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Capecitabine, Oxaliplatin, and Radiation Therapy in Treating Patients With Stage II or Stage III Anal Cancer

NCT00093379 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2023-04-18

Study results available
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Summary

RATIONALE: Drugs used in chemotherapy, such as capecitabine and oxaliplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Capecitabine may stop the growth of tumor cells by stopping blood flow to the tumor. Radiation therapy uses high-energy x-rays to damage tumor cells. Capecitabine and oxaliplatin may make tumor cells more sensitive to radiation therapy. Combining capecitabine and oxaliplatin with radiation therapy may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving capecitabine and oxaliplatin together with radiation therapy works in treating patients with stage II or stage III anal cancer.

Conditions

Interventions

DRUG

Capecitabine

825 mg/m\^2 orally twice a day (BID), Mon-Fri during weeks 1, 2, 4, and 5.

DRUG

Oxaliplatin

50 mg/m\^2 by vein (IV) over 2 hours on days 1, 8, 22, and 29.

RADIATION

Radiation Therapy (XRT)

Undergo radiotherapy\* once daily on days 1-3, 6-10, 13-17, 20-24, 27-31, 34-38, and 41-42. \*Patients with T3-4 lesions undergo radiotherapy once daily on days 43 and 44.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Cathy Eng, MD · M.D. Anderson Cancer Center

  • Christopher H. Crane, MD · M.D. Anderson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-04-30
Primary Completion
2012-07-31
Completion
2012-07-31

Countries

  • United States

Study Locations

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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 NCT00093379 on ClinicalTrials.gov