Radiation Therapy Before Surgery Compared With Chemotherapy Plus Radiation After Surgery in Treating Patients With Rectal Cancer That Can Be Surgically Removed - Full Text View

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 Procedure: radiation therapy	Phase III

MedlinePlus related topics:

Cancer Colorectal Cancer

ChemIDplus related topics:

Leucovorin Calcium Citrovorum factor Folinic acid calcium salt pentahydrate Leucovorin Fluorouracil Calcium gluconate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized

Official Title:	A Randomised Trial Comparing Pre-Operative Radiotherapy and Selective Post-Operative Chemoradiotherapy in Rectal Cancer

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Local recurrence by biopsy, imaging, or imaging and carcinoembryonic antigen result [ Designated as safety issue: No ]

Secondary Outcome Measures:

Local recurrence-free survival [ Designated as safety issue: No ]
Overall survival [ Designated as safety issue: No ]
Time to appearance of distant metastases [ Designated as safety issue: No ]
Disease-free survival [ Designated as safety issue: No ]
Morbidity [ Designated as safety issue: No ]
Quality of life [ Designated as safety issue: No ]
Economic implications [ Designated as safety issue: No ]

Estimated Enrollment:	1800
Study Start Date:	January 1998

Detailed Description:

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

Ages Eligible for Study:	up to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003422

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

Sponsors and Collaborators

Medical Research Council

National Cancer Institute of Canada

Investigators


Study Chair:	R. Steele	Ninewells Hospital

Study Chair:	Jean Couture, MD	Hopital Charles Lemoyne

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications of Results:

Quirke P, Sebag-Montefiore D, Steele R, et al.: Local recurrence after rectal cancer resection is strongly related to the plane of surgical dissection and is further reduced by pre-operative short course radiotherapy. Preliminary results of the Medical Research Council (MRC) CR07 trial. [Abstract] J Clin Oncol 24 (Suppl 18): A-3512, 2006.

Sebag-Montefiore D, Steele R, Quirke P, et al.: Routine short course pre-op radiotherapy or selective post-op chemoradiotherapy for resectable rectal cancer? Preliminary results of the MRC CR07 randomised trial. [Abstract] J Clin Oncol 24 (Suppl 18): A-3511, 2006.

Sebag-Montefiore D: An update report on the MRC CR07 trial. [Abstract] Br J Cancer 85 (suppl 1): A-9.3, 28, 2001.

Study ID Numbers:	CDR0000066442, MRC-CR07, EU-98008, CAN-NCIC-C016, ISRCTN28785842
First Received:	November 1, 1999
Last Updated:	May 23, 2008
ClinicalTrials.gov Identifier:	NCT00003422
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

stage I rectal cancer

stage II rectal cancer

stage III rectal cancer

adenocarcinoma of the rectum

Study placed in the following topic categories:

Digestive System Neoplasms

Rectal Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Leucovorin

Intestinal Diseases

Rectal Diseases

Intestinal Neoplasms

Rectal neoplasm

Digestive System Diseases

Fluorouracil

Gastrointestinal Neoplasms

Adenocarcinoma

Rectal cancer

Colorectal Neoplasms

Additional relevant MeSH terms:

Antimetabolites

Antimetabolites, Antineoplastic

Vitamin B Complex

Molecular Mechanisms of Pharmacological Action

Immunologic Factors

Antineoplastic Agents

Growth Substances

Physiological Effects of Drugs

Immunosuppressive Agents

Pharmacologic Actions

Neoplasms

Neoplasms by Site

Therapeutic Uses

Vitamins

Micronutrients

ClinicalTrials.gov processed this record on October 10, 2008

Sponsors and Collaborators:	Medical Research Council National Cancer Institute of Canada
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00003422