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Chemotherapy Plus Radiation Therapy in Treating Patients With Stage II or Stage III Anal Cancer

NCT00003596 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 682

Last updated 2017-01-04

No results posted yet for this study

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 or combining radiation therapy with chemotherapy may kill more tumor cells. It is not yet known whether fluorouracil and mitomycin plus radiation therapy is more effective than fluorouracil and cisplatin plus radiation therapy for anal cancer.

PURPOSE: This randomized phase III trial is studying fluorouracil and mitomycin plus radiation therapy to see how well it works compared to fluorouracil and cisplatin plus radiation therapy in treating patients with stage II or stage III anal cancer.

Conditions

Interventions

DRUG

cisplatin

DRUG

fluorouracil

DRUG

mitomycin C

RADIATION

radiation therapy

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Eastern Cooperative Oncology Group

    collaborator NETWORK

  • Cancer and Leukemia Group B

    collaborator NETWORK

  • SWOG Cancer Research Network

    collaborator NETWORK

  • North Central Cancer Treatment Group

    collaborator NETWORK

  • Radiation Therapy Oncology Group

    lead NETWORK

Principal Investigators

  • Jaffer A. Ajani, MD · M.D. Anderson Cancer Center

  • Al B. Benson, MD, FACP · Robert H. Lurie Cancer Center

  • Joel E. Tepper, MD · UNC Lineberger Comprehensive Cancer Center

  • John S. MacDonald, MD · Beth Israel Comprehensive Cancer Center - West Side Campus

  • Michael G. Haddock, MD · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT

Eligibility

Min Age
18 Years
Max Age
120 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1998-10-31
Primary Completion
2005-10-31
Completion
2016-12-31

Countries

  • United States
  • South Africa

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00003596 on ClinicalTrials.gov