Radiation Therapy Plus Chemotherapy Before Surgery With or Without Chemotherapy After Surgery in Treating Patients With Rectal Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2008 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00002896
First received: November 1, 1999
Last updated: September 19, 2013
Last verified: February 2008

November 1, 1999
September 19, 2013
September 1993
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Complete list of historical versions of study NCT00002896 on ClinicalTrials.gov Archive Site
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Radiation Therapy Plus Chemotherapy Before Surgery With or Without Chemotherapy After Surgery in Treating Patients With Rectal Cancer
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.

Interventional
Phase 3
Allocation: Randomized
Primary Purpose: Treatment
Colorectal Cancer
  • Drug: chemotherapy
  • Drug: fluorouracil
  • Drug: leucovorin calcium
  • Procedure: conventional surgery
  • Radiation: low-LET cobalt-60 gamma ray therapy
  • Radiation: low-LET photon therapy
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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.
 
Active, not recruiting
774
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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

Both
up to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT00002896
CDR0000065222, CNR-9604, EU-96047
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European Institute of Oncology
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Study Chair: Luca Cionini, MD Ospedale Santa Chiara Pisa
National Cancer Institute (NCI)
February 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP