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| Sponsors and Collaborators: |
Medical Research Council National Cancer Institute of Canada |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00003422 |
Purpose
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether giving radiation therapy before surgery is more effective than giving chemotherapy plus radiation therapy after surgery in treating patients with rectal cancer.
PURPOSE: This randomized phase III trial is studying radiation therapy given before surgery to see how well it works compared to chemotherapy and radiation therapy given after surgery in treating patients with rectal cancer that can be surgically removed.
| Condition | Intervention | Phase |
|---|---|---|
|
Colorectal Cancer |
Drug: fluorouracil Drug: leucovorin calcium Procedure: adjuvant therapy Procedure: conventional surgery Procedure: neoadjuvant therapy Radiation: radiation therapy |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized |
| Official Title: | A Randomised Trial Comparing Pre-Operative Radiotherapy and Selective Post-Operative Chemoradiotherapy in Rectal Cancer |
| Estimated Enrollment: | 1800 |
| Study Start Date: | January 1998 |
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are stratified by a number of factors including surgeon.
Patients are randomized to receive preoperative radiotherapy (arm I) or postoperative chemoradiotherapy (arm II).
Radiotherapy is administered in 25 fractions over 5 weeks (5 days per week). During radiotherapy, patients either receive fluorouracil (5-FU) continuous infusion, 5-FU bolus IV and leucovorin calcium IV weekly, or a 5-day bolus schedule of 5-FU and leucovorin calcium.
Patients may then receive adjuvant chemotherapy as per local policy.
Quality of life assessments are made every 3 months for 1 year and then every 6 months for the next 2 years.
Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: Approximately 1800 patients will be accrued into this study.
Eligibility| Ages Eligible for Study: | up to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Contacts and Locations| Canada, Alberta | |
| Tom Baker Cancer Centre - Calgary | |
| Calgary, Alberta, Canada, T2N 4N2 | |
| Canada, Manitoba | |
| CancerCare Manitoba | |
| Winnipeg, Manitoba, Canada, R3E 0V9 | |
| Canada, New Brunswick | |
| Saint John Regional Hospital | |
| Saint John, New Brunswick, Canada, E2L 4L2 | |
| Canada, Ontario | |
| Cancer Centre of Southeastern Ontario at Kingston General Hospital | |
| Kingston, Ontario, Canada, K7L 5P9 | |
| Ottawa Hospital Regional Cancer Centre - General Campus | |
| Ottawa, Ontario, Canada, K1H 1C4 | |
| St. Catharines General Hospital at Niagara Health System | |
| St. Catharines, Ontario, Canada, L2R 5K3 | |
| Toronto Sunnybrook Regional Cancer Centre at Sunnybrook Health Sciences Centre | |
| Toronto, Ontario, Canada, M4N 3M5 | |
| Canada, Quebec | |
| Hopital Charles Lemoyne | |
| Greenfield Park, Quebec, Canada, J4V 2H1 | |
| United Kingdom, Scotland | |
| Ninewells Hospital and Medical School | |
| Dundee, Scotland, United Kingdom, DD1 9SY | |
| Study Chair: | R. Steele | Ninewells Hospital |
| Study Chair: | Jean Couture, MD | Hopital Charles Lemoyne |
More Information
| Study ID Numbers: | CDR0000066442, MRC-CR07, EU-98008, CAN-NCIC-C016, ISRCTN28785842 |
| Study First Received: | November 1, 1999 |
| Last Updated: | March 25, 2009 |
| ClinicalTrials.gov Identifier: | NCT00003422 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage I rectal cancer stage II rectal cancer stage III rectal cancer adenocarcinoma of the rectum |
|
Antimetabolites Immunologic Factors Gastrointestinal Diseases Rectal Neoplasms Colonic Diseases Leucovorin Rectal Diseases Vitamins Micronutrients Digestive System Neoplasms Vitamin B Complex Rectal Neoplasm Adjuvants, Immunologic |
Trace Elements Intestinal Diseases Folinic Acid Immunosuppressive Agents Intestinal Neoplasms Calcium, Dietary Rectal Cancer Digestive System Diseases Fluorouracil Gastrointestinal Neoplasms Adenocarcinoma Colorectal Neoplasms |
|
Antimetabolites Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Gastrointestinal Diseases Rectal Neoplasms Antineoplastic Agents Colonic Diseases Physiological Effects of Drugs Leucovorin Rectal Diseases Neoplasms by Site Therapeutic Uses Vitamins |
Micronutrients Digestive System Neoplasms Vitamin B Complex Growth Substances Intestinal Diseases Immunosuppressive Agents Intestinal Neoplasms Pharmacologic Actions Neoplasms Digestive System Diseases Fluorouracil Gastrointestinal Neoplasms Colorectal Neoplasms |