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Trial record 10 of 125 for:    colon cancer AND Rectal | ( Map: New Jersey, United States )

Combination Chemotherapy and Intensity-Modulated Radiation Therapy in Treating Patients Undergoing Surgery for Locally Advanced Rectal Cancer

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ClinicalTrials.gov Identifier: NCT00613080
Recruitment Status : Completed
First Posted : February 12, 2008
Results First Posted : June 10, 2013
Last Update Posted : September 25, 2018
Sponsor:
Collaborators:
National Cancer Institute (NCI)
NRG Oncology
Information provided by (Responsible Party):
Radiation Therapy Oncology Group

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Colorectal Cancer
Interventions Drug: capecitabine
Drug: oxaliplatin
Procedure: resection
Radiation: radiation therapy
Drug: FOLFOX
Enrollment 79
Recruitment Details  
Pre-assignment Details  
Arm/Group Title IMRT + Chemotherapy , Resection, Postoperative Chemotherapy
Hide Arm/Group Description Radiation therapy (intensity modulated radiation therapy [IMRT] + three dimensional conformal radiation therapy [3D-CRT]) + neoadjuvant chemotherapy (capecitabine and oxaliplatin) followed by resection and postoperative chemotherapy (FOLFOX)
Period Title: Overall Study
Started 79
Completed 68 [1]
Not Completed 11
Reason Not Completed
Ineligible / no protocol treatment             11
[1]
Subjects contributing data to the primary analysis are considered to have completed the study.
Arm/Group Title IMRT + Chemotherapy , Resection, Postoperative Chemotherapy
Hide Arm/Group Description Radiation therapy (intensity modulated radiation therapy [IMRT] + three dimensional conformal radiation therapy [3D-CRT]) + neoadjuvant chemotherapy (capecitabine and oxaliplatin) followed by resection and postoperative chemotherapy (FOLFOX)
Overall Number of Baseline Participants 68
Hide Baseline Analysis Population Description
All eligible patients.
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 68 participants
51
(29 to 77)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 68 participants
Female
30
  44.1%
Male
38
  55.9%
1.Primary Outcome
Title The Percentage of Patients Experiencing Treatment-related Gastrointestinal Adverse Events ≥ Grade 2 Per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v. 3.0, Occurring Preoperatively
Hide Description The percentage of patients experiencing preoperative treatment-related gastrointestinal adverse events ≥ grade 2. If patient did not receive surgery, then such adverse events <= 90 days from the start of concurrent treatment are included.
Time Frame From start of treatment to surgery or ≤ 90 days from the Start of Concurrent Treatment (for patients not undergoing surgery)
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible subjects who started study treatment.
Arm/Group Title IMRT + Chemotherapy , Resection, Postoperative Chemotherapy
Hide Arm/Group Description:
Radiation therapy (intensity modulated radiation therapy [IMRT] + three dimensional conformal radiation therapy [3D-CRT]) + neoadjuvant chemotherapy (capecitabine and oxaliplatin) followed by resection and postoperative chemotherapy (FOLFOX)
Overall Number of Participants Analyzed 68
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: percentage of patients
51 [1] 
(NA to 59)
[1]
This is a one-sided confidence interval.
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IMRT + Chemotherapy , Resection, Postoperative Chemotherapy
Comments This study was designed for a one-sided chi-square test to detect at least 12% reduction in the 40% rate of ≥ grade 2 treatment-related preoperative GI AEs from the conventional radiotherapy / capecitabine /oxaliplatin arm of study RTOG-0247 (NCT00081289) with 80% power and a one-sided type I error rate of 0.10.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.93
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Proportion (reported as percentage)
Estimated Value 51
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Number of Patients in Protocol Adherence Categories for Intensity-modulated Radiotherapy (IMRT) Planning
Hide Description Real-time quality assurance was performed remotely by the study chair or the radiation oncology co-chair prior to initiation of treatment for the first 40 cases. The final cases enrolled were reviewed within 3 months after accrual was completed. Review included evaluation of clinical target volume (CTV) and planning target volume (PTV), Organs at Risk (OARs), and treatment plan dosimetry.
Time Frame Pretreatment
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients who started study treatment
Arm/Group Title IMRT + Chemotherapy , Resection, Postoperative Chemotherapy
Hide Arm/Group Description:
Radiation therapy (intensity modulated radiation therapy [IMRT] + three dimensional conformal radiation therapy [3D-CRT]) + neoadjuvant chemotherapy (capecitabine and oxaliplatin) followed by resection and postoperative chemotherapy (FOLFOX)
Overall Number of Participants Analyzed 68
Measure Type: Count of Participants
Unit of Measure: Participants
Tumor volume: Contouring score Per Protocol
58
  85.3%
Acceptable variation
5
   7.4%
Unacceptable variation
5
   7.4%
Organs at risk: Contouring score Per Protocol
62
  91.2%
Acceptable variation
6
   8.8%
Unacceptable variation
0
   0.0%
Tumor volume: Dose volume analysis score Per Protocol
59
  86.8%
Acceptable variation
8
  11.8%
Unacceptable variation
1
   1.5%
Organs at risk: Dose volume analysis score Per Protocol
48
  70.6%
Acceptable variation
17
  25.0%
Unacceptable variation
3
   4.4%
3.Secondary Outcome
Title Number of Patients With Pathologic Complete Response
Hide Description Pathologic complete response is defined as no evidence of residual cancer histologically in the resection specimen.
Time Frame At the time of surgery, which is 4-8 weeks after radiation therapy, approximately 9-13 weeks from treatment start.
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients who started study treatment
Arm/Group Title IMRT + Chemotherapy , Resection, Postoperative Chemotherapy
Hide Arm/Group Description:
Radiation therapy (intensity modulated radiation therapy [IMRT] + three dimensional conformal radiation therapy [3D-CRT]) + neoadjuvant chemotherapy (capecitabine and oxaliplatin) followed by resection and postoperative chemotherapy (FOLFOX)
Overall Number of Participants Analyzed 68
Measure Type: Count of Participants
Unit of Measure: Participants
10
  14.7%
4.Secondary Outcome
Title Percentage of Patients With Grade 3 or Higher Treatment-related Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v3.0
Hide Description Grade refers to the severity of the adverse event (AE). The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE. Adverse events were compiled in four different time periods: 1) Preoperative: Preoperatively or, if no surgery, then ≤ 90 days from the Start of Concurrent Treatment; 2) Postoperative#1: Postoperatively and ≤ 30 days from the Date of Surgery; 3) Postoperative#2: Postoperatively and ≤ 90 days from the End of Postoperative Chemotherapy; 4) Overall: From start of concurrent treatment to end of follow-up;
Time Frame From study registration to end of follow-up. Maximum follow-up at time of analysis was 5.2 years.
Hide Outcome Measure Data
Hide Analysis Population Description
For the four time periods reported, respectively: all registered patients; patients that had surgery; patients that had surgery and postoperative chemotherapy; all registered patients.
Arm/Group Title IMRT + Chemotherapy , Resection, Postoperative Chemotherapy
Hide Arm/Group Description:
Radiation therapy (intensity modulated radiation therapy [IMRT] + three dimensional conformal radiation therapy [3D-CRT]) + neoadjuvant chemotherapy (capecitabine and oxaliplatin) followed by resection and postoperative chemotherapy (FOLFOX)
Overall Number of Participants Analyzed 68
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Preoperative Number Analyzed 68 participants
49
(37 to 60)
Postoperative #1 Number Analyzed 67 participants
7
(3 to 17)
Postoperative #2 Number Analyzed 42 participants
74
(59 to 85)
Overall Number Analyzed 68 participants
78
(67 to 86)
5.Secondary Outcome
Title Local-regional Failure: 4-year Rate
Hide Description Local failure is defined as: (1) any recurrence or surgery to the primary site after a complete response (CR) reported at surgery or reported after the end of protocol treatment; or (2) persistence [failure at one day post study entry], absence of CR after protocol treatment was completed and patient lived at least 90 days from the end of treatment. Regional failure is defined as: (1) any recurrence after a nodal CR reported at surgery or reported after the end of protocol treatment; or (2) persistence, absence of nodal CR after protocol treatment was completed and patient lived at least 90 days from the end of treatment. Local-regional failure time is defined as time from registration to local or regional failure, last known follow-up (censored), or death (competing risk). Local-regional failure rates are estimated by the cumulative incidence method.
Time Frame From registration to four years
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients who started study treatment
Arm/Group Title IMRT + Chemotherapy , Resection, Postoperative Chemotherapy
Hide Arm/Group Description:
Radiation therapy (intensity modulated radiation therapy [IMRT] + three dimensional conformal radiation therapy [3D-CRT]) + neoadjuvant chemotherapy (capecitabine and oxaliplatin) followed by resection and postoperative chemotherapy (FOLFOX)
Overall Number of Participants Analyzed 68
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
7.4
(1.0 to 13.7)
6.Secondary Outcome
Title Distant Failure: 4-year Rate
Hide Description Distant failure is defined as the appearance of peritoneal seeding or distant metastases. Time to distant failure is defined as time from registration to the date of distant failure, last known follow-up (censored), or death (competing risk). Distant failure rates are estimated by the cumulative incidence method.
Time Frame From registration to four years
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients who started study treatment
Arm/Group Title IMRT + Chemotherapy , Resection, Postoperative Chemotherapy
Hide Arm/Group Description:
Radiation therapy (intensity modulated radiation therapy [IMRT] + three dimensional conformal radiation therapy [3D-CRT]) + neoadjuvant chemotherapy (capecitabine and oxaliplatin) followed by resection and postoperative chemotherapy (FOLFOX)
Overall Number of Participants Analyzed 68
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
29.7
(18.7 to 40.8)
7.Secondary Outcome
Title Overall Survival: 4-year Rate
Hide Description Overall survival time is defined as time from registration to the date of death from any cause. Overall survival rates are estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact.
Time Frame From registration to four years
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients who started study treatment
Arm/Group Title IMRT + Chemotherapy , Resection, Postoperative Chemotherapy
Hide Arm/Group Description:
Radiation therapy (intensity modulated radiation therapy [IMRT] + three dimensional conformal radiation therapy [3D-CRT]) + neoadjuvant chemotherapy (capecitabine and oxaliplatin) followed by resection and postoperative chemotherapy (FOLFOX)
Overall Number of Participants Analyzed 68
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
82.9
(70.1 to 90.6)
8.Secondary Outcome
Title Disease-free Survival: 4-year Rate
Hide Description Disease is defined as local-regional failure or distant failure. Distant failure is defined as the appearance of peritoneal seeding or distant metastases. Local-regional failure is defined as: (1) any recurrence or surgery to the primary site after a complete response (CR) / any recurrence after a nodal CR - reported at surgery or reported after the end of protocol treatment; or (2) persistence [failure at one day post study entry], absence of primary/nodal CR after protocol treatment was completed and patient lived at least 90 days from the end of treatment. Disease-free survival time is defined as time from registration to the date of disease, death, or last known follow-up (censored). Disease-free survival rates are estimated using the Kaplan-Meier method.
Time Frame From registration to four years
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients who started study treatment
Arm/Group Title IMRT + Chemotherapy , Resection, Postoperative Chemotherapy
Hide Arm/Group Description:
Radiation therapy (intensity modulated radiation therapy [IMRT] + three dimensional conformal radiation therapy [3D-CRT]) + neoadjuvant chemotherapy (capecitabine and oxaliplatin) followed by resection and postoperative chemotherapy (FOLFOX)
Overall Number of Participants Analyzed 68
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
60.6
(47.5 to 71.4)
9.Secondary Outcome
Title Number of Patients Who Underwent Abdominoperineal Resection
Hide Description All patients were to undergo surgery 4 to 8 weeks following the completion of radiation therapy. The choice of procedure (abdominoperineal resection (APR), low anterior resection (LAR), or LAR/coloanal anastomosis) was at the discretion of the surgeon. If more than 28 patients received abdominoperineal resection, this would result in a conclusion of an excessive number of abdominoperineal resections.
Time Frame Surgery occurred 4 to 8 weeks following the completion of radiation therapy, approximately 9-13 weeks from start of treatment.
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients that had surgery
Arm/Group Title IMRT + Chemotherapy , Resection, Postoperative Chemotherapy
Hide Arm/Group Description:
Radiation therapy (intensity modulated radiation therapy [IMRT] + three dimensional conformal radiation therapy [3D-CRT]) + neoadjuvant chemotherapy (capecitabine and oxaliplatin) followed by resection and postoperative chemotherapy (FOLFOX)
Overall Number of Participants Analyzed 67
Measure Type: Count of Participants
Unit of Measure: Participants
14
  20.9%
Time Frame [Not Specified]
Adverse Event Reporting Description Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
 
Arm/Group Title IMRT + Chemotherapy , Resection, Postoperative Chemotherapy
Hide Arm/Group Description Radiation therapy (intensity modulated radiation therapy [IMRT] + three dimensional conformal radiation therapy [3D-CRT]) + neoadjuvant chemotherapy (capecitabine and oxaliplatin) followed by resection and postoperative chemotherapy (FOLFOX)
All-Cause Mortality
IMRT + Chemotherapy , Resection, Postoperative Chemotherapy
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
IMRT + Chemotherapy , Resection, Postoperative Chemotherapy
Affected / at Risk (%)
Total   23/68 (33.82%) 
Blood and lymphatic system disorders   
Hemoglobin decreased * 1  4/68 (5.88%) 
Cardiac disorders   
Atrial fibrillation * 1  1/68 (1.47%) 
Atrial tachycardia * 1  1/68 (1.47%) 
Myocardial ischemia * 1  1/68 (1.47%) 
Sinus tachycardia * 1  1/68 (1.47%) 
Gastrointestinal disorders   
Abdominal pain * 1  2/68 (2.94%) 
Colonic stenosis * 1  1/68 (1.47%) 
Diarrhea * 1  10/68 (14.71%) 
Dyspepsia * 1  1/68 (1.47%) 
Dysphagia * 1  1/68 (1.47%) 
Enteritis * 1  1/68 (1.47%) 
Esophageal hemorrhage * 1  1/68 (1.47%) 
Esophagitis * 1  1/68 (1.47%) 
Gastrointestinal disorder * 1  1/68 (1.47%) 
Ileus * 1  1/68 (1.47%) 
Mucositis oral * 1  1/68 (1.47%) 
Nausea * 1  3/68 (4.41%) 
Rectal hemorrhage * 1  1/68 (1.47%) 
Rectal pain * 1  1/68 (1.47%) 
Small intestinal obstruction * 1  2/68 (2.94%) 
Vomiting * 1  3/68 (4.41%) 
General disorders   
Fatigue * 1  3/68 (4.41%) 
Fever * 1  2/68 (2.94%) 
Pain * 1  1/68 (1.47%) 
Infections and infestations   
Peritoneal infection * 1  1/68 (1.47%) 
Pneumonia * 1  1/68 (1.47%) 
Sepsis * 1  3/68 (4.41%) 
Injury, poisoning and procedural complications   
Intraoperative complications * 1  1/68 (1.47%) 
Rectal anastomotic leak * 1  1/68 (1.47%) 
Wound dehiscence * 1  1/68 (1.47%) 
Investigations   
Alkaline phosphatase increased * 1  1/68 (1.47%) 
Aspartate aminotransferase increased * 1  1/68 (1.47%) 
Creatinine increased * 1  1/68 (1.47%) 
Leukopenia * 1  5/68 (7.35%) 
Lymphopenia * 1  2/68 (2.94%) 
Neutrophil count decreased * 1  4/68 (5.88%) 
Platelet count decreased * 1  1/68 (1.47%) 
Metabolism and nutrition disorders   
Anorexia * 1  1/68 (1.47%) 
Dehydration * 1  5/68 (7.35%) 
Hyperglycemia * 1  2/68 (2.94%) 
Hypermagnesemia * 1  1/68 (1.47%) 
Hypoalbuminemia * 1  2/68 (2.94%) 
Hypocalcemia * 1  2/68 (2.94%) 
Hypokalemia * 1  4/68 (5.88%) 
Hypomagnesemia * 1  1/68 (1.47%) 
Hyponatremia * 1  4/68 (5.88%) 
Nervous system disorders   
Dizziness * 1  1/68 (1.47%) 
Ischemia cerebrovascular * 1  1/68 (1.47%) 
Peripheral sensory neuropathy * 1  1/68 (1.47%) 
Psychiatric disorders   
Insomnia * 1  1/68 (1.47%) 
Renal and urinary disorders   
Renal failure * 1  1/68 (1.47%) 
Ureteric obstruction * 1  1/68 (1.47%) 
Urinary incontinence * 1  1/68 (1.47%) 
Reproductive system and breast disorders   
Pelvic pain * 1  1/68 (1.47%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnea * 1  1/68 (1.47%) 
Hypoxia * 1  1/68 (1.47%) 
Pneumonitis * 1  1/68 (1.47%) 
Skin and subcutaneous tissue disorders   
Pruritus * 1  1/68 (1.47%) 
Rash desquamating * 1  1/68 (1.47%) 
Sweating * 1  1/68 (1.47%) 
Urticaria * 1  1/68 (1.47%) 
Vascular disorders   
Hypertension * 1  1/68 (1.47%) 
Thrombosis * 1  4/68 (5.88%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
IMRT + Chemotherapy , Resection, Postoperative Chemotherapy
Affected / at Risk (%)
Total   67/68 (98.53%) 
Blood and lymphatic system disorders   
Blood disorder * 1  5/68 (7.35%) 
Hemoglobin decreased * 1  40/68 (58.82%) 
Eye disorders   
Vision blurred * 1  4/68 (5.88%) 
Gastrointestinal disorders   
Abdominal distension * 1  5/68 (7.35%) 
Abdominal pain * 1  25/68 (36.76%) 
Anal pain * 1  10/68 (14.71%) 
Constipation * 1  31/68 (45.59%) 
Diarrhea * 1  55/68 (80.88%) 
Dyspepsia * 1  9/68 (13.24%) 
Dysphagia * 1  7/68 (10.29%) 
Fecal incontinence * 1  6/68 (8.82%) 
Flatulence * 1  4/68 (5.88%) 
Gastrointestinal disorder * 1  11/68 (16.18%) 
Mucositis oral * 1  12/68 (17.65%) 
Nausea * 1  48/68 (70.59%) 
Proctitis * 1  7/68 (10.29%) 
Rectal fistula * 1  4/68 (5.88%) 
Rectal hemorrhage * 1  9/68 (13.24%) 
Rectal pain * 1  27/68 (39.71%) 
Vomiting * 1  25/68 (36.76%) 
General disorders   
Chest pain * 1  8/68 (11.76%) 
Chills * 1  5/68 (7.35%) 
Edema limbs * 1  8/68 (11.76%) 
Fatigue * 1  54/68 (79.41%) 
Fever * 1  10/68 (14.71%) 
Pain * 1  12/68 (17.65%) 
Immune system disorders   
Hypersensitivity * 1  5/68 (7.35%) 
Injury, poisoning and procedural complications   
Dermatitis radiation * 1  13/68 (19.12%) 
Radiation recall reaction (dermatologic) * 1  12/68 (17.65%) 
Vascular access complication * 1  4/68 (5.88%) 
Wound dehiscence * 1  6/68 (8.82%) 
Investigations   
Alanine aminotransferase increased * 1  24/68 (35.29%) 
Alkaline phosphatase increased * 1  17/68 (25.00%) 
Aspartate aminotransferase increased * 1  23/68 (33.82%) 
Creatinine increased * 1  6/68 (8.82%) 
Hyperbilirubinemia * 1  11/68 (16.18%) 
Laboratory test abnormal * 1  6/68 (8.82%) 
Leukopenia * 1  41/68 (60.29%) 
Lymphopenia * 1  23/68 (33.82%) 
Neutrophil count decreased * 1  34/68 (50.00%) 
Platelet count decreased * 1  34/68 (50.00%) 
Weight loss * 1  18/68 (26.47%) 
Metabolism and nutrition disorders   
Anorexia * 1  27/68 (39.71%) 
Dehydration * 1  18/68 (26.47%) 
Hyperglycemia * 1  35/68 (51.47%) 
Hyperkalemia * 1  7/68 (10.29%) 
Hypoalbuminemia * 1  16/68 (23.53%) 
Hypocalcemia * 1  20/68 (29.41%) 
Hypokalemia * 1  17/68 (25.00%) 
Hypomagnesemia * 1  8/68 (11.76%) 
Hyponatremia * 1  18/68 (26.47%) 
Musculoskeletal and connective tissue disorders   
Back pain * 1  10/68 (14.71%) 
Bone pain * 1  5/68 (7.35%) 
Joint pain * 1  5/68 (7.35%) 
Muscle weakness * 1  6/68 (8.82%) 
Neck pain * 1  4/68 (5.88%) 
Pain in extremity * 1  8/68 (11.76%) 
Nervous system disorders   
Dizziness * 1  6/68 (8.82%) 
Headache * 1  13/68 (19.12%) 
Neurological disorder NOS * 1  5/68 (7.35%) 
Peripheral motor neuropathy * 1  8/68 (11.76%) 
Peripheral sensory neuropathy * 1  50/68 (73.53%) 
Taste alteration * 1  15/68 (22.06%) 
Psychiatric disorders   
Agitation * 1  5/68 (7.35%) 
Anxiety * 1  9/68 (13.24%) 
Depression * 1  10/68 (14.71%) 
Insomnia * 1  22/68 (32.35%) 
Renal and urinary disorders   
Cystitis * 1  6/68 (8.82%) 
Urinary frequency * 1  13/68 (19.12%) 
Urinary incontinence * 1  4/68 (5.88%) 
Respiratory, thoracic and mediastinal disorders   
Cough * 1  12/68 (17.65%) 
Dyspnea * 1  11/68 (16.18%) 
Hemorrhage nasal * 1  6/68 (8.82%) 
Skin and subcutaneous tissue disorders   
Alopecia * 1  14/68 (20.59%) 
Dry skin * 1  8/68 (11.76%) 
Hand-and-foot syndrome * 1  12/68 (17.65%) 
Rash desquamating * 1  10/68 (14.71%) 
Skin disorder * 1  5/68 (7.35%) 
Sweating * 1  6/68 (8.82%) 
Vascular disorders   
Hot flashes * 1  6/68 (8.82%) 
Hypotension * 1  5/68 (7.35%) 
Thrombosis * 1  6/68 (8.82%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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: Wendy Seiferheld
Organization: Radiation Therapy Oncology Group (RTOG)
EMail: wseiferheld@acr.com
Layout table for additonal information
Responsible Party: Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier: NCT00613080     History of Changes
Other Study ID Numbers: RTOG-0822
CDR0000586277
First Submitted: February 9, 2008
First Posted: February 12, 2008
Results First Submitted: April 12, 2013
Results First Posted: June 10, 2013
Last Update Posted: September 25, 2018