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Radiation Therapy With or Without Chemotherapy After Surgery in Treating Patients With Stage IB or Stage IIA Cervical Cancer

2014-08-27 03:58:47 | BioPortfolio

Summary

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. Combining chemotherapy with radiation therapy may kill more tumor cells. It is not yet known whether giving radiation therapy with chemotherapy after surgery is more effective than radiation therapy alone after surgery in treating cervical cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with or without chemotherapy after surgery in treating patients with stage IB or stage IIA cervical cancer.

Description

OBJECTIVES: I. Compare relapse free and overall survival after radiation therapy with or without the sequential use of chemotherapy in patients with node positive stage IB or IIA cervical cancer. II. Compare the toxic effects of these two treatments in this patient population. III. Study the effect of the addition of chemotherapy on the pattern of relapse in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to institution, stage, site of lymph node involvement, parametrial invasion, resection margin status, diameter of the primary lesion, and preoperative brachtherapy. Patients are assigned to one of two treatment arms and begin therapy within 6 weeks of surgery. Arm I: Patients receive radiation therapy to the pelvis with or without brachytherapy and/or para-aortic irradiation for 4-5 weeks. Arm II: Patients receive radiation therapy as in arm I plus 1 of 5 different cisplatin-based combination chemotherapy regimens. The patients preferably receive chemotherapy before radiation therapy, unless doubtful or positive margins are present, then radiation therapy is given first. Regimen I: Cisplatin and fluorouracil are administered on days 1 and 2 of a 21 day cycle. Patients receive 4 cycles of therapy. Regimen II: Bleomycin is administered on day 1 and cisplatin and ifosfamide are administered on day 2 of a 21 day cycle. Patients receive 4 cycles of therapy. The regimen may also be given without bleomycin. Regimen III: Patients receive vindesine on days 1 and 8, cisplatin on day 1, bleomycin on days 2-4, and mitomycin on day 5 (cycles 1 and 3 only). Each cycle lasts 21 days and patients receive 4 cycles of therapy. Regimen IV: Cisplatin and vinblastine are administered on day 1 and bleomycin is administered on days 1, 8, and 15 of a 21 day cycle. Each patient receives 4 cycles of therapy. Regimen V: Patients receive cisplatin and methotrexate on day 1 of each 14 day cycle. Patients receive 6 cycles of therapy. Patients are followed every 3 months for the first 2 years, every 6 months for the next 3 years, then annually for the next 5 years.

PROJECTED ACCRUAL: Approximately 700 patients will be accrued for this study within 4 years.

Study Design

Primary Purpose: Treatment

Conditions

Cervical Cancer

Intervention

bleomycin sulfate, cisplatin, fluorouracil, ifosfamide, methotrexate, mitomycin C, vinblastine, vindesine, radiation therapy

Location

Derbyshire Royal Infirmary
Derby
England
United Kingdom
DE1 2QY

Status

Active, not recruiting

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:58:47-0400

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Medical and Biotech [MESH] Definitions

A complex of related glycopeptide antibiotics from Streptomyces verticillus consisting of bleomycin A2 and B2. It inhibits DNA metabolism and is used as an antineoplastic, especially for solid tumors.

An inorganic and water-soluble platinum complex. After undergoing hydrolysis, it reacts with DNA to produce both intra and interstrand crosslinks. These crosslinks appear to impair replication and transcription of DNA. The cytotoxicity of cisplatin correlates with cellular arrest in the G2 phase of the cell cycle.

Derivatives of chondroitin which have a sulfate moiety esterified to the galactosamine moiety of chondroitin. Chondroitin sulfate A, or chondroitin 4-sulfate, and chondroitin sulfate C, or chondroitin 6-sulfate, have the sulfate esterified in the 4- and 6-positions, respectively. Chondroitin sulfate B (beta heparin; DERMATAN SULFATE) is a misnomer and this compound is not a true chondroitin sulfate.

Toxic antibiotic of the mitomycin group, obtained from MITOMYCIN and also from Streptomyces ardus and other species. It is proposed as an antineoplastic agent, with some antibiotic properties.

An enzyme that catalyzes the activation of sulfate ions by ATP to form adenosine-5'-phosphosulfate and pyrophosphate. This reaction constitutes the first enzymatic step in sulfate utilization following the uptake of sulfate. EC 2.7.7.4.

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