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Stereotactic Body Radiation Therapy in Treating Patients With Stage I Non-Small Cell Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00750269
Recruitment Status : Active, not recruiting
First Posted : September 10, 2008
Results First Posted : May 10, 2017
Last Update Posted : May 7, 2019
Sponsor:
Collaborators:
National Cancer Institute (NCI)
NRG Oncology
Information provided by (Responsible Party):
Radiation Therapy Oncology Group

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Lung Cancer
Interventions Radiation: SBRT 40.0 Gy
Radiation: SBRT 42.5 Gy
Radiation: SBRT 45.0 Gy
Radiation: SBRT 47.5 Gy
Radiation: SBRT 50.0 Gy
Radiation: SBRT 52.5 Gy
Radiation: SBRT 55.0 Gy
Radiation: SBRT 57.5 Gy
Radiation: SBRT 60.0 Gy
Enrollment 120
Recruitment Details This study was designed to start at dose level 5. Dose levels 1-4 were in place only to be used if the regimen in general proved too toxic and lower dose levels were needed. No patients were accrued to levels 1-4.
Pre-assignment Details  
Arm/Group Title Level 5: 10.0 Gy/FX Level 6: 10.5 Gy/FX Level 7: 11.0 Gy/FX Level 8: 11.5 Gy/FX Level 9: 12.0 Gy/FX
Hide Arm/Group Description

SBRT 50.0 Gy

SBRT delivered in 5 fractions of 10.0 Gy/fraction over 1.5 to 2 weeks for a total of 50.0 Gy

SBRT 52.5 Gy

SBRT delivered in 5 fractions of 10.5 Gy/fraction over 1.5 to 2 weeks for a total of 52.5 Gy

SBRT 55.0 Gy

SBRT delivered in 5 fractions of 11.0 Gy/fraction over 1.5 to 2 weeks for a total of 55.0 Gy

SBRT 57.5 Gy

SBRT delivered in 5 fractions of 11.5 Gy/fraction over 1.5 to 2 weeks for a total of 57.5 Gy

SBRT 60.0 Gy

SBRT delivered in 5 fractions of 12.0 Gy/fraction over 1.5 to 2 weeks for a total of 60.0 Gy

Period Title: Overall Study
Started 8 8 18 43 43
Completed 8 [1] 7 14 38 33
Not Completed 0 1 4 5 10
Reason Not Completed
Protocol Violation             0             1             1             2             4
Withdrawal by Subject             0             0             2             2             2
Physician Decision             0             0             0             0             2
Patient too large for positioning             0             0             1             0             0
Site error             0             0             0             1             0
SBRT plan could not be drawn             0             0             0             0             1
Fiducials could not be placed             0             0             0             0             1
[1]
Subjects contributing data to the primary analysis are considered to have completed the study
Arm/Group Title Level 5: 10.0 Gy/FX Level 6: 10.5 Gy/FX Level 7: 11.0 Gy/FX Level 8: 11.5 Gy/FX Level 9: 12.0 Gy/FX Total
Hide Arm/Group Description

SBRT 50.0 Gy

SBRT delivered in 5 fractions of 10.0 Gy/fraction over 1.5 to 2 weeks for a total of 50.0 Gy

SBRT 52.5 Gy

SBRT delivered in 5 fractions of 10.5 Gy/fraction over 1.5 to 2 weeks for a total of 52.5 Gy

SBRT 55.0 Gy

SBRT delivered in 5 fractions of 11.0 Gy/fraction over 1.5 to 2 weeks for a total of 55.0 Gy

SBRT 57.5 Gy

SBRT delivered in 5 fractions of 11.5 Gy/fraction over 1.5 to 2 weeks for a total of 57.5 Gy

SBRT 60.0 Gy

SBRT delivered in 5 fractions of 12.0 Gy/fraction over 1.5 to 2 weeks for a total of 60.0 Gy

Total of all reporting groups
Overall Number of Baseline Participants 8 7 14 38 33 100
Hide Baseline Analysis Population Description
All eligible patients receiving protocol treatment
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 8 participants 7 participants 14 participants 38 participants 33 participants 100 participants
74
(59 to 81)
75
(53 to 89)
72
(59 to 81)
71
(52 to 87)
72
(55 to 89)
72
(52 to 89)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 7 participants 14 participants 38 participants 33 participants 100 participants
Female
6
  75.0%
3
  42.9%
6
  42.9%
15
  39.5%
13
  39.4%
43
  43.0%
Male
2
  25.0%
4
  57.1%
8
  57.1%
23
  60.5%
20
  60.6%
57
  57.0%
1.Primary Outcome
Title (Phase I) Maximum Tolerated Dose of Stereotactic Body Radiotherapy (SBRT) as Assessed by NCI Common Toxicity Criteria for Adverse Effects (CTCAE) v4.0
Hide Description Maximum tolerated dose (MTD) defined as dose most closely associated with a 20% probability of experiencing a toxicity <= 1 year from start of SBRT from following dose-limiting toxicities: Gr 3-5 Cardiac: Pericardial effusion, Pericarditis, Restrictive cardiomyopathy; Gr 4-5 GI: Dysphagia, Esophagitis, Esophageal fistula/obstruction/perforation/stenosis/ulcer/hemorrhage; Gr 3-5 Nervous System Disorders: Brachial plexopathy, Recurrent laryngeal nerve palsy, Myelitis; Gr 3-5 Respiratory: Atelectasis (gr 4-5 only), Bronchopulmonary/mediastinal/pleural/tracheal hemorrhage, Bronchial/pulmonary/bronchopleural/tracheal fistula, Hypoxia (provided gr 3 is worse than baseline), Bronchial/tracheal obstruction, Pleural effusion, Pneumonitis, Pulmonary fibrosis; Changes in Pulmonary Function Tests per SBRT Pulmonary Toxicity Scale, Gr 3-5: FEV1 decline, FVC decline; Any Gr 5 adverse event attributed to treatment. Dose level was determined by time-to-event continual reassessment method (TITE-CRM).
Time Frame From start of SBRT to 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
All eligible patients who started study treatment
Arm/Group Title All Participants
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 100
Measure Type: Number
Unit of Measure: Gy/FX
12.0
2.Primary Outcome
Title (Phase II) Primary Tumor Control Rate at the Maximum Tolerated Dose (MTD)
Hide Description Primary tumor control is defined as the absence of primary tumor failure. Primary tumor failure (PTF) refers to the primary treated tumor after protocol therapy and corresponds to meeting following two criteria: 1) Increase in tumor dimension of 20% as defined above for local enlargement (LE); 2) The measurable tumor with criteria meeting LE should be avid on Positron Emission Tomography (PET) imaging with uptake of a similar intensity as the pretreatment staging PET, OR the measurable tumor should be biopsied confirming viable carcinoma. Marginal Failures (MF) and Involved Lobe Failures were also counted as PTF. The cumulative incidence method was used to estimate primary tumor control rate. The 90% confidence interval for local control was calculated using bootstrapping methods. Per the protocol, only the MTD dose level was to be analyzed. However, due to the quantity of patients enrolled on Dose Level 8 as well as safety concerns, Dose Level 8 was analyzed also.
Time Frame From start of SBRT to 2 years.
Hide Outcome Measure Data
Hide Analysis Population Description
All eligible patients who started study treatment
Arm/Group Title Level 8: 11.5 Gy/FX Level 9: 12.0 Gy/FX
Hide Arm/Group Description:

SBRT 57.5 Gy

SBRT delivered in 5 fractions of 11.5 Gy/fraction over 1.5 to 2 weeks for a total of 57.5 Gy

SBRT 60.0 Gy

SBRT delivered in 5 fractions of 12.0 Gy/fraction over 1.5 to 2 weeks for a total of 60.0 Gy

Overall Number of Participants Analyzed 38 33
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: percentage of participants
89.4
(81.6 to 97.4)
87.7
(78.3 to 97)
3.Secondary Outcome
Title Progression-free Survival
Hide Description Progression-free survival is defined as the state of being alive without progression of disease. A failure is the first of the following: local progression, regional progression, distant metastasis, or death. Progression-free survival was assessed at the maximum tolerated dose using the Kaplan-Meier method to estimate the 2-year survival rate. Arms were not compared/tested.
Time Frame From randomization to date of death, failure (local, regional or distant) or last follow-up. Analysis occurs after all patients have been potentially followed for 24 months, approximately 7.5 years from the start of the study.
Hide Outcome Measure Data
Hide Analysis Population Description
All eligible patients who started study treatment
Arm/Group Title Level 5: 10.0 Gy/FX Level 6: 10.5 Gy/FX Level 7: 11.0 Gy/FX Level 8: 11.5 Gy/FX Level 9: 12.0 Gy/FX
Hide Arm/Group Description:
SBRT delivered in 5 fractions of 10.5 Gy/fraction over 1.5 to 2 weeks for a total of 52.5 Gy
SBRT delivered in 5 fractions of 10.5 Gy/fraction over 1.5 to 2 weeks for a total of 52.5 Gy
SBRT delivered in 5 fractions of 11.0 Gy/fraction over 1.5 to 2 weeks for a total of 55.0 Gy

SBRT 57.5 Gy

SBRT delivered in 5 fractions of 11.5 Gy/fraction over 1.5 to 2 weeks for a total of 57.5 Gy

SBRT 60.0 Gy

SBRT delivered in 5 fractions of 12.0 Gy/fraction over 1.5 to 2 weeks for a total of 60.0 Gy

Overall Number of Participants Analyzed 8 7 14 38 33
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
50.0
(15.2 to 77.5)
57.1
(17.2 to 83.7)
57.1
(28.4 to 78.0)
52.2
(35.3 to 66.6)
54.5
(36.3 to 69.6)
4.Secondary Outcome
Title Overall Survival
Hide Description An event for overall survival is death due to any cause. Overall survival was assessed at the maximum tolerated dose using the Kaplan-Meier method to estimate the 2-year survival rate. Arms were not compared/tested.
Time Frame From randomization to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 24 months, approximately 7.5 years from the start of the study.
Hide Outcome Measure Data
Hide Analysis Population Description
All eligible patients who started study treatment
Arm/Group Title Level 5: 10.0 Gy/FX Level 6: 10.5 Gy/FX Level 7: 11.0 Gy/FX Level 8: 11.5 Gy/FX Level 9: 12.0 Gy/FX
Hide Arm/Group Description:
SBRT delivered in 5 fractions of 10.0 Gy/fraction over 1.5 to 2 weeks for a total of 50.0 Gy
SBRT delivered in 5 fractions of 10.5 Gy/fraction over 1.5 to 2 weeks for a total of 52.5 Gy
SBRT delivered in 5 fractions of 11.0 Gy/fraction over 1.5 to 2 weeks for a total of 55.0 Gy

SBRT 57.5 Gy

SBRT delivered in 5 fractions of 11.5 Gy/fraction over 1.5 to 2 weeks for a total of 57.5 Gy

SBRT 60.0 Gy

SBRT delivered in 5 fractions of 12.0 Gy/fraction over 1.5 to 2 weeks for a total of 60.0 Gy

Overall Number of Participants Analyzed 8 7 14 38 33
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
75.0
(31.5 to 93.1)
57.1
(17.2 to 83.7)
71.4
(40.6 to 88.2)
70.2
(52.6 to 82.3)
72.7
(54.1 to 84.8)
5.Secondary Outcome
Title Local Progression
Hide Description Local progression is the same as primary tumor failure (PTF) which refers to the primary treated tumor after protocol therapy and corresponds to meeting both of the following two criteria: 1) Increase in tumor dimension of 20% as defined above for local enlargement (LE); 2) The measurable tumor with criteria meeting LE should be avid on Positron Emission Tomography (PET) imaging with uptake of a similar intensity as the pretreatment staging PET, OR the measurable tumor should be biopsied confirming viable carcinoma. For outcome analysis, Marginal Failures (MF) and Involved Lobe Failures will also be counted as PTF. Local progression was assessed using the cumulative incidence method to estimate the 2-year failure rate. Arms were not compared/tested.
Time Frame From randomization to date of death, regional failure or last follow-up. Analysis occurs after all patients have been potentially followed for 24 months.
Hide Outcome Measure Data
Hide Analysis Population Description
All eligible patients who started study treatment
Arm/Group Title Level 5: 10.0 Gy/FX Level 6: 10.5 Gy/FX Level 7: 11.0 Gy/FX Level 8: 11.5 Gy/FX Level 9: 12.0 Gy/FX
Hide Arm/Group Description:
SBRT delivered in 5 fractions of 10.0 Gy/fraction over 1.5 to 2 weeks for a total of 50.0 Gy
SBRT delivered in 5 fractions of 10.5 Gy/fraction over 1.5 to 2 weeks for a total of 52.5 Gy
SBRT delivered in 5 fractions of 11.0 Gy/fraction over 1.5 to 2 weeks for a total of 55.0 Gy

SBRT 57.5 Gy

SBRT delivered in 5 fractions of 11.5 Gy/fraction over 1.5 to 2 weeks for a total of 57.5 Gy

SBRT 60.0 Gy

SBRT delivered in 5 fractions of 12.0 Gy/fraction over 1.5 to 2 weeks for a total of 60.0 Gy

Overall Number of Participants Analyzed 8 7 14 38 33
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
12.5
(0.5 to 44.5)
0 [1] 
(NA to NA)
14.3
(2.1 to 37.7)
10.6
(3.3 to 22.9)
12.3
(3.8 to 26.1)
[1]
A confidence interval cannot be computed when the rate is zero, i.e. when there are zero events.
6.Secondary Outcome
Title Nodal Progression
Hide Description Regional nodal progression is defined as appearance after protocol therapy of measurable tumor within lymph nodes along the natural lymphatic drainage typical for the location of the treated primary disease only with dimension of at least 1.0 cm on imaging studies (preferably CT scans) within the lung, bronchial hilum, or the mediastinum. Regional nodal progression was assessed using the cumulative incidence method to estimate the 2-year failure rate. Arms were not compared/tested.
Time Frame From randomization to date of death, regional failure or last follow-up. Analysis occurs after all patients have been potentially followed for 24 months, approximately 7.5 years from the start of the study.
Hide Outcome Measure Data
Hide Analysis Population Description
All eligible patients who started study treatment
Arm/Group Title Level 5: 10.0 Gy/FX Level 6: 10.5 Gy/FX Level 7: 11.0 Gy/FX Level 8: 11.5 Gy/FX Level 9: 12.0 Gy/FX
Hide Arm/Group Description:
SBRT delivered in 5 fractions of 10.0 Gy/fraction over 1.5 to 2 weeks for a total of 50.0 Gy
SBRT delivered in 5 fractions of 10.5 Gy/fraction over 1.5 to 2 weeks for a total of 52.5 Gy
SBRT delivered in 5 fractions of 11.0 Gy/fraction over 1.5 to 2 weeks for a total of 55.0 Gy

SBRT 57.5 Gy

SBRT delivered in 5 fractions of 11.5 Gy/fraction over 1.5 to 2 weeks for a total of 57.5 Gy

SBRT 60.0 Gy

SBRT delivered in 5 fractions of 12.0 Gy/fraction over 1.5 to 2 weeks for a total of 60.0 Gy

Overall Number of Participants Analyzed 8 7 14 38 33
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of patients
0 [1] 
(NA to NA)
0 [1] 
(NA to NA)
7.1
(0.4 to 28.7)
5.3
(0.9 to 15.7)
6.1
(1 to 17.9)
[1]
A confidence interval cannot be computed when the rate is zero, i.e. when there are zero events.
7.Secondary Outcome
Title Distant Metastases
Hide Description Distant metastases is defined as the appearance after protocol therapy of cancer deposits characteristic of metastatic dissemination from non-small cell lung cancer. Distant metastases progression was assessed using the cumulative incidence method to estimate the 2-year failure rate. Arms were not compared/tested.
Time Frame From randomization to date of death, distant failure or last follow-up. Analysis occurs after all patients have been potentially followed for 24 months, approximately 7.5 years from the start of the study.
Hide Outcome Measure Data
Hide Analysis Population Description
All eligible patients who started study treatment
Arm/Group Title Level 5: 10.0 Gy/FX Level 6: 10.5 Gy/FX Level 7: 11.0 Gy/FX Level 8: 11.5 Gy/FX Level 9: 12.0 Gy/FX
Hide Arm/Group Description:
SBRT delivered in 5 fractions of 10.0 Gy/fraction over 1.5 to 2 weeks for a total of 50.0 Gy
SBRT delivered in 5 fractions of 10.5 Gy/fraction over 1.5 to 2 weeks for a total of 52.5 Gy
SBRT delivered in 5 fractions of 11.0 Gy/fraction over 1.5 to 2 weeks for a total of 55.0 Gy

SBRT 57.5 Gy

SBRT delivered in 5 fractions of 11.5 Gy/fraction over 1.5 to 2 weeks for a total of 57.5 Gy

SBRT 60.0 Gy

SBRT delivered in 5 fractions of 12.0 Gy/fraction over 1.5 to 2 weeks for a total of 60.0 Gy

Overall Number of Participants Analyzed 8 7 14 38 33
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
0 [1] 
(NA to NA)
14.3
(0.4 to 50.3)
14.3
(2.1 to 37.6)
7.9
(2 to 19.3)
15.2
(5.4 to 29.5)
[1]
A confidence interval cannot be computed when the rate is zero, i.e. when there are zero events.
8.Secondary Outcome
Title Rate of Toxicity ≥ Grade 3 (Other Than DLT) Within One Year as Assessed by NCI CTCAE v4.0
Hide Description Rate of patients developing any treatment-related toxicity during the first year following the start of SBRT that is not among the types considered as a dose-limiting toxicity.
Time Frame From start of SBRT until 1 year.
Hide Outcome Measure Data
Hide Analysis Population Description
All eligible patients who started study treatment
Arm/Group Title Level 5: 10.0 Gy/FX Level 6: 10.5 Gy/FX Level 7: 11.0 Gy/FX Level 8: 11.5 Gy/FX Level 9: 12.0 Gy/FX
Hide Arm/Group Description:

SBRT 50.0 Gy

SBRT delivered in 5 fractions of 10.0 Gy/fraction over 1.5 to 2 weeks for a total of 50.0 Gy

SBRT 52.5 Gy

SBRT delivered in 5 fractions of 10.5 Gy/fraction over 1.5 to 2 weeks for a total of 52.5 Gy

SBRT 55.0 Gy

SBRT delivered in 5 fractions of 11.0 Gy/fraction over 1.5 to 2 weeks for a total of 55.0 Gy

SBRT 57.5 Gy

SBRT delivered in 5 fractions of 11.5 Gy/fraction over 1.5 to 2 weeks for a total of 57.5 Gy

SBRT 60.0 Gy

SBRT delivered in 5 fractions of 12.0 Gy/fraction over 1.5 to 2 weeks for a total of 60.0 Gy

Overall Number of Participants Analyzed 8 7 14 38 33
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
0
(0 to 0)
0
(0 to 0)
0
(0 to 0)
12.1
(2.9 to 24.8)
16.7
(3.4 to 28.2)
9.Secondary Outcome
Title Rate of Late Toxicity (i.e., Occurs > 1 Year After the Start of SBRT) of ≥ Grade 3 as Assessed by NCI CTCAE v4.0
Hide Description Percentage of patients who developed any treatment-related toxicity after the first year following the start of SBRT.
Time Frame From start of treatment to end of follow-up. Analysis occurs after all patients have been potentially followed for 24 months, approximately 7.5 years from the start of the study.
Hide Outcome Measure Data
Hide Analysis Population Description
All eligible patients who started study treatment who were observed more than 1 year after start of SBRT
Arm/Group Title Level 5: 10.0 Gy/FX Level 6: 10.5 Gy/FX Level 7: 11.0 Gy/FX Level 8: 11.5 Gy/FX Level 9: 12.0 Gy/FX
Hide Arm/Group Description:

SBRT 50.0 Gy

SBRT delivered in 5 fractions of 10.0 Gy/fraction over 1.5 to 2 weeks for a total of 50.0 Gy

SBRT 52.5 Gy

SBRT delivered in 5 fractions of 10.5 Gy/fraction over 1.5 to 2 weeks for a total of 52.5 Gy

SBRT 55.0 Gy

SBRT delivered in 5 fractions of 11.0 Gy/fraction over 1.5 to 2 weeks for a total of 55.0 Gy

SBRT 57.5 Gy

SBRT delivered in 5 fractions of 11.5 Gy/fraction over 1.5 to 2 weeks for a total of 57.5 Gy

SBRT 60.0 Gy

SBRT delivered in 5 fractions of 12.0 Gy/fraction over 1.5 to 2 weeks for a total of 60.0 Gy

Overall Number of Participants Analyzed 8 5 12 32 31
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
0
(0 to 0)
0
(0 to 0)
16.7
(2.1 to 48.4)
6.3
(0.8 to 20.8)
16.1
(5.5 to 33.7)
Time Frame [Not Specified]
Adverse Event Reporting Description Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
 
Arm/Group Title Level 5: 10.0 Gy/FX Level 6: 10.5 Gy/FX Level 7: 11.0 Gy/FX Level 8: 11.5 Gy/FX Level 9: 12.0 Gy/FX
Hide Arm/Group Description

SBRT 50.0 Gy

SBRT delivered in 5 fractions of 10.0 Gy/fraction over 1.5 to 2 weeks for a total of 50.0 Gy

SBRT 52.5 Gy

SBRT delivered in 5 fractions of 10.5 Gy/fraction over 1.5 to 2 weeks for a total of 52.5 Gy

SBRT 55.0 Gy

SBRT delivered in 5 fractions of 11.0 Gy/fraction over 1.5 to 2 weeks for a total of 55.0 Gy

SBRT 57.5 Gy

SBRT delivered in 5 fractions of 11.5 Gy/fraction over 1.5 to 2 weeks for a total of 57.5 Gy

SBRT 60.0 Gy

SBRT delivered in 5 fractions of 12.0 Gy/fraction over 1.5 to 2 weeks for a total of 60.0 Gy

All-Cause Mortality
Level 5: 10.0 Gy/FX Level 6: 10.5 Gy/FX Level 7: 11.0 Gy/FX Level 8: 11.5 Gy/FX Level 9: 12.0 Gy/FX
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/-- 
Hide Serious Adverse Events
Level 5: 10.0 Gy/FX Level 6: 10.5 Gy/FX Level 7: 11.0 Gy/FX Level 8: 11.5 Gy/FX Level 9: 12.0 Gy/FX
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/8 (12.50%)   0/7 (0.00%)   2/14 (14.29%)   9/38 (23.68%)   7/33 (21.21%) 
Cardiac disorders           
Heart failure * 1  0/8 (0.00%)  0/7 (0.00%)  0/14 (0.00%)  0/38 (0.00%)  1/33 (3.03%) 
Sinus bradycardia  1  0/8 (0.00%)  0/7 (0.00%)  1/14 (7.14%)  0/38 (0.00%)  0/33 (0.00%) 
Sinus tachycardia * 1  0/8 (0.00%)  0/7 (0.00%)  0/14 (0.00%)  1/38 (2.63%)  0/33 (0.00%) 
Gastrointestinal disorders           
Dysphagia  1  1/8 (12.50%)  0/7 (0.00%)  0/14 (0.00%)  1/38 (2.63%)  0/33 (0.00%) 
Esophageal perforation  1  0/8 (0.00%)  0/7 (0.00%)  0/14 (0.00%)  0/38 (0.00%)  1/33 (3.03%) 
Esophagitis  1  1/8 (12.50%)  0/7 (0.00%)  0/14 (0.00%)  1/38 (2.63%)  1/33 (3.03%) 
Gastritis * 1  0/8 (0.00%)  0/7 (0.00%)  0/14 (0.00%)  1/38 (2.63%)  0/33 (0.00%) 
General disorders           
Death NOS  1  0/8 (0.00%)  0/7 (0.00%)  0/14 (0.00%)  1/38 (2.63%)  0/33 (0.00%) 
Infections and infestations           
Lung infection * 1  0/8 (0.00%)  0/7 (0.00%)  0/14 (0.00%)  1/38 (2.63%)  0/33 (0.00%) 
Nervous system disorders           
Intracranial hemorrhage * 1  0/8 (0.00%)  0/7 (0.00%)  0/14 (0.00%)  1/38 (2.63%)  0/33 (0.00%) 
Respiratory, thoracic and mediastinal disorders           
Atelectasis  1  0/8 (0.00%)  0/7 (0.00%)  0/14 (0.00%)  2/38 (5.26%)  1/33 (3.03%) 
Bronchial obstruction  1  0/8 (0.00%)  0/7 (0.00%)  0/14 (0.00%)  0/38 (0.00%)  1/33 (3.03%) 
Bronchopulmonary hemorrhage  1  0/8 (0.00%)  0/7 (0.00%)  0/14 (0.00%)  2/38 (5.26%)  1/33 (3.03%) 
Cough * 1  0/8 (0.00%)  0/7 (0.00%)  0/14 (0.00%)  1/38 (2.63%)  0/33 (0.00%) 
Dyspnea * 1  0/8 (0.00%)  0/7 (0.00%)  0/14 (0.00%)  3/38 (7.89%)  1/33 (3.03%) 
Hypoxia  1  0/8 (0.00%)  0/7 (0.00%)  0/14 (0.00%)  2/38 (5.26%)  1/33 (3.03%) 
Pleural effusion  1  0/8 (0.00%)  0/7 (0.00%)  0/14 (0.00%)  0/38 (0.00%)  1/33 (3.03%) 
Pneumonitis  1  0/8 (0.00%)  0/7 (0.00%)  0/14 (0.00%)  0/38 (0.00%)  1/33 (3.03%) 
Pulmonary fibrosis  1  0/8 (0.00%)  0/7 (0.00%)  0/14 (0.00%)  0/38 (0.00%)  1/33 (3.03%) 
Respiratory failure  1  0/8 (0.00%)  0/7 (0.00%)  1/14 (7.14%)  1/38 (2.63%)  0/33 (0.00%) 
Respiratory, thoracic and mediastinal disorders - Other * 1  0/8 (0.00%)  0/7 (0.00%)  1/14 (7.14%)  0/38 (0.00%)  2/33 (6.06%) 
Vascular disorders           
Hypertension * 1  0/8 (0.00%)  0/7 (0.00%)  0/14 (0.00%)  1/38 (2.63%)  0/33 (0.00%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (4.0)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Level 5: 10.0 Gy/FX Level 6: 10.5 Gy/FX Level 7: 11.0 Gy/FX Level 8: 11.5 Gy/FX Level 9: 12.0 Gy/FX
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   7/8 (87.50%)   7/7 (100.00%)   13/14 (92.86%)   34/38 (89.47%)   27/33 (81.82%) 
Cardiac disorders           
Chest pain - cardiac * 1  1/8 (12.50%)  0/7 (0.00%)  0/14 (0.00%)  0/38 (0.00%)  0/33 (0.00%) 
Conduction disorder * 1  1/8 (12.50%)  0/7 (0.00%)  0/14 (0.00%)  0/38 (0.00%)  0/33 (0.00%) 
Heart failure * 1  0/8 (0.00%)  0/7 (0.00%)  0/14 (0.00%)  1/38 (2.63%)  2/33 (6.06%) 
Mitral valve disease * 1  1/8 (12.50%)  0/7 (0.00%)  0/14 (0.00%)  0/38 (0.00%)  0/33 (0.00%) 
Pericardial effusion  1  0/8 (0.00%)  0/7 (0.00%)  2/14 (14.29%)  1/38 (2.63%)  1/33 (3.03%) 
Pericarditis  1  0/8 (0.00%)  0/7 (0.00%)  1/14 (7.14%)  1/38 (2.63%)  1/33 (3.03%) 
Tricuspid valve disease * 1  1/8 (12.50%)  0/7 (0.00%)  0/14 (0.00%)  0/38 (0.00%)  0/33 (0.00%) 
Gastrointestinal disorders           
Constipation * 1  0/8 (0.00%)  0/7 (0.00%)  0/14 (0.00%)  2/38 (5.26%)  1/33 (3.03%) 
Diarrhea * 1  1/8 (12.50%)  0/7 (0.00%)  0/14 (0.00%)  1/38 (2.63%)  0/33 (0.00%) 
Dyspepsia * 1  0/8 (0.00%)  0/7 (0.00%)  0/14 (0.00%)  2/38 (5.26%)  0/33 (0.00%) 
Dysphagia  1  0/8 (0.00%)  0/7 (0.00%)  4/14 (28.57%)  5/38 (13.16%)  9/33 (27.27%) 
Esophageal fistula  1  0/8 (0.00%)  0/7 (0.00%)  1/14 (7.14%)  0/38 (0.00%)  1/33 (3.03%) 
Esophageal hemorrhage  1  0/8 (0.00%)  0/7 (0.00%)  2/14 (14.29%)  0/38 (0.00%)  0/33 (0.00%) 
Esophageal obstruction  1  0/8 (0.00%)  0/7 (0.00%)  2/14 (14.29%)  0/38 (0.00%)  1/33 (3.03%) 
Esophageal pain * 1  0/8 (0.00%)  1/7 (14.29%)  0/14 (0.00%)  2/38 (5.26%)  1/33 (3.03%) 
Esophageal stenosis  1  0/8 (0.00%)  0/7 (0.00%)  1/14 (7.14%)  0/38 (0.00%)  1/33 (3.03%) 
Esophageal ulcer  1  0/8 (0.00%)  0/7 (0.00%)  1/14 (7.14%)  1/38 (2.63%)  1/33 (3.03%) 
Esophagitis  1  0/8 (0.00%)  0/7 (0.00%)  2/14 (14.29%)  3/38 (7.89%)  2/33 (6.06%) 
Gastroesophageal reflux disease * 1  0/8 (0.00%)  0/7 (0.00%)  1/14 (7.14%)  1/38 (2.63%)  0/33 (0.00%) 
General disorders           
Death NOS  1  0/8 (0.00%)  1/7 (14.29%)  1/14 (7.14%)  0/38 (0.00%)  0/33 (0.00%) 
Edema limbs * 1  0/8 (0.00%)  0/7 (0.00%)  1/14 (7.14%)  1/38 (2.63%)  0/33 (0.00%) 
Fatigue * 1  4/8 (50.00%)  3/7 (42.86%)  6/14 (42.86%)  12/38 (31.58%)  8/33 (24.24%) 
Fever * 1  1/8 (12.50%)  0/7 (0.00%)  0/14 (0.00%)  2/38 (5.26%)  0/33 (0.00%) 
Pain * 1  2/8 (25.00%)  0/7 (0.00%)  0/14 (0.00%)  0/38 (0.00%)  2/33 (6.06%) 
Infections and infestations           
Bronchial infection * 1  0/8 (0.00%)  0/7 (0.00%)  1/14 (7.14%)  0/38 (0.00%)  1/33 (3.03%) 
Lung infection * 1  0/8 (0.00%)  0/7 (0.00%)  0/14 (0.00%)  2/38 (5.26%)  0/33 (0.00%) 
Sinusitis * 1  0/8 (0.00%)  0/7 (0.00%)  1/14 (7.14%)  1/38 (2.63%)  0/33 (0.00%) 
Skin infection * 1  0/8 (0.00%)  0/7 (0.00%)  1/14 (7.14%)  0/38 (0.00%)  0/33 (0.00%) 
Upper respiratory infection * 1  0/8 (0.00%)  0/7 (0.00%)  1/14 (7.14%)  0/38 (0.00%)  2/33 (6.06%) 
Wound infection * 1  0/8 (0.00%)  0/7 (0.00%)  1/14 (7.14%)  0/38 (0.00%)  0/33 (0.00%) 
Injury, poisoning and procedural complications           
Dermatitis radiation * 1  0/8 (0.00%)  0/7 (0.00%)  2/14 (14.29%)  0/38 (0.00%)  0/33 (0.00%) 
Fracture * 1  0/8 (0.00%)  0/7 (0.00%)  0/14 (0.00%)  2/38 (5.26%)  0/33 (0.00%) 
Tracheal hemorrhage  1  0/8 (0.00%)  0/7 (0.00%)  1/14 (7.14%)  0/38 (0.00%)  0/33 (0.00%) 
Tracheal obstruction  1  0/8 (0.00%)  0/7 (0.00%)  1/14 (7.14%)  0/38 (0.00%)  0/33 (0.00%) 
Investigations           
CD4 lymphocytes decreased * 1  0/8 (0.00%)  0/7 (0.00%)  0/14 (0.00%)  2/38 (5.26%)  0/33 (0.00%) 
Carbon monoxide diffusing capacity decreased * 1  2/8 (25.00%)  1/7 (14.29%)  1/14 (7.14%)  2/38 (5.26%)  1/33 (3.03%) 
Forced expiratory volume decreased * 1  1/8 (12.50%)  2/7 (28.57%)  3/14 (21.43%)  5/38 (13.16%)  1/33 (3.03%) 
Investigations - Other * 1  0/8 (0.00%)  0/7 (0.00%)  1/14 (7.14%)  0/38 (0.00%)  0/33 (0.00%) 
Vital capacity abnormal * 1  1/8 (12.50%)  1/7 (14.29%)  0/14 (0.00%)  1/38 (2.63%)  0/33 (0.00%) 
Weight loss * 1  1/8 (12.50%)  0/7 (0.00%)  0/14 (0.00%)  3/38 (7.89%)  2/33 (6.06%) 
Metabolism and nutrition disorders           
Anorexia * 1  1/8 (12.50%)  0/7 (0.00%)  0/14 (0.00%)  5/38 (13.16%)  3/33 (9.09%) 
Dehydration * 1  1/8 (12.50%)  0/7 (0.00%)  0/14 (0.00%)  0/38 (0.00%)  1/33 (3.03%) 
Musculoskeletal and connective tissue disorders           
Arthralgia * 1  0/8 (0.00%)  0/7 (0.00%)  1/14 (7.14%)  0/38 (0.00%)  0/33 (0.00%) 
Back pain * 1  0/8 (0.00%)  0/7 (0.00%)  1/14 (7.14%)  0/38 (0.00%)  2/33 (6.06%) 
Chest wall pain * 1  0/8 (0.00%)  0/7 (0.00%)  1/14 (7.14%)  3/38 (7.89%)  2/33 (6.06%) 
Flank pain * 1  0/8 (0.00%)  0/7 (0.00%)  0/14 (0.00%)  2/38 (5.26%)  0/33 (0.00%) 
Joint range of motion decreased * 1  0/8 (0.00%)  1/7 (14.29%)  0/14 (0.00%)  0/38 (0.00%)  0/33 (0.00%) 
Musculoskeletal and connective tissue disorder - Other * 1  0/8 (0.00%)  0/7 (0.00%)  0/14 (0.00%)  2/38 (5.26%)  0/33 (0.00%) 
Myositis * 1  0/8 (0.00%)  0/7 (0.00%)  1/14 (7.14%)  0/38 (0.00%)  1/33 (3.03%) 
Neck pain * 1  0/8 (0.00%)  0/7 (0.00%)  1/14 (7.14%)  0/38 (0.00%)  0/33 (0.00%) 
Pain in extremity * 1  0/8 (0.00%)  0/7 (0.00%)  1/14 (7.14%)  1/38 (2.63%)  0/33 (0.00%) 
Nervous system disorders           
Brachial plexopathy  1  0/8 (0.00%)  0/7 (0.00%)  1/14 (7.14%)  0/38 (0.00%)  0/33 (0.00%) 
Headache * 1  1/8 (12.50%)  1/7 (14.29%)  0/14 (0.00%)  0/38 (0.00%)  1/33 (3.03%) 
Myelitis  1  0/8 (0.00%)  0/7 (0.00%)  2/14 (14.29%)  0/38 (0.00%)  0/33 (0.00%) 
Neuralgia * 1  0/8 (0.00%)  0/7 (0.00%)  1/14 (7.14%)  0/38 (0.00%)  0/33 (0.00%) 
Recurrent laryngeal nerve palsy  1  0/8 (0.00%)  0/7 (0.00%)  1/14 (7.14%)  1/38 (2.63%)  1/33 (3.03%) 
Psychiatric disorders           
Anxiety * 1  0/8 (0.00%)  0/7 (0.00%)  1/14 (7.14%)  0/38 (0.00%)  0/33 (0.00%) 
Insomnia * 1  0/8 (0.00%)  0/7 (0.00%)  1/14 (7.14%)  0/38 (0.00%)  0/33 (0.00%) 
Renal and urinary disorders           
Renal and urinary disorders - Other * 1  0/8 (0.00%)  0/7 (0.00%)  1/14 (7.14%)  0/38 (0.00%)  0/33 (0.00%) 
Respiratory, thoracic and mediastinal disorders           
Allergic rhinitis * 1  0/8 (0.00%)  0/7 (0.00%)  1/14 (7.14%)  0/38 (0.00%)  0/33 (0.00%) 
Aspiration * 1  0/8 (0.00%)  0/7 (0.00%)  1/14 (7.14%)  0/38 (0.00%)  0/33 (0.00%) 
Atelectasis  1  5/8 (62.50%)  1/7 (14.29%)  3/14 (21.43%)  13/38 (34.21%)  13/33 (39.39%) 
Bronchial fistula  1  0/8 (0.00%)  0/7 (0.00%)  1/14 (7.14%)  0/38 (0.00%)  0/33 (0.00%) 
Bronchial obstruction  1  0/8 (0.00%)  0/7 (0.00%)  2/14 (14.29%)  3/38 (7.89%)  3/33 (9.09%) 
Bronchial stricture * 1  0/8 (0.00%)  0/7 (0.00%)  1/14 (7.14%)  0/38 (0.00%)  0/33 (0.00%) 
Bronchopleural fistula  1  0/8 (0.00%)  0/7 (0.00%)  1/14 (7.14%)  0/38 (0.00%)  0/33 (0.00%) 
Bronchopulmonary hemorrhage  1  0/8 (0.00%)  0/7 (0.00%)  1/14 (7.14%)  1/38 (2.63%)  0/33 (0.00%) 
Bronchospasm * 1  1/8 (12.50%)  0/7 (0.00%)  1/14 (7.14%)  0/38 (0.00%)  0/33 (0.00%) 
Cough * 1  3/8 (37.50%)  2/7 (28.57%)  3/14 (21.43%)  11/38 (28.95%)  4/33 (12.12%) 
Dyspnea * 1  5/8 (62.50%)  1/7 (14.29%)  5/14 (35.71%)  11/38 (28.95%)  11/33 (33.33%) 
Hypoxia  1  1/8 (12.50%)  2/7 (28.57%)  2/14 (14.29%)  8/38 (21.05%)  7/33 (21.21%) 
Laryngeal hemorrhage * 1  0/8 (0.00%)  0/7 (0.00%)  1/14 (7.14%)  0/38 (0.00%)  0/33 (0.00%) 
Mediastinal hemorrhage  1  0/8 (0.00%)  0/7 (0.00%)  1/14 (7.14%)  0/38 (0.00%)  0/33 (0.00%) 
Nasal congestion * 1  0/8 (0.00%)  0/7 (0.00%)  1/14 (7.14%)  0/38 (0.00%)  0/33 (0.00%) 
Pleural effusion  1  2/8 (25.00%)  3/7 (42.86%)  5/14 (35.71%)  7/38 (18.42%)  11/33 (33.33%) 
Pleural hemorrhage  1  0/8 (0.00%)  0/7 (0.00%)  1/14 (7.14%)  0/38 (0.00%)  0/33 (0.00%) 
Pleuritic pain * 1  0/8 (0.00%)  0/7 (0.00%)  1/14 (7.14%)  1/38 (2.63%)  0/33 (0.00%) 
Pneumonitis  1  4/8 (50.00%)  2/7 (28.57%)  3/14 (21.43%)  13/38 (34.21%)  5/33 (15.15%) 
Productive cough * 1  1/8 (12.50%)  0/7 (0.00%)  4/14 (28.57%)  2/38 (5.26%)  0/33 (0.00%) 
Pulmonary fibrosis  1  3/8 (37.50%)  2/7 (28.57%)  3/14 (21.43%)  5/38 (13.16%)  7/33 (21.21%) 
Pulmonary fistula  1  0/8 (0.00%)  0/7 (0.00%)  1/14 (7.14%)  0/38 (0.00%)  0/33 (0.00%) 
Respiratory, thoracic and mediastinal disorders - Other * 1  1/8 (12.50%)  0/7 (0.00%)  2/14 (14.29%)  1/38 (2.63%)  3/33 (9.09%) 
Sore throat * 1  0/8 (0.00%)  0/7 (0.00%)  2/14 (14.29%)  0/38 (0.00%)  0/33 (0.00%) 
Tracheal fistula  1  0/8 (0.00%)  0/7 (0.00%)  1/14 (7.14%)  0/38 (0.00%)  0/33 (0.00%) 
Wheezing * 1  0/8 (0.00%)  0/7 (0.00%)  2/14 (14.29%)  3/38 (7.89%)  2/33 (6.06%) 
Skin and subcutaneous tissue disorders           
Dry skin * 1  0/8 (0.00%)  0/7 (0.00%)  1/14 (7.14%)  0/38 (0.00%)  0/33 (0.00%) 
Rash acneiform * 1  0/8 (0.00%)  0/7 (0.00%)  1/14 (7.14%)  0/38 (0.00%)  1/33 (3.03%) 
Skin hyperpigmentation * 1  0/8 (0.00%)  1/7 (14.29%)  1/14 (7.14%)  0/38 (0.00%)  0/33 (0.00%) 
Vascular disorders           
Hot flashes * 1  0/8 (0.00%)  0/7 (0.00%)  0/14 (0.00%)  2/38 (5.26%)  0/33 (0.00%) 
Hypertension * 1  0/8 (0.00%)  0/7 (0.00%)  0/14 (0.00%)  2/38 (5.26%)  3/33 (9.09%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (4.0)
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.
PI's are required to abide by the sponsor's publication guidelines which require review by coauthors and subsequent review and approval by the sponsor.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Wendy Seiferheld, M.S.
Organization: NRG Oncology
EMail: seiferheldw@nrgoncology.org
Layout table for additonal information
Responsible Party: Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier: NCT00750269    
Obsolete Identifiers: NCT01317056
Other Study ID Numbers: RTOG-0813
CDR0000613524
NCI-2009-01095 ( Registry Identifier: CTRP (Clinical Trials Reporting Program) )
First Submitted: September 9, 2008
First Posted: September 10, 2008
Results First Submitted: June 30, 2016
Results First Posted: May 10, 2017
Last Update Posted: May 7, 2019