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Trial record 9 of 125 for:    colon cancer AND Rectal | ( Map: New Jersey, United States )

Neoadjuvant Chemoradiotherapy and Adjuvant Chemotherapy in Treating Patients Who Are Undergoing Surgical Resection for Locally Advanced Rectal 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: NCT00081289
Recruitment Status : Completed
First Posted : April 8, 2004
Results First Posted : November 25, 2013
Last Update Posted : February 17, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Radiation Therapy Oncology Group

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Colorectal Cancer
Interventions Radiation: Radiation Therapy
Drug: Capecitabine 1650 mg/m^2/day
Drug: Capecitabine 1200 mg/m^2/day
Drug: Irinotecan
Drug: Oxaliplatin
Procedure: Surgery
Drug: Folinic Acid
Drug: Fluorouracil
Enrollment 146
Recruitment Details  
Pre-assignment Details The study was temporarily closed to accrual after the first 35 patients due to excessive GI adverse events (AEs). The protocol was amended and the study reopened (treatment descriptions reflect the revision). Since changes were made to the treatment regimens, the first 35 patients will not be used to answer the primary endpoint question.
Arm/Group Title Neoadjuvant Chemoradiation With Irinotecan Neoadjuvant Chemoradiation With Oxaliplatin
Hide Arm/Group Description Patients receive neoadjuvant therapy comprising radiotherapy (RT), 1200mg/m2/day oral capecitabine and irinotecan. Surgery 4-8 weeks after RT. Postoperative chemotherapy (folinic acid, fluorouracil, and oxaliplatin) 4-6 weeks after surgery. Patients receive neoadjuvant therapy comprising radiotherapy, 1650mg/m2/day oral capecitabine and oxaliplatin. Surgery 4-8 weeks after RT. Postoperative chemotherapy (folinic acid, fluorouracil, and oxaliplatin) 4-6 weeks after surgery.
Period Title: Overall Study
Started 73 73
Completed 52 [1] 52
Not Completed 21 21
Reason Not Completed
Accrued prior to chemotherapy amendment             18             17
Ineligible / no protocol treatment             3             4
[1]
Subjects contributing data to the primary analysis are considered to have completed the study.
Arm/Group Title Neoadjuvant Chemoradiation With Irinotecan Neoadjuvant Chemoradiation With Oxaliplatin Total
Hide Arm/Group Description Patients receive neoadjuvant therapy comprising radiotherapy, 1200mg/m2/day oral capecitabine and irinotecan. Surgery 4-8 weeks after RT. Postoperative chemotherapy (folinic acid, fluorouracil, and oxaliplatin) 4-6 weeks after surgery. Patients receive neoadjuvant therapy comprising radiotherapy, 1650mg/m2/day oral capecitabine and oxaliplatin. Surgery 4-8 weeks after RT. Postoperative chemotherapy (folinic acid, fluorouracil, and oxaliplatin) 4-6 weeks after surgery. Total of all reporting groups
Overall Number of Baseline Participants 52 52 104
Hide Baseline Analysis Population Description
All eligible patients enrolled after the protocol ammendment.
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 52 participants 52 participants 104 participants
57
(27 to 78)
56
(30 to 76)
57
(27 to 78)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 52 participants 52 participants 104 participants
Female
19
  36.5%
14
  26.9%
33
  31.7%
Male
33
  63.5%
38
  73.1%
71
  68.3%
1.Primary Outcome
Title Pathologic Complete Response Rate
Hide Description

A pathologic complete response (pCR) was defined as no evidence of residual cancer histologically; disease progression or death before surgery was considered less than pCR (even without surgical specimen). All cases were reviewed by the study’s surgical oncology co-chair for the determination of pCR.

Each arm was first analyzed alone. If the arm had 9 or more pCRs in 48 evaluable pts, then the null hypothesis (H0) of 10% pCR rate would be rejected in favor of the alternative hypothesis of 25%, providing 90% power with a two-sided 10% type I error rate. If both arms reject H0, then statistical selection theory would be used to choose the arm for further study in a phase III trial. If only one arm has acceptable pCR rate, then that arm would be pursued in a phase III trial.

Time Frame After protocol surgery
Hide Outcome Measure Data
Hide Analysis Population Description
For each arm the first 48 eligible enrolled after the protocol amendment.
Arm/Group Title Neoadjuvant Chemoradiation With Irinotecan Neoadjuvant Chemoradiation With Oxaliplatin
Hide Arm/Group Description:
Patients receive neoadjuvant therapy comprising radiotherapy, 1200mg/m2/day oral capecitabine and irinotecan. Surgery 4-8 weeks after RT. Postoperative chemotherapy (folinic acid, fluorouracil, and oxaliplatin) 4-6 weeks after surgery.
Patients receive neoadjuvant therapy comprising radiotherapy, 1650mg/m2/day oral capecitabine and oxaliplatin. Surgery 4-8 weeks after RT. Postoperative chemotherapy (folinic acid, fluorouracil, and oxaliplatin) 4-6 weeks after surgery.
Overall Number of Participants Analyzed 48 48
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
10.4
(3.5 to 22.7)
20.8
(10.5 to 35.0)
2.Secondary Outcome
Title Time to Treatment Failure and Patterns of Failure
Hide Description [Not Specified]
Time Frame From randomization to date of local failure, regional failure, distant failure, death or last follow-up. Analysis occurs after all patients have been potentially followed for 12 months.
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Incidence of Hematologic and Non-hematologic Grade 3-4 Toxicity (Preoperatively, Postoperatively, and Overall)
Hide Description [Not Specified]
Time Frame Three time frames: start of treatment to surgery, surgery to end of follow-up, and combined.
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Tumor Marker Evaluation Using Preoperative Tissue Biopsy Specimens and Surgically Resected Tissue Specimens
Hide Description [Not Specified]
Time Frame End of study
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Quality of Life as Assessed After Completion of Chemoradiotherapy and Adjuvant Chemotherapy and Then at 2 Years
Hide Description [Not Specified]
Time Frame From randomization to 3 timepoints: 1) completion of chemoradiation, 2) completion of post-operative chemotherapy (approximately 1 year), and 3) two years
Outcome Measure Data Not Reported
Time Frame The study was temporarily closed to accrual due to excessive GI AEs in the first 35 patients. Chemotherapy was adjusted, protocol amended, and the study reopened (treatment descriptions reflect the revision). AEs are reported for all eligible patients.
Adverse Event Reporting Description Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
 
Arm/Group Title Neoadjuvant Chemoradiation With Irinotecan Neoadjuvant Chemoradiation With Oxaliplatin
Hide Arm/Group Description Patients receive neoadjuvant therapy comprising radiotherapy, 1200mg/m2/day oral capecitabine and irinotecan. Surgery 4-8 weeks after RT. Postoperative chemotherapy (folinic acid, fluorouracil, and oxaliplatin) 4-6 weeks after surgery. Patients receive neoadjuvant therapy comprising radiotherapy, 1650mg/m2/day oral capecitabine and oxaliplatin. Surgery 4-8 weeks after RT. Postoperative chemotherapy (folinic acid, fluorouracil, and oxaliplatin) 4-6 weeks after surgery.
All-Cause Mortality
Neoadjuvant Chemoradiation With Irinotecan Neoadjuvant Chemoradiation With Oxaliplatin
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Neoadjuvant Chemoradiation With Irinotecan Neoadjuvant Chemoradiation With Oxaliplatin
Affected / at Risk (%) Affected / at Risk (%)
Total   35/70 (50.00%)   33/69 (47.83%) 
Blood and lymphatic system disorders     
Anemia * 1  7/70 (10.00%)  7/69 (10.14%) 
Blood and lymphatic system disorders - Other * 1  0/70 (0.00%)  1/69 (1.45%) 
Cardiac disorders     
Atrial fibrillation * 1  1/70 (1.43%)  0/69 (0.00%) 
Chest pain - cardiac * 1  1/70 (1.43%)  0/69 (0.00%) 
Heart failure * 1  1/70 (1.43%)  0/69 (0.00%) 
Sinus tachycardia * 1  0/70 (0.00%)  1/69 (1.45%) 
Supraventricular tachycardia * 1  0/70 (0.00%)  1/69 (1.45%) 
Gastrointestinal disorders     
Abdominal distension * 1  0/70 (0.00%)  1/69 (1.45%) 
Abdominal pain * 1  3/70 (4.29%)  3/69 (4.35%) 
Colitis * 1  0/70 (0.00%)  2/69 (2.90%) 
Colonic obstruction * 1  1/70 (1.43%)  0/69 (0.00%) 
Constipation * 1  1/70 (1.43%)  1/69 (1.45%) 
Diarrhea * 1  12/70 (17.14%)  15/69 (21.74%) 
Dry mouth * 1  0/70 (0.00%)  1/69 (1.45%) 
Duodenal ulcer * 1  1/70 (1.43%)  0/69 (0.00%) 
Dyspepsia * 1  1/70 (1.43%)  0/69 (0.00%) 
Enterocolitis * 1  1/70 (1.43%)  1/69 (1.45%) 
Gastrointestinal disorders - Other * 1  1/70 (1.43%)  2/69 (2.90%) 
Hemorrhoids * 1  0/70 (0.00%)  1/69 (1.45%) 
Nausea * 1  4/70 (5.71%)  5/69 (7.25%) 
Proctitis * 1  0/70 (0.00%)  3/69 (4.35%) 
Rectal fistula * 1  1/70 (1.43%)  0/69 (0.00%) 
Rectal hemorrhage * 1  0/70 (0.00%)  2/69 (2.90%) 
Rectal pain * 1  2/70 (2.86%)  3/69 (4.35%) 
Rectal stenosis * 1  0/70 (0.00%)  1/69 (1.45%) 
Rectal ulcer * 1  0/70 (0.00%)  1/69 (1.45%) 
Small intestinal obstruction * 1  3/70 (4.29%)  4/69 (5.80%) 
Tooth development disorder * 1  0/70 (0.00%)  1/69 (1.45%) 
Vomiting * 1  3/70 (4.29%)  6/69 (8.70%) 
General disorders     
Chills * 1  1/70 (1.43%)  1/69 (1.45%) 
Death NOS * 1  0/70 (0.00%)  1/69 (1.45%) 
Fatigue * 1  4/70 (5.71%)  6/69 (8.70%) 
Fever * 1  2/70 (2.86%)  3/69 (4.35%) 
Multi-organ failure * 1  1/70 (1.43%)  0/69 (0.00%) 
Non-cardiac chest pain * 1  1/70 (1.43%)  0/69 (0.00%) 
Pain * 1  1/70 (1.43%)  0/69 (0.00%) 
Sudden death NOS * 1  0/70 (0.00%)  1/69 (1.45%) 
Infections and infestations     
Anorectal infection * 1  0/70 (0.00%)  1/69 (1.45%) 
Bladder infection * 1  0/70 (0.00%)  1/69 (1.45%) 
Infections and infestations - Other * 1  4/70 (5.71%)  6/69 (8.70%) 
Lung infection * 1  0/70 (0.00%)  1/69 (1.45%) 
Pelvic infection * 1  0/70 (0.00%)  1/69 (1.45%) 
Wound infection * 1  1/70 (1.43%)  1/69 (1.45%) 
Injury, poisoning and procedural complications     
Dermatitis radiation * 1  0/70 (0.00%)  3/69 (4.35%) 
Radiation recall reaction (dermatologic) * 1  0/70 (0.00%)  1/69 (1.45%) 
Small intestinal anastomotic leak * 1  0/70 (0.00%)  1/69 (1.45%) 
Investigations     
Alkaline phosphatase increased * 1  1/70 (1.43%)  0/69 (0.00%) 
Creatinine increased * 1  1/70 (1.43%)  2/69 (2.90%) 
Investigations - Other * 1  0/70 (0.00%)  2/69 (2.90%) 
Lymphocyte count decreased * 1  0/70 (0.00%)  1/69 (1.45%) 
Neutrophil count decreased * 1  3/70 (4.29%)  1/69 (1.45%) 
Platelet count decreased * 1  2/70 (2.86%)  3/69 (4.35%) 
Weight loss * 1  1/70 (1.43%)  3/69 (4.35%) 
White blood cell decreased * 1  8/70 (11.43%)  5/69 (7.25%) 
Metabolism and nutrition disorders     
Alkalosis * 1  0/70 (0.00%)  1/69 (1.45%) 
Dehydration * 1  11/70 (15.71%)  7/69 (10.14%) 
Hyperglycemia * 1  1/70 (1.43%)  3/69 (4.35%) 
Hyperkalemia * 1  0/70 (0.00%)  1/69 (1.45%) 
Hypermagnesemia * 1  1/70 (1.43%)  0/69 (0.00%) 
Hyperuricemia * 1  0/70 (0.00%)  1/69 (1.45%) 
Hypoalbuminemia * 1  1/70 (1.43%)  3/69 (4.35%) 
Hypocalcemia * 1  2/70 (2.86%)  2/69 (2.90%) 
Hypokalemia * 1  2/70 (2.86%)  4/69 (5.80%) 
Hypomagnesemia * 1  0/70 (0.00%)  1/69 (1.45%) 
Hyponatremia * 1  2/70 (2.86%)  0/69 (0.00%) 
Musculoskeletal and connective tissue disorders     
Arthritis * 1  0/70 (0.00%)  1/69 (1.45%) 
Generalized muscle weakness * 1  1/70 (1.43%)  0/69 (0.00%) 
Musculoskeletal and connective tissue disorder - Other * 1  0/70 (0.00%)  1/69 (1.45%) 
Pain in extremity * 1  1/70 (1.43%)  0/69 (0.00%) 
Nervous system disorders     
Dizziness * 1  1/70 (1.43%)  1/69 (1.45%) 
Dysgeusia * 1  0/70 (0.00%)  1/69 (1.45%) 
Ischemia cerebrovascular * 1  0/70 (0.00%)  1/69 (1.45%) 
Peripheral sensory neuropathy * 1  2/70 (2.86%)  1/69 (1.45%) 
Tremor * 1  1/70 (1.43%)  0/69 (0.00%) 
Vasovagal reaction * 1  0/70 (0.00%)  1/69 (1.45%) 
Psychiatric disorders     
Confusion * 1  1/70 (1.43%)  0/69 (0.00%) 
Insomnia * 1  1/70 (1.43%)  0/69 (0.00%) 
Renal and urinary disorders     
Acute kidney injury * 1  0/70 (0.00%)  2/69 (2.90%) 
Renal and urinary disorders - Other * 1  0/70 (0.00%)  2/69 (2.90%) 
Urinary tract obstruction * 1  0/70 (0.00%)  1/69 (1.45%) 
Reproductive system and breast disorders     
Irregular menstruation * 1  0/70 (0.00%)  1/69 (1.45%) 
Pelvic pain * 1  0/70 (0.00%)  1/69 (1.45%) 
Testicular pain * 1  0/70 (0.00%)  1/69 (1.45%) 
Vaginal dryness * 1  1/70 (1.43%)  0/69 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnea * 1  2/70 (2.86%)  1/69 (1.45%) 
Pneumonitis * 1  0/70 (0.00%)  1/69 (1.45%) 
Skin and subcutaneous tissue disorders     
Hyperhidrosis * 1  1/70 (1.43%)  0/69 (0.00%) 
Pruritus * 1  0/70 (0.00%)  1/69 (1.45%) 
Rash acneiform * 1  0/70 (0.00%)  1/69 (1.45%) 
Rash maculo-papular * 1  2/70 (2.86%)  0/69 (0.00%) 
Skin ulceration * 1  0/70 (0.00%)  1/69 (1.45%) 
Vascular disorders     
Hypotension * 1  2/70 (2.86%)  2/69 (2.90%) 
Thromboembolic event * 1  2/70 (2.86%)  5/69 (7.25%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (4.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Neoadjuvant Chemoradiation With Irinotecan Neoadjuvant Chemoradiation With Oxaliplatin
Affected / at Risk (%) Affected / at Risk (%)
Total   70/70 (100.00%)   68/69 (98.55%) 
Blood and lymphatic system disorders     
Anemia * 1  49/70 (70.00%)  43/69 (62.32%) 
Blood and lymphatic system disorders - Other * 1  1/70 (1.43%)  6/69 (8.70%) 
Febrile neutropenia * 1  0/70 (0.00%)  1/69 (1.45%) 
Hemolysis * 1  1/70 (1.43%)  0/69 (0.00%) 
Cardiac disorders     
Atrial fibrillation * 1  1/70 (1.43%)  0/69 (0.00%) 
Cardiac disorders - Other * 1  1/70 (1.43%)  2/69 (2.90%) 
Chest pain - cardiac * 1  0/70 (0.00%)  1/69 (1.45%) 
Conduction disorder * 1  0/70 (0.00%)  1/69 (1.45%) 
Myocardial infarction * 1  0/70 (0.00%)  1/69 (1.45%) 
Palpitations * 1  1/70 (1.43%)  0/69 (0.00%) 
Pericardial effusion * 1  1/70 (1.43%)  0/69 (0.00%) 
Sinus tachycardia * 1  0/70 (0.00%)  1/69 (1.45%) 
Supraventricular tachycardia * 1  0/70 (0.00%)  1/69 (1.45%) 
Ventricular arrhythmia * 1  0/70 (0.00%)  1/69 (1.45%) 
Ear and labyrinth disorders     
Tinnitus * 1  1/70 (1.43%)  0/69 (0.00%) 
Endocrine disorders     
Endocrine disorders - Other * 1  0/70 (0.00%)  1/69 (1.45%) 
Eye disorders     
Blurred vision * 1  2/70 (2.86%)  2/69 (2.90%) 
Dry eye * 1  1/70 (1.43%)  1/69 (1.45%) 
Flashing lights * 1  0/70 (0.00%)  1/69 (1.45%) 
Gastrointestinal disorders     
Abdominal distension * 1  1/70 (1.43%)  3/69 (4.35%) 
Abdominal pain * 1  21/70 (30.00%)  16/69 (23.19%) 
Anal hemorrhage * 1  2/70 (2.86%)  0/69 (0.00%) 
Anal mucositis * 1  1/70 (1.43%)  1/69 (1.45%) 
Anal pain * 1  3/70 (4.29%)  1/69 (1.45%) 
Ascites * 1  1/70 (1.43%)  1/69 (1.45%) 
Colitis * 1  1/70 (1.43%)  2/69 (2.90%) 
Colonic obstruction * 1  0/70 (0.00%)  2/69 (2.90%) 
Colonic stenosis * 1  1/70 (1.43%)  0/69 (0.00%) 
Constipation * 1  24/70 (34.29%)  18/69 (26.09%) 
Dental caries * 1  0/70 (0.00%)  1/69 (1.45%) 
Diarrhea * 1  56/70 (80.00%)  57/69 (82.61%) 
Dry mouth * 1  2/70 (2.86%)  3/69 (4.35%) 
Dyspepsia * 1  8/70 (11.43%)  3/69 (4.35%) 
Dysphagia * 1  0/70 (0.00%)  3/69 (4.35%) 
Enterocolitis * 1  2/70 (2.86%)  2/69 (2.90%) 
Esophageal pain * 1  1/70 (1.43%)  0/69 (0.00%) 
Esophageal stenosis * 1  1/70 (1.43%)  0/69 (0.00%) 
Esophagitis * 1  1/70 (1.43%)  0/69 (0.00%) 
Fecal incontinence * 1  2/70 (2.86%)  6/69 (8.70%) 
Flatulence * 1  8/70 (11.43%)  4/69 (5.80%) 
Gastritis * 1  0/70 (0.00%)  1/69 (1.45%) 
Gastrointestinal disorders - Other * 1  6/70 (8.57%)  8/69 (11.59%) 
Hemorrhoids * 1  5/70 (7.14%)  3/69 (4.35%) 
Mucositis oral * 1  10/70 (14.29%)  10/69 (14.49%) 
Nausea * 1  39/70 (55.71%)  46/69 (66.67%) 
Oral pain * 1  0/70 (0.00%)  1/69 (1.45%) 
Proctitis * 1  10/70 (14.29%)  12/69 (17.39%) 
Rectal fistula * 1  0/70 (0.00%)  2/69 (2.90%) 
Rectal hemorrhage * 1  12/70 (17.14%)  6/69 (8.70%) 
Rectal mucositis * 1  3/70 (4.29%)  2/69 (2.90%) 
Rectal pain * 1  18/70 (25.71%)  22/69 (31.88%) 
Rectal stenosis * 1  1/70 (1.43%)  2/69 (2.90%) 
Small intestinal mucositis * 1  0/70 (0.00%)  1/69 (1.45%) 
Small intestinal obstruction * 1  0/70 (0.00%)  1/69 (1.45%) 
Stomach pain * 1  1/70 (1.43%)  0/69 (0.00%) 
Toothache * 1  1/70 (1.43%)  0/69 (0.00%) 
Vomiting * 1  19/70 (27.14%)  20/69 (28.99%) 
General disorders     
Chills * 1  3/70 (4.29%)  1/69 (1.45%) 
Death NOS * 1  0/70 (0.00%)  1/69 (1.45%) 
Edema face * 1  0/70 (0.00%)  1/69 (1.45%) 
Edema limbs * 1  3/70 (4.29%)  7/69 (10.14%) 
Edema trunk * 1  0/70 (0.00%)  1/69 (1.45%) 
Fatigue * 1  48/70 (68.57%)  52/69 (75.36%) 
Fever * 1  3/70 (4.29%)  6/69 (8.70%) 
General disorders and administration site conditions - Other * 1  3/70 (4.29%)  2/69 (2.90%) 
Injection site reaction * 1  1/70 (1.43%)  1/69 (1.45%) 
Localized edema * 1  1/70 (1.43%)  0/69 (0.00%) 
Multi-organ failure * 1  0/70 (0.00%)  1/69 (1.45%) 
Non-cardiac chest pain * 1  0/70 (0.00%)  2/69 (2.90%) 
Pain * 1  7/70 (10.00%)  6/69 (8.70%) 
Hepatobiliary disorders     
Hepatobiliary disorders - Other * 1  1/70 (1.43%)  1/69 (1.45%) 
Immune system disorders     
Allergic reaction * 1  0/70 (0.00%)  3/69 (4.35%) 
Infections and infestations     
Anorectal infection * 1  5/70 (7.14%)  1/69 (1.45%) 
Bladder infection * 1  0/70 (0.00%)  2/69 (2.90%) 
Bronchial infection * 1  0/70 (0.00%)  1/69 (1.45%) 
Catheter related infection * 1  0/70 (0.00%)  1/69 (1.45%) 
Gum infection * 1  2/70 (2.86%)  0/69 (0.00%) 
Infections and infestations - Other * 1  6/70 (8.57%)  7/69 (10.14%) 
Lip infection * 1  1/70 (1.43%)  0/69 (0.00%) 
Lung infection * 1  1/70 (1.43%)  0/69 (0.00%) 
Otitis externa * 1  0/70 (0.00%)  1/69 (1.45%) 
Pelvic infection * 1  0/70 (0.00%)  1/69 (1.45%) 
Penile infection * 1  1/70 (1.43%)  0/69 (0.00%) 
Peripheral nerve infection * 1  1/70 (1.43%)  0/69 (0.00%) 
Scrotal infection * 1  2/70 (2.86%)  0/69 (0.00%) 
Sinusitis * 1  0/70 (0.00%)  1/69 (1.45%) 
Skin infection * 1  1/70 (1.43%)  0/69 (0.00%) 
Soft tissue infection * 1  0/70 (0.00%)  1/69 (1.45%) 
Tooth infection * 1  1/70 (1.43%)  1/69 (1.45%) 
Upper respiratory infection * 1  1/70 (1.43%)  0/69 (0.00%) 
Urinary tract infection * 1  1/70 (1.43%)  0/69 (0.00%) 
Vaginal infection * 1  0/70 (0.00%)  1/69 (1.45%) 
Wound infection * 1  3/70 (4.29%)  1/69 (1.45%) 
Injury, poisoning and procedural complications     
Bruising * 1  1/70 (1.43%)  0/69 (0.00%) 
Burn * 1  1/70 (1.43%)  0/69 (0.00%) 
Dermatitis radiation * 1  17/70 (24.29%)  14/69 (20.29%) 
Fracture * 1  0/70 (0.00%)  1/69 (1.45%) 
Injury, poisoning and procedural complications - Other * 1  0/70 (0.00%)  1/69 (1.45%) 
Large intestinal anastomotic leak * 1  1/70 (1.43%)  0/69 (0.00%) 
Radiation recall reaction (dermatologic) * 1  4/70 (5.71%)  8/69 (11.59%) 
Vascular access complication * 1  0/70 (0.00%)  2/69 (2.90%) 
Venous injury * 1  0/70 (0.00%)  1/69 (1.45%) 
Wound dehiscence * 1  1/70 (1.43%)  2/69 (2.90%) 
Investigations     
Alanine aminotransferase increased * 1  17/70 (24.29%)  27/69 (39.13%) 
Alkaline phosphatase increased * 1  10/70 (14.29%)  20/69 (28.99%) 
Aspartate aminotransferase increased * 1  16/70 (22.86%)  25/69 (36.23%) 
Blood bilirubin increased * 1  6/70 (8.57%)  3/69 (4.35%) 
Blood gonadotrophin abnormal * 1  0/70 (0.00%)  1/69 (1.45%) 
CPK increased * 1  1/70 (1.43%)  1/69 (1.45%) 
Cardiac troponin I increased * 1  0/70 (0.00%)  1/69 (1.45%) 
Cholesterol high * 1  1/70 (1.43%)  1/69 (1.45%) 
Creatinine increased * 1  7/70 (10.00%)  8/69 (11.59%) 
Haptoglobin decreased * 1  0/70 (0.00%)  1/69 (1.45%) 
INR increased * 1  2/70 (2.86%)  2/69 (2.90%) 
Investigations - Other * 1  6/70 (8.57%)  13/69 (18.84%) 
Lipase increased * 1  0/70 (0.00%)  1/69 (1.45%) 
Lymphocyte count decreased * 1  7/70 (10.00%)  6/69 (8.70%) 
Neutrophil count decreased * 1  32/70 (45.71%)  30/69 (43.48%) 
Platelet count decreased * 1  27/70 (38.57%)  28/69 (40.58%) 
Serum amylase increased * 1  0/70 (0.00%)  1/69 (1.45%) 
Weight gain * 1  1/70 (1.43%)  2/69 (2.90%) 
Weight loss * 1  16/70 (22.86%)  19/69 (27.54%) 
White blood cell decreased * 1  47/70 (67.14%)  40/69 (57.97%) 
Metabolism and nutrition disorders     
Acidosis * 1  4/70 (5.71%)  1/69 (1.45%) 
Alkalosis * 1  1/70 (1.43%)  0/69 (0.00%) 
Anorexia * 1  23/70 (32.86%)  21/69 (30.43%) 
Dehydration * 1  8/70 (11.43%)  17/69 (24.64%) 
Glucose intolerance * 1  1/70 (1.43%)  0/69 (0.00%) 
Hypercalcemia * 1  3/70 (4.29%)  2/69 (2.90%) 
Hyperglycemia * 1  37/70 (52.86%)  25/69 (36.23%) 
Hyperkalemia * 1  4/70 (5.71%)  7/69 (10.14%) 
Hypernatremia * 1  2/70 (2.86%)  0/69 (0.00%) 
Hypertriglyceridemia * 1  0/70 (0.00%)  1/69 (1.45%) 
Hyperuricemia * 1  1/70 (1.43%)  1/69 (1.45%) 
Hypoalbuminemia * 1  16/70 (22.86%)  24/69 (34.78%) 
Hypocalcemia * 1  15/70 (21.43%)  22/69 (31.88%) 
Hypoglycemia * 1  3/70 (4.29%)  2/69 (2.90%) 
Hypokalemia * 1  17/70 (24.29%)  24/69 (34.78%) 
Hypomagnesemia * 1  7/70 (10.00%)  7/69 (10.14%) 
Hyponatremia * 1  18/70 (25.71%)  25/69 (36.23%) 
Hypophosphatemia * 1  4/70 (5.71%)  2/69 (2.90%) 
Iron overload * 1  0/70 (0.00%)  1/69 (1.45%) 
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  6/70 (8.57%)  1/69 (1.45%) 
Arthritis * 1  0/70 (0.00%)  1/69 (1.45%) 
Back pain * 1  6/70 (8.57%)  3/69 (4.35%) 
Bone pain * 1  0/70 (0.00%)  2/69 (2.90%) 
Buttock pain * 1  2/70 (2.86%)  1/69 (1.45%) 
Chest wall pain * 1  1/70 (1.43%)  0/69 (0.00%) 
Generalized muscle weakness * 1  1/70 (1.43%)  3/69 (4.35%) 
Musculoskeletal and connective tissue disorder - Other * 1  0/70 (0.00%)  2/69 (2.90%) 
Myalgia * 1  5/70 (7.14%)  5/69 (7.25%) 
Myositis * 1  0/70 (0.00%)  1/69 (1.45%) 
Neck pain * 1  1/70 (1.43%)  1/69 (1.45%) 
Pain in extremity * 1  0/70 (0.00%)  4/69 (5.80%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Tumor pain * 1  0/70 (0.00%)  1/69 (1.45%) 
Nervous system disorders     
Acoustic nerve disorder NOS * 1  0/70 (0.00%)  1/69 (1.45%) 
Ataxia * 1  1/70 (1.43%)  0/69 (0.00%) 
Dizziness * 1  7/70 (10.00%)  1/69 (1.45%) 
Dysgeusia * 1  5/70 (7.14%)  10/69 (14.49%) 
Extrapyramidal disorder * 1  1/70 (1.43%)  0/69 (0.00%) 
Headache * 1  2/70 (2.86%)  3/69 (4.35%) 
Nervous system disorders - Other * 1  2/70 (2.86%)  1/69 (1.45%) 
Neuralgia * 1  0/70 (0.00%)  3/69 (4.35%) 
Peripheral motor neuropathy * 1  3/70 (4.29%)  3/69 (4.35%) 
Peripheral sensory neuropathy * 1  36/70 (51.43%)  45/69 (65.22%) 
Recurrent laryngeal nerve palsy * 1  0/70 (0.00%)  1/69 (1.45%) 
Syncope * 1  2/70 (2.86%)  0/69 (0.00%) 
Psychiatric disorders     
Anxiety * 1  4/70 (5.71%)  5/69 (7.25%) 
Confusion * 1  0/70 (0.00%)  3/69 (4.35%) 
Delayed orgasm * 1  0/70 (0.00%)  1/69 (1.45%) 
Depression * 1  7/70 (10.00%)  7/69 (10.14%) 
Insomnia * 1  5/70 (7.14%)  9/69 (13.04%) 
Libido decreased * 1  1/70 (1.43%)  0/69 (0.00%) 
Personality change * 1  0/70 (0.00%)  1/69 (1.45%) 
Renal and urinary disorders     
Acute kidney injury * 1  0/70 (0.00%)  1/69 (1.45%) 
Chronic kidney disease * 1  1/70 (1.43%)  0/69 (0.00%) 
Cystitis noninfective * 1  2/70 (2.86%)  2/69 (2.90%) 
Hematuria * 1  2/70 (2.86%)  0/69 (0.00%) 
Proteinuria * 1  0/70 (0.00%)  1/69 (1.45%) 
Renal and urinary disorders - Other * 1  5/70 (7.14%)  6/69 (8.70%) 
Urinary frequency * 1  14/70 (20.00%)  10/69 (14.49%) 
Urinary incontinence * 1  3/70 (4.29%)  3/69 (4.35%) 
Urinary retention * 1  6/70 (8.57%)  3/69 (4.35%) 
Urinary tract obstruction * 1  1/70 (1.43%)  1/69 (1.45%) 
Urinary tract pain * 1  7/70 (10.00%)  6/69 (8.70%) 
Reproductive system and breast disorders     
Ejaculation disorder * 1  1/70 (1.43%)  0/69 (0.00%) 
Erectile dysfunction * 1  3/70 (4.29%)  4/69 (5.80%) 
Pelvic pain * 1  1/70 (1.43%)  2/69 (2.90%) 
Penile pain * 1  0/70 (0.00%)  1/69 (1.45%) 
Perineal pain * 1  1/70 (1.43%)  2/69 (2.90%) 
Prostatic pain * 1  1/70 (1.43%)  0/69 (0.00%) 
Reproductive system and breast disorders - Other * 1  1/70 (1.43%)  0/69 (0.00%) 
Testicular pain * 1  0/70 (0.00%)  1/69 (1.45%) 
Uterine pain * 1  0/70 (0.00%)  1/69 (1.45%) 
Vaginal dryness * 1  1/70 (1.43%)  0/69 (0.00%) 
Vaginal hemorrhage * 1  1/70 (1.43%)  1/69 (1.45%) 
Vaginal pain * 1  0/70 (0.00%)  1/69 (1.45%) 
Respiratory, thoracic and mediastinal disorders     
Allergic rhinitis * 1  1/70 (1.43%)  0/69 (0.00%) 
Atelectasis * 1  0/70 (0.00%)  1/69 (1.45%) 
Cough * 1  4/70 (5.71%)  4/69 (5.80%) 
Dyspnea * 1  7/70 (10.00%)  7/69 (10.14%) 
Epistaxis * 1  1/70 (1.43%)  2/69 (2.90%) 
Hiccups * 1  3/70 (4.29%)  3/69 (4.35%) 
Hypoxia * 1  1/70 (1.43%)  1/69 (1.45%) 
Pharyngolaryngeal pain * 1  1/70 (1.43%)  0/69 (0.00%) 
Pleural effusion * 1  2/70 (2.86%)  0/69 (0.00%) 
Pneumonitis * 1  1/70 (1.43%)  0/69 (0.00%) 
Pneumothorax * 1  1/70 (1.43%)  0/69 (0.00%) 
Respiratory, thoracic and mediastinal disorders - Other * 1  1/70 (1.43%)  0/69 (0.00%) 
Tracheal mucositis * 1  0/70 (0.00%)  1/69 (1.45%) 
Skin and subcutaneous tissue disorders     
Alopecia * 1  8/70 (11.43%)  3/69 (4.35%) 
Dry skin * 1  4/70 (5.71%)  6/69 (8.70%) 
Erythema multiforme * 1  1/70 (1.43%)  1/69 (1.45%) 
Hyperhidrosis * 1  0/70 (0.00%)  1/69 (1.45%) 
Nail loss * 1  1/70 (1.43%)  1/69 (1.45%) 
Pain of skin * 1  0/70 (0.00%)  1/69 (1.45%) 
Palmar-plantar erythrodysesthesia syndrome * 1  3/70 (4.29%)  7/69 (10.14%) 
Photosensitivity * 1  0/70 (0.00%)  1/69 (1.45%) 
Pruritus * 1  2/70 (2.86%)  4/69 (5.80%) 
Rash maculo-papular * 1  6/70 (8.57%)  9/69 (13.04%) 
Skin and subcutaneous tissue disorders - Other * 1  3/70 (4.29%)  3/69 (4.35%) 
Skin hyperpigmentation * 1  0/70 (0.00%)  3/69 (4.35%) 
Skin induration * 1  0/70 (0.00%)  1/69 (1.45%) 
Skin ulceration * 1  2/70 (2.86%)  0/69 (0.00%) 
Telangiectasia * 1  0/70 (0.00%)  1/69 (1.45%) 
Urticaria * 1  0/70 (0.00%)  2/69 (2.90%) 
Vascular disorders     
Flushing * 1  1/70 (1.43%)  1/69 (1.45%) 
Hypertension * 1  1/70 (1.43%)  4/69 (5.80%) 
Hypotension * 1  5/70 (7.14%)  2/69 (2.90%) 
Phlebitis * 1  1/70 (1.43%)  0/69 (0.00%) 
Thromboembolic event * 1  1/70 (1.43%)  5/69 (7.25%) 
Vascular disorders - Other * 1  0/70 (0.00%)  1/69 (1.45%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (4.0)
The study was temporarily closed to accrual due to excessive GI AEs in the first 35 pts. The protocol was amended to adjust the chemotherapy and the study reopened (treatment descriptions reflect the revision).
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.org
Publications of Results:
Wong SJ, Moughan J, Meropol NJ, et al.: Efficacy endpoints of RTOG 0247: A randomized phase II study of neoadjuvant capecitabine (C) and irinotecan (I) or C and oxaliplatin (O) with concurrent radiation therapy (RT) for locally advanced rectal cancer. [Abstract] J Clin Oncol 29 (Suppl 15): A-3517, 2011.
Wong SJ, Winter K, Meropol NJ, et al.: RTOG 0247: A randomized phase II study of neoadjuvant capecitabine and irinotecan versus capecitabine and oxaliplatin with concurrent radiation therapy for locally advanced rectal cancer. [Abstract] J Clin Oncol 26 (Suppl 15): A-4021, 2008.
Layout table for additonal information
Responsible Party: Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier: NCT00081289     History of Changes
Other Study ID Numbers: RTOG-0247
CDR0000350136
First Submitted: April 7, 2004
First Posted: April 8, 2004
Results First Submitted: May 23, 2013
Results First Posted: November 25, 2013
Last Update Posted: February 17, 2017