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Home > "N" Clinical Trials Conditions > Neoadjuvant Chemoradiotherapy and Adjuvant Chemotherapy in Treating Patients Who Are Undergoing Surgical Resection for Locally Advanced Rectal Cancer  Neoadjuvant Chemoradiotherapy and Adjuvant Chemotherapy in Treating Patients Who Are Undergoing Surgical Resection for Locally Advanced Rectal Cancer
Neoadjuvant Chemoradiotherapy and Adjuvant Chemotherapy in Treating Patients Who Are Undergoing Surgical Resection for Locally Advanced Rectal Cancer
For Condition: adenocarcinoma of the rectum,stage 2 rectal cancer,stage 3 rectal cancer
Status: Not yet recruiting
Sponsor(s): Radiation Therapy Oncology Group , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Chemoradiotherapy (combining chemotherapy with radiation therapy) before surgery may shrink the tumor so that it can be removed. Giving chemotherapy after surgery may kill any remaining tumor cells. PURPOSE: Randomizedphase II trial to compare the effectiveness of two different regimens of neoadjuvant chemoradiotherapy and adjuvant chemotherapy in treating patients who are undergoing surgical resection for locally advancedrectal cancer.
Details: OBJECTIVES: - Compare the pathologic complete response rate in patients with locally advanced rectal cancer undergoing surgical resection treated with 2 different regimens of neoadjuvant chemoradiotherapy and adjuvant chemotherapy. - Compare the time to treatment failure and patterns of failure in patients treated with these regimens. - Compare the incidence of hematologic and nonhematologic grade 3-4 toxicity, preoperatively, postoperatively, and overall, in patients treated with these regimens. - Compare the quality of life of patients treated with these regimens. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to clinical stage of tumor (T3 vs T4). Patients are randomized to 1 of 2 treatment arms. - Patients receive neoadjuvant therapy comprising radiotherapy once daily, 5 days a week, for 6 weeks and concurrent oral capecitabine twice daily (7 days a week) for 6 weeks and irinotecan IV over 1 hour on days 1, 8, 15, and 22. Patients undergo surgical resection 4-8 weeks after completing radiotherapy. Beginning 4-6 weeks after surgery, patients with completely resected disease and negative surgical margins receive adjuvant chemotherapy comprising irinotecan IV over 90 minutes and leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV continuously over 46 hours beginning on day 1. Treatment repeats every 14 days for a total of 9 courses. - Patients receive neoadjuvant therapy comprising radiotherapy and capecitabine as in arm I and oxaliplatin IV over 2 hours on days 1, 8, 15, 22, and 29. Patients undergo surgical resection 4-8 weeks after completing radiotherapy. Beginning 4-6 weeks after surgery, patients with completely resected disease and negative surgical margins receive adjuvant chemotherapy comprising oxaliplatin IV over 2 hours on day 1 and leucovorin calcium and fluorouracil as in arm I adjuvant chemotherapy. Treatment repeats every 14 days for a total of 9 courses. Quality of life is assessed at baseline, within 2 weeks before surgery, within 1 week after the completion of adjuvant chemotherapy, and then at 12 and 24 months. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 106 patients (53 per treatment arm) will be accrued for this study within 2 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Diagnosis of adenocarcinoma of the rectum - Clinical stage T3 or T4 disease by endorectal ultrasound or physical examination (for T4 lesions only) - Located up to 12 cm from the anal verge - No extension of disease into the anal canal - No evidence of distant metastases - No synchronous primary colon carcinomas except T1 lesions - Potentially resectable en bloc disease PATIENT CHARACTERISTICS: Age - 18 and over Performance status - Zubrod 0-2 Life expectancy - Not specified Hematopoietic - Absolute neutrophil count > 1,500/mm^3 - Platelet count > 100,000/mm^3 Hepatic - AST 1.5 times upper limit of normal (ULN) - Alkaline phosphatase 1.5 times ULN - Bilirubin 1.5 times ULN - No known uncontrolled coagulopathy Renal - Creatinine clearance > 50 mL/min Cardiovascular - No uncontrolled cardiac arrhythmias - No clinically significant cardiac disease - No congestive heart failure - No symptomatic coronary artery disease - No myocardial infarction within the past year Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for 30 days after study participation - No concurrent serious uncontrolled infection - No CNS disorder - No history of uncontrolled seizures - No malabsorption syndrome - No lack of physical integrity of the upper gastrointestinal tract - No psychiatric disability that would preclude study compliance or giving informed consent - No other malignancy within the past 5 years except nonmelanoma skin cancer, carcinoma in situ of the cervix, or ductal carcinoma in situ of the breast - No other serious uncontrolled medical condition that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy - No concurrent routine prophylactic filgrastim (G-CSF) Chemotherapy - No prior anticancer chemotherapy Endocrine therapy - Not specified Radiotherapy - No prior radiotherapy to the pelvis - No concurrent intensity-modulated radiotherapy Surgery - More than 4 weeks since prior major surgery Other - More than 4 weeks since prior participation in another clinical trial - No concurrent cimetidine - No concurrent sorivudine or brivudine
Total Enrollment:
Location and Contact Information:
Overall Study Official:
NealMeropol, Study Chair, Fox Chase Cancer Center
Additional Information:
Study ID Numbers: CDR0000350136; RTOG-0247
Study Start Date:
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00081289
Other Stage 2 Rectal Cancer Studies:
1. Combination Chemotherapy in Treating Patients With Colorectal Cancer
2. Radiation Therapy, Surgery, and Chemotherapy in Treating Patients With Rectal Cancer That Can Be Surgically Removed
3. Radiation Therapy Before Surgery Compared With Chemotherapy Plus Radiation After Surgery in Treating Patients With Rectal Cancer That Can Be Surgically Removed
4. Lymph Node Mapping and Sentinel Lymph Node Biopsy in Patients With Stage I, Stage II, or Stage III Colorectal Cancer
5. Combination Chemotherapy and Radiation Therapy in Treating Patients With Colorectal Cancer
Related Studies:
Other stage 2 rectal cancer Clinical Trials
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Neoadjuvant Chemoradiotherapy and Adjuvant Chemotherapy in Treating Patients Who Are Undergoing Surgical Resection for Locally Advanced Rectal Cancer
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