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Sponsors and Collaborators: |
Radiation Therapy Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00081289 |
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: This randomized phase II trial is studying two different regimens of neoadjuvant chemoradiotherapy and adjuvant chemotherapy and comparing how well they work in treating patients who are undergoing surgical resection for locally advanced rectal cancer.
Condition | Intervention | Phase |
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Colorectal Cancer |
Drug: capecitabine Drug: irinotecan hydrochloride Drug: oxaliplatin Procedure: radiation therapy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
Official Title: | Randomized Phase II Trial Of Neoadjuvant Combined Modality Therapy For Locally Advanced Rectal Cancer |
Estimated Enrollment: | 141 |
Study Start Date: | March 2004 |
Estimated Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Arm I (neoadjuvant therapy): Experimental
Patients receive neoadjuvant therapy comprising radiotherapy once daily, 5 days a week, for 6 weeks and concurrent oral capecitabine twice daily (5 days a week) for 6 weeks and irinotecan IV over 1 hour on days 1, 8, 22, and 29.
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Drug: capecitabine
Given orally
Drug: irinotecan hydrochloride
Given IV
Procedure: radiation therapy
Given once daily 5 days a week for 6 weeks
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Arm II (neoadjuvant therapy): Experimental
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.
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Drug: capecitabine
Given orally
Drug: oxaliplatin
Given IV
Procedure: radiation therapy
Given once daily 5 days a week for 6 weeks
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OBJECTIVES:
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 undergo surgical resection 4-8 weeks after completing radiotherapy.
Beginning 4-6 weeks after surgery, patients receive adjuvant chemotherapy comprising oxaliplatin IV over 2 hours 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 undergo surgical resection 4-8 weeks after completing radiotherapy.
Beginning 4-6 weeks after surgery, patients receive adjuvant chemotherapy comprising oxaliplatin, 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 1 week after completion of radiotherapy, within 1 week after completion of adjuvant chemotherapy (12 months), and then at 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 141 patients (approximately 70 per treatment arm) will be accrued for this study within 2 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of adenocarcinoma of the rectum
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
United States, California | |
University of California Davis Cancer Center | |
Sacramento, California, United States, 95817 | |
United States, Florida | |
Baptist-South Miami Regional Cancer Program | |
Miami, Florida, United States, 33176 | |
United States, Illinois | |
Ingalls Cancer Care Center at Ingalls Memorial Hospital | |
Harvey, Illinois, United States, 60426 | |
United States, New Jersey | |
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton | |
Marlton, New Jersey, United States, 08053 | |
United States, Pennsylvania | |
Northeast Radiation Oncology Center | |
Dunmore, Pennsylvania, United States, 18512 |
Principal Investigator: | Neal J. Meropol, MD | Fox Chase Cancer Center |
Study ID Numbers: | CDR0000350136, RTOG-0247 |
Study First Received: | April 7, 2004 |
Last Updated: | November 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00081289 |
Health Authority: | United States: Federal Government |
stage III rectal cancer adenocarcinoma of the rectum stage II rectal cancer |
Capecitabine Digestive System Neoplasms Rectal Neoplasms Gastrointestinal Diseases Irinotecan Colonic Diseases Intestinal Diseases Rectal Diseases Camptothecin |
Intestinal Neoplasms Rectal neoplasm Oxaliplatin Digestive System Diseases Gastrointestinal Neoplasms Adenocarcinoma Rectal cancer Colorectal Neoplasms |
Antimetabolites Neoplasms Antimetabolites, Antineoplastic Neoplasms by Site Molecular Mechanisms of Pharmacological Action |
Antineoplastic Agents Therapeutic Uses Enzyme Inhibitors Antineoplastic Agents, Phytogenic Pharmacologic Actions |