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

NCT00002896 | Unknown Phase 3

• 3 other identifiers: CDR0000065222CNR-9604EU-96047
• Study Type: interventional
• Target: 774
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Colorectal Cancer

Keywords

stage II rectal cancer; stage III rectal cancer; recurrent rectal cancer; adenocarcinoma of the rectum; mucinous adenocarcinoma of the rectum

Interventions

chemotherapy DRUG

fluorouracil DRUG

leucovorin calcium DRUG

conventional surgery PROCEDURE

low-LET cobalt-60 gamma ray therapy RADIATION

low-LET photon therapy RADIATION

Eligibility Criteria

• Age: Up to 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• European Institute of Oncology: lead

Study Sites (1)

Ospedale St. Santa Chiara

Pisa, 56100, Italy

Location

Related Publications (1)

• 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.

  RESULT

MeSH Terms

Conditions

Colorectal Neoplasms; Rectal Neoplasms

Interventions

Drug Therapy; Fluorouracil; Leucovorin

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes

Study Officials

• Luca Cionini, MD

  Santa Chiara Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: May 13, 2004
• Study Start: September 1, 1993
• Last Updated: September 20, 2013

Record last verified: 2008-02

Locations

IT (1)