2]  0/4 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  4/30 (13.33%)  1/25 (4.00%)  0/5 (0.00%)  0/6 (0.00%) 
Skin infection  1 [2]  0/4 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  2/30 (6.67%)  1/25 (4.00%)  0/5 (0.00%)  0/6 (0.00%) 
Upper respiratory infection  1 [2]  0/4 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/30 (0.00%)  1/25 (4.00%)  0/5 (0.00%)  0/6 (0.00%) 
Urinary tract infection  1 [2]  0/4 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  1/30 (3.33%)  0/25 (0.00%)  0/5 (0.00%)  0/6 (0.00%) 
Wound infection  1 [2]  1/4 (25.00%)  3/6 (50.00%)  1/7 (14.29%)  1/30 (3.33%)  1/25 (4.00%)  0/5 (0.00%)  0/6 (0.00%) 
Lung infection  1 [2]  0/4 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/30 (0.00%)  1/25 (4.00%)  0/5 (0.00%)  0/6 (0.00%) 
Soft tissue infection  1 [2]  0/4 (0.00%)  1/6 (16.67%)  0/7 (0.00%)  0/30 (0.00%)  0/25 (0.00%)  0/5 (0.00%)  0/6 (0.00%) 
Device related infection  1 [2]  0/4 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  1/30 (3.33%)  1/25 (4.00%)  0/5 (0.00%)  0/6 (0.00%) 
Injury, poisoning and procedural complications               
Wound dehiscence  1 [1]  0/5 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  1/16 (6.25%)  1/18 (5.56%)  0/1 (0.00%)  0/0 
Wound complication  1 [1]  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/16 (6.25%)  0/18 (0.00%)  0/1 (0.00%)  0/0 
Wound dehiscence  1 [2]  2/4 (50.00%)  0/6 (0.00%)  0/7 (0.00%)  4/30 (13.33%)  0/25 (0.00%)  0/5 (0.00%)  0/6 (0.00%) 
Wound complication  1 [2]  0/4 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  2/30 (6.67%)  1/25 (4.00%)  0/5 (0.00%)  0/6 (0.00%) 
Postoperative hemorrhage  1 [2]  0/4 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  1/30 (3.33%)  0/25 (0.00%)  0/5 (0.00%)  0/6 (0.00%) 
Dermatitis radiation  1 [2]  0/4 (0.00%)  0/6 (0.00%)  1/7 (14.29%)  1/30 (3.33%)  0/25 (0.00%)  0/5 (0.00%)  0/6 (0.00%) 
Investigations               
Creatinine increased  1 [1]  0/5 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/16 (0.00%)  0/18 (0.00%)  0/1 (0.00%)  0/0 
Alanine aminotransferase increased  1 [2]  0/4 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  1/30 (3.33%)  0/25 (0.00%)  0/5 (0.00%)  0/6 (0.00%) 
Blood bilirubin increased  1 [2]  0/4 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  1/30 (3.33%)  0/25 (0.00%)  0/5 (0.00%)  0/6 (0.00%) 
Electrocardiogram QT corrected interval prolonged  1 [2]  0/4 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  1/30 (3.33%)  0/25 (0.00%)  0/5 (0.00%)  0/6 (0.00%) 
Lymphocyte count decreased  1 [2]  0/4 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  2/30 (6.67%)  1/25 (4.00%)  0/5 (0.00%)  0/6 (0.00%) 
Neutrophil count decreased  1 [2]  0/4 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  5/30 (16.67%)  0/25 (0.00%)  0/5 (0.00%)  0/6 (0.00%) 
Platelet count decreased  1 [2]  0/4 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  5/30 (16.67%)  0/25 (0.00%)  0/5 (0.00%)  0/6 (0.00%) 
White blood cell decreased  1 [2]  0/4 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  8/30 (26.67%)  0/25 (0.00%)  0/5 (0.00%)  0/6 (0.00%) 
Ejection fraction decreased  1 [2]  0/4 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  1/30 (3.33%)  0/25 (0.00%)  0/5 (0.00%)  0/6 (0.00%) 
Metabolism and nutrition disorders               
Anorexia  1 [1]  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  2/16 (12.50%)  0/18 (0.00%)  0/1 (0.00%)  0/0 
Dehydration  1 [1]  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  2/16 (12.50%)  0/18 (0.00%)  0/1 (0.00%)  0/0 
Hyperkalemia  1 [1]  0/5 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/16 (0.00%)  0/18 (0.00%)  0/1 (0.00%)  0/0 
Dehydration  1 [2]  1/4 (25.00%)  0/6 (0.00%)  1/7 (14.29%)  0/30 (0.00%)  0/25 (0.00%)  0/5 (0.00%)  0/6 (0.00%) 
Hyperglycemia  1 [2]  0/4 (0.00%)  1/6 (16.67%)  0/7 (0.00%)  0/30 (0.00%)  1/25 (4.00%)  0/5 (0.00%)  0/6 (0.00%) 
Hypokalemia  1 [2]  0/4 (0.00%)  1/6 (16.67%)  0/7 (0.00%)  2/30 (6.67%)  0/25 (0.00%)  0/5 (0.00%)  0/6 (0.00%) 
Hyponatremia  1 [2]  0/4 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  3/30 (10.00%)  1/25 (4.00%)  1/5 (20.00%)  0/6 (0.00%) 
Hypophosphatemia  1 [2]  0/4 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  3/30 (10.00%)  0/25 (0.00%)  1/5 (20.00%)  0/6 (0.00%) 
Musculoskeletal and connective tissue disorders               
Pain in extremity  1 [1]  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/16 (6.25%)  0/18 (0.00%)  0/1 (0.00%)  0/0 
Pain in extremity  1 [2]  0/4 (0.00%)  1/6 (16.67%)  0/7 (0.00%)  1/30 (3.33%)  0/25 (0.00%)  0/5 (0.00%)  0/6 (0.00%) 
Nervous system disorders               
Cognitive disturbance  1 [2]  0/4 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  1/30 (3.33%)  0/25 (0.00%)  0/5 (0.00%)  0/6 (0.00%) 
Dizziness  1 [2]  0/4 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  1/30 (3.33%)  0/25 (0.00%)  0/5 (0.00%)  0/6 (0.00%) 
Encephalopathy  1 [2]  0/4 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  1/30 (3.33%)  0/25 (0.00%)  0/5 (0.00%)  0/6 (0.00%) 
Headache  1 [2]  0/4 (0.00%)  0/6 (0.00%)  1/7 (14.29%)  0/30 (0.00%)  0/25 (0.00%)  0/5 (0.00%)  0/6 (0.00%) 
Stroke  1 [2]  0/4 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  1/30 (3.33%)  0/25 (0.00%)  0/5 (0.00%)  0/6 (0.00%) 
Syncope  1 [2]  1/4 (25.00%)  0/6 (0.00%)  0/7 (0.00%)  0/30 (0.00%)  0/25 (0.00%)  0/5 (0.00%)  0/6 (0.00%) 
Psychiatric disorders               
Hallucinations  1 [1]  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/16 (6.25%)  0/18 (0.00%)  0/1 (0.00%)  0/0 
Delirium  1 [2]  0/4 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  3/30 (10.00%)  0/25 (0.00%)  0/5 (0.00%)  0/6 (0.00%) 
Depression  1 [2]  0/4 (0.00%)  0/6 (0.00%)  1/7 (14.29%)  1/30 (3.33%)  0/25 (0.00%)  0/5 (0.00%)  0/6 (0.00%) 
Renal and urinary disorders               
Acute kidney injury  1 [1]  0/5 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/16 (0.00%)  0/18 (0.00%)  0/1 (0.00%)  0/0 
Renal and urinary disorders - Other, specify  1 [2]  0/4 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/30 (0.00%)  1/25 (4.00%)  0/5 (0.00%)  0/6 (0.00%) 
Reproductive system and breast disorders               
Uterine hemorrhage  1 [2]  0/4 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  1/30 (3.33%)  0/25 (0.00%)  0/5 (0.00%)  0/6 (0.00%) 
Respiratory, thoracic and mediastinal disorders               
Hypoxia  1 [1]  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/16 (6.25%)  0/18 (0.00%)  0/1 (0.00%)  0/0 
Dyspnea  1 [2]  0/4 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  1/30 (3.33%)  1/25 (4.00%)  0/5 (0.00%)  0/6 (0.00%) 
Hypoxia  1 [2]  0/4 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  1/30 (3.33%)  0/25 (0.00%)  0/5 (0.00%)  0/6 (0.00%) 
Laryngospasm  1 [2]  0/4 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  1/30 (3.33%)  0/25 (0.00%)  0/5 (0.00%)  0/6 (0.00%) 
Pleural effusion  1 [2]  0/4 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/30 (0.00%)  1/25 (4.00%)  0/5 (0.00%)  0/6 (0.00%) 
Pneumothorax  1 [2]  0/4 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  1/30 (3.33%)  0/25 (0.00%)  0/5 (0.00%)  0/6 (0.00%) 
Pulmonary edema  1 [2]  0/4 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  2/30 (6.67%)  0/25 (0.00%)  0/5 (0.00%)  0/6 (0.00%) 
Skin and subcutaneous tissue disorders               
Skin hypopigmentation  1 [2]  0/4 (0.00%)  0/6 (0.00%)  1/7 (14.29%)  0/30 (0.00%)  0/25 (0.00%)  0/5 (0.00%)  0/6 (0.00%) 
Vascular disorders               
Thromboembolic event  1 [1]  1/5 (20.00%)  0/3 (0.00%)  0/3 (0.00%)  1/16 (6.25%)  0/18 (0.00%)  0/1 (0.00%)  0/0 
Thromboembolic event  1 [2]  1/4 (25.00%)  1/6 (16.67%)  0/7 (0.00%)  4/30 (13.33%)  0/25 (0.00%)  0/5 (0.00%)  0/6 (0.00%) 
1
Term from vocabulary, CTCv5
Indicates events were collected by systematic assessment
[1]
Pediatric
[2]
Adult
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Dose-Finding Level 1 CR Dose-Finding Level 1 RT Dose-Finding Level 2 RT Regimen A Regimen B Regimen C Regimen D
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   4/9 (44.44%)   2/9 (22.22%)   5/10 (50.00%)   20/46 (43.48%)   10/43 (23.26%)   1/6 (16.67%)   0/6 (0.00%) 
Blood and lymphatic system disorders               
Anemia  1 [1]  0/4 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  1/30 (3.33%)  0/25 (0.00%)  0/5 (0.00%)  0/6 (0.00%) 
Febrile neutropenia  1 [1]  0/4 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  1/30 (3.33%)  2/25 (8.00%)  0/5 (0.00%)  0/6 (0.00%) 
Cardiac disorders               
Cardiac disorders - Other, specify  1 [2]  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/16 (6.25%)  0/18 (0.00%)  0/1 (0.00%)  0/0 
General disorders               
Localized edema  1 [2]  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/16 (6.25%)  0/18 (0.00%)  0/1 (0.00%)  0/0 
Fatigue  1 [1]  0/4 (0.00%)  1/6 (16.67%)  0/7 (0.00%)  1/30 (3.33%)  0/25 (0.00%)  0/5 (0.00%)  0/6 (0.00%) 
Infections and infestations               
Infections and infestations - Other, specify  1 [1]  0/4 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/30 (0.00%)  1/25 (4.00%)  0/5 (0.00%)  0/6 (0.00%) 
Urinary tract infection  1 [1]  0/4 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  1/30 (3.33%)  0/25 (0.00%)  0/5 (0.00%)  0/6 (0.00%) 
Wound infection  1 [1]  0/4 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  1/30 (3.33%)  0/25 (0.00%)  0/5 (0.00%)  0/6 (0.00%) 
Injury, poisoning and procedural complications               
Radiation recall reaction (dermatologic)  1 [2]  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/16 (6.25%)  0/18 (0.00%)  0/1 (0.00%)  0/0 
Wound dehiscence  1 [2]  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/16 (6.25%)  0/18 (0.00%)  0/1 (0.00%)  0/0 
Wound complication  1 [2]  1/5 (20.00%)  0/3 (0.00%)  0/3 (0.00%)  0/16 (0.00%)  0/18 (0.00%)  0/1 (0.00%)  0/0 
Wound dehiscence  1 [1]  0/4 (0.00%)  0/6 (0.00%)  2/7 (28.57%)  0/30 (0.00%)  0/25 (0.00%)  0/5 (0.00%)  0/6 (0.00%) 
Wound complication  1 [1]  0/4 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/30 (0.00%)  0/25 (0.00%)  1/5 (20.00%)  0/6 (0.00%) 
Investigations               
Alanine aminotransferase increased  1 [2]  1/5 (20.00%)  0/3 (0.00%)  0/3 (0.00%)  1/16 (6.25%)  0/18 (0.00%)  0/1 (0.00%)  0/0 
Lymphocyte count decreased  1 [2]  1/5 (20.00%)  0/3 (0.00%)  0/3 (0.00%)  3/16 (18.75%)  2/18 (11.11%)  0/1 (0.00%)  0/0 
Neutrophil count decreased  1 [2]  1/5 (20.00%)  0/3 (0.00%)  0/3 (0.00%)  4/16 (25.00%)  5/18 (27.78%)  0/1 (0.00%)  0/0 
Platelet count decreased  1 [2]  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  3/16 (18.75%)  2/18 (11.11%)  0/1 (0.00%)  0/0 
White blood cell decreased  1 [2]  1/5 (20.00%)  0/3 (0.00%)  0/3 (0.00%)  4/16 (25.00%)  3/18 (16.67%)  0/1 (0.00%)  0/0 
Alanine aminotransferase increased  1 [1]  0/4 (0.00%)  0/6 (0.00%)  1/7 (14.29%)  0/30 (0.00%)  1/25 (4.00%)  0/5 (0.00%)  0/6 (0.00%) 
Aspartate aminotransferase increased  1 [1]  0/4 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/30 (0.00%)  1/25 (4.00%)  0/5 (0.00%)  0/6 (0.00%) 
Lipase increased  1 [1]  0/4 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/30 (0.00%)  1/25 (4.00%)  0/5 (0.00%)  0/6 (0.00%) 
Lymphocyte count decreased  1 [1]  1/4 (25.00%)  0/6 (0.00%)  1/7 (14.29%)  2/30 (6.67%)  3/25 (12.00%)  0/5 (0.00%)  0/6 (0.00%) 
Neutrophil count decreased  1 [1]  1/4 (25.00%)  0/6 (0.00%)  0/7 (0.00%)  10/30 (33.33%)  2/25 (8.00%)  0/5 (0.00%)  0/6 (0.00%) 
Platelet count decreased  1 [1]  0/4 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  5/30 (16.67%)  2/25 (8.00%)  0/5 (0.00%)  0/6 (0.00%) 
White blood cell decreased  1 [1]  1/4 (25.00%)  0/6 (0.00%)  0/7 (0.00%)  6/30 (20.00%)  2/25 (8.00%)  0/5 (0.00%)  0/6 (0.00%) 
Metabolism and nutrition disorders               
Hyperkalemia  1 [1]  0/4 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/30 (0.00%)  1/25 (4.00%)  0/5 (0.00%)  0/6 (0.00%) 
Hyperphosphatemia  1 [1]  0/4 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/30 (0.00%)  1/25 (4.00%)  0/5 (0.00%)  0/6 (0.00%) 
Hypokalemia  1 [1]  0/4 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  1/30 (3.33%)  0/25 (0.00%)  0/5 (0.00%)  0/6 (0.00%) 
Skin and subcutaneous tissue disorders               
Palmar-plantar erythrodysesthesia syndrome  1 [1]  0/4 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  1/30 (3.33%)  0/25 (0.00%)  0/5 (0.00%)  0/6 (0.00%) 
Vascular disorders               
Hypertension  1 [2]  1/5 (20.00%)  0/3 (0.00%)  0/3 (0.00%)  0/16 (0.00%)  0/18 (0.00%)  0/1 (0.00%)  0/0 
Hypertension  1 [1]  0/4 (0.00%)  1/6 (16.67%)  1/7 (14.29%)  0/30 (0.00%)  0/25 (0.00%)  1/5 (20.00%)  0/6 (0.00%) 
Hypotension  1 [1]  0/4 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  1/30 (3.33%)  0/25 (0.00%)  0/5 (0.00%)  0/6 (0.00%) 
1
Term from vocabulary, CTCv5
Indicates events were collected by systematic assessment
[1]
Adult
[2]
Pediatric
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Results Reporting Coordinator
Organization: Children's Oncology Group
Phone: 626-447-0064
EMail: resultsreportingcoordinator@childrensoncologygroup.org
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT02180867    
Other Study ID Numbers: NCI-2014-01340
NCI-2014-01340 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
ARST1321
s14-02023
ARST1321 ( Other Identifier: Children's Oncology Group )
ARST1321 ( Other Identifier: CTEP )
U10CA180830 ( U.S. NIH Grant/Contract )
U10CA180886 ( U.S. NIH Grant/Contract )
U10CA098543 ( U.S. NIH Grant/Contract )
First Submitted: July 1, 2014
First Posted: July 3, 2014
Results First Submitted: June 24, 2020
Results First Posted: October 9, 2020
Last Update Posted: October 4, 2021