Radiation Therapy Before Surgery Compared With Chemotherapy Plus Radiation After Surgery in Treating Patients With Rectal Cancer That Can Be Surgically Removed
|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: NCT00003422|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : December 4, 2013
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 or disease||Intervention/treatment||Phase|
|Colorectal Cancer||Drug: fluorouracil Drug: leucovorin calcium Procedure: adjuvant therapy Procedure: conventional surgery Procedure: neoadjuvant therapy Radiation: radiation therapy||Phase 3|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1800 participants|
|Official Title:||A Randomised Trial Comparing Pre-Operative Radiotherapy and Selective Post-Operative Chemoradiotherapy in Rectal Cancer|
|Study Start Date :||January 1998|
|Actual Study Completion Date :||June 2010|
- Local recurrence by biopsy, imaging, or imaging and carcinoembryonic antigen result
- Local recurrence-free survival
- Overall survival
- Time to appearance of distant metastases
- Disease-free survival
- Quality of life
- Economic implications
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003422
|Tom Baker Cancer Centre - Calgary|
|Calgary, Alberta, Canada, T2N 4N2|
|Winnipeg, Manitoba, Canada, R3E 0V9|
|Canada, New Brunswick|
|Saint John Regional Hospital|
|Saint John, New Brunswick, Canada, E2L 4L2|
|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|
|Hopital Charles Lemoyne|
|Greenfield Park, Quebec, Canada, J4V 2H1|
|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|