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Radiation Therapy Before Surgery Compared With Chemotherapy Plus Radiation After Surgery in Treating Patients With Rectal Cancer That Can Be Surgically Removed Clinical Trials References presented on Clinical Trials Search isn't meant to be a substitute for proven healthcare advice, trips or professional assistance using a genuine physician. We are not docs. Always confer with your physician about Radiation Therapy Before Surgery Compared With Chemotherapy Plus Radiation After Surgery in Treating Patients With Rectal Cancer That Can Be Surgically Removed conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Radiation Therapy Before Surgery Compared With Chemotherapy Plus Radiation After Surgery in Treating Patients With Rectal Cancer That Can Be Surgically Removed Clinical research trials and Radiation Therapy Before Surgery Compared With Chemotherapy Plus Radiation After Surgery in Treating Patients With Rectal Cancer That Can Be Surgically Removed healthcare trials happen in hundreds of localities throughout the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the potency of new drugs. The propose of the studies / projects is to answer particular human health questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to detect cures for all sorts of conditions, such as Radiation Therapy Before Surgery Compared With Chemotherapy Plus Radiation After Surgery in Treating Patients With Rectal Cancer That Can Be Surgically Removed. Radiation Therapy Before Surgery Compared With Chemotherapy Plus Radiation After Surgery in Treating Patients With Rectal Cancer That Can Be Surgically Removed Clinical Trials and other clinical trials allow volunteers to acquire healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Radiation Therapy Before Surgery Compared With Chemotherapy Plus Radiation After Surgery in Treating Patients With Rectal Cancer That Can Be Surgically Removed clinical trial. Subjects frequently obtain the most expert healthcare possible for their Radiation Therapy Before Surgery Compared With Chemotherapy Plus Radiation After Surgery in Treating Patients With Rectal Cancer That Can Be Surgically Removed condition. Risks are a reality, nevertheless, and can include more or frequent doctor trips, medical risks (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with stern guidelines to protect clinical trials patients.
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Home > "R" Clinical Trials Conditions > Radiation Therapy Before Surgery Compared With Chemotherapy Plus Radiation After Surgery in Treating Patients With Rectal Cancer That Can Be Surgically Removed  Radiation Therapy Before Surgery Compared With Chemotherapy Plus Radiation After Surgery in Treating Patients With Rectal Cancer That Can Be Surgically Removed
Radiation Therapy Before Surgery Compared With Chemotherapy Plus Radiation After Surgery in Treating Patients With Rectal Cancer That Can Be Surgically Removed
For Condition: adenocarcinoma of the rectum,stage 3 rectal cancer,stage 2 rectal cancer,stage 1 rectal cancer
Status: Recruiting
Sponsor(s): Medical Research Council , National Cancer Institute of Canada
Synopsis: 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: Randomizedphase III trial to compare the effectiveness of radiation therapy before surgery with chemotherapy and radiation therapy after surgery in treating patients who have rectal cancer that can be surgically removed.
Details: OBJECTIVES: - Compare local recurrence free rates and quality of life in patients with operable rectal cancer receiving preoperative radiotherapy versus patients receiving selective postoperative chemoradiotherapy. - Determine local recurrence free survival, overall survival, time to appearance of distant metastases, disease free survival and morbidity in these patients. 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). - Arm I: Patients receive radiotherapy in 5 fractions over 1 week prior to surgery. Patients undergo surgery within 7 days of the last fraction of radiotherapy. - Arm II: Patients receive chemoradiotherapy 4-12 weeks after surgery (if circumferential resection margins are histologically involved by tumor). 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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /75 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed adenocarcinoma of the rectum (defined as lower edge of tumor within 15 cm of anal verge) - Tumor considered potentially operable - No evidence of metastases indicated by liver ultrasound or CT scan; chest x-ray; or renal, liver, and bone profiles PATIENT CHARACTERISTICS: Age: - 75 and under Performance status: - Not specified Life expectancy: - Not specified Hematopoietic: - Not specified Hepatic: - Not specified Renal: - Not specified Cardiovascular: - No uncontrolled heart failure or angina Other: - No other concurrent uncontrolled medical illness (e.g., infection) - No other prior or concurrent malignancy likely to interfere with the protocol treatments or comparisons PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - Not specified Endocrine therapy - Not specified Radiotherapy - Not specified Surgery - Not specified
Total Enrollment:
Location and Contact Information:
Overall Study Official:
R.Steele, Study Chair, Ninewells Hospital and Medical School
Hopital Charles Lemoyne *Recruiting*
Greenfield Park, Quebec, J4V 2H1
Canada
Recruiting Jean Couture 514-466-500 ext. 3028
Ninewells Hospital and Medical School *Recruiting*
Dundee, Scotland, DD1 9SY
United Kingdom
Recruiting R. Steele 44-1382-660-111
Additional Information:
Study ID Numbers: CDR0000066442; MRC-CR07,EU-98008,CAN-NCIC-C016,ISRCTN28785842
Study Start Date:
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003422
Other Stage 2 Rectal Cancer Studies:
1. Comparison of Two Types of Surgery in Treating Patients With Rectal Cancer
2. Neoadjuvant Chemoradiotherapy and Adjuvant Chemotherapy in Treating Patients Who Are Undergoing Surgical Resection for Locally Advanced Rectal Cancer
3. PET and CT Scans in Patients With Locally Advanced Primary Rectal Cancer That Can Be Removed During Surgery
4. Lymph Node Mapping and Sentinel Lymph Node Biopsy in Patients With Stage I, Stage II, or Stage III Colorectal Cancer
5. Biological Therapy With Combination Chemotherapy in Patients With Colorectal Cancer
Related Studies:
Other stage 2 rectal cancer Clinical Trials
Other Quebec Clinical Trials
Other Greenfield Park Clinical Trials
Radiation Therapy Before Surgery Compared With Chemotherapy Plus Radiation After Surgery in Treating Patients With Rectal Cancer That Can Be Surgically Removed
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