Radiation Therapy Plus Chemotherapy Before Surgery With or Without Chemotherapy After Surgery in Treating Patients With Rectal Cancer
Recruitment status was Active, not recruiting
|First Received Date ICMJE||November 1, 1999|
|Last Updated Date||February 6, 2009|
|Start Date ICMJE||September 1993|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00002896 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Radiation Therapy Plus Chemotherapy Before Surgery With or Without Chemotherapy After Surgery in Treating Patients With Rectal Cancer|
|Official Title ICMJE||RANDOMIZED TRIAL OF CONCOMITANT PREOPERATIVE RADIO-CHEMOTHERAPY WITH OR WITHOUT POSTOPERATIVE CHEMOTHERAPY IN LOCALLY ADVANCED RECTAL CARCINOMA|
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug, giving the drugs in different ways, and combining chemotherapy with radiation therapy may kill more tumor cells.
PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy plus fluorouracil and leucovorin before surgery given with or without fluorouracil and leucovorin after surgery in patients with locally advanced rectal cancer.
OBJECTIVES: I. Assess the local recurrence rate, cost-benefit ratio, and acute and late toxicity associated with concomitant preoperative radiotherapy and fluorouracil/leucovorin (5-FU/CF) in patients with locally advanced adenocarcinoma of the rectum. II. Compare the relapse rate, survival rate, disease-free interval, and cost-benefit ratio associated with 6 courses of postoperative 5-FU/CF vs. no further treatment in these patients.
OUTLINE: This is a randomized study. Patients are stratified by tumor stage, age, type of surgery, and participating institution. Patients are randomly assigned to one of two groups. The first group receives radiotherapy to the tumor over 5 weeks and concomitant fluorouracil/leucovorin for 5 consecutive days on the first and fifth weeks. Four to six weeks later, patients undergo complete resection, followed upon recovery by fluorouracil/leucovorin every 4 weeks for 6 courses. The second group receives preoperative chemoradiotherapy followed by surgery, as above, with no postoperative treatment. Patients are followed for survival.
PROJECTED ACCRUAL: A total of 774 patients will be entered on this multicenter study.
|Study Type ICMJE||Interventional|
|Study Phase||Phase 3|
|Study Design ICMJE||Allocation: Randomized
Primary Purpose: Treatment
|Condition ICMJE||Colorectal Cancer|
|Study Arm (s)||Not Provided|
|Publications *||Cionini L, Cartei F, Manfredi B, et al.: Randomized study of preoperative chemoradiation (CTRT) in locally advanced rectal cancer: preliminary results. [Abstract] Int J Radiat Oncol Biol Phys 45 (3 Suppl): A-61, 178, 1999.|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Active, not recruiting|
|Estimated Enrollment ICMJE||774|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
DISEASE CHARACTERISTICS: Histologically confirmed adenocarcinoma or mucinous adenocarcinoma of the rectum Distal limit of tumor no higher than 12 cm from the anal verge on proctoscopy Locally advanced (T3-4 M0) tumor by one of the following: Partial fixation Complete stenosis Invasion beyond the muscular stratum on transrectal ultrasound
PATIENT CHARACTERISTICS: Age: 75 and under Performance status: WHO 0 or 1 Hematopoietic: WBC greater than 3,000 Platelets greater than 130,000 Hepatic: Not specified Renal: Creatinine less than 1.4 mg/dL Cardiovascular: No unstable angina No cardiac decompensation Other: No prior or concurrent malignancy
PRIOR CONCURRENT THERAPY: Not specified
|Ages||up to 75 Years|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||Italy|
|NCT Number ICMJE||NCT00002896|
|Other Study ID Numbers ICMJE||CDR0000065222, CNR-9604, EU-96047|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||European Institute of Oncology|
|Collaborators ICMJE||Not Provided|
|Information Provided By||National Cancer Institute (NCI)|
|Verification Date||February 2008|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP