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Proton Therapy With Capecitabine for Rectal Cancer

NCT00503932 · Status: WITHDRAWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL

Last updated 2012-03-22

No results posted yet for this study

Summary

The primary objective of the Phase I portion of this study is to evaluate the safety of a combination of capecitabine and proton therapy for patients with locally advanced or recurrent rectal cancer. The maximum tolerated dose (MTD) will be determined in the Phase I portion of this trial.

The primary objective of the Phase II portion of this study is to evaluate the local control rate in patients treated with the above regimen at the MTD.

Secondary Objectives:

1. To evaluate local tumor response in patients treated with the above regimen.
2. To evaluate the relapse-free and overall survival in patients treated with the above regimen.
3. To evaluate proton dosimetry in patients receiving this treatment.
4. To evaluate quality of life in patients receiving this therapy.

Conditions

Interventions

PROCEDURE

Proton Therapy

Radiation therapy 1 time a day, for 5 days in a row (Monday-Friday) for 6 -7 weeks (30-35 treatments in all).

DRUG

Capecitabine

825 mg/m\^2 by mouth (PO) twice daily on days receive radiation.

Sponsors & Collaborators

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Prajnan Das, MD · M.D. Anderson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-07-31
Primary Completion
2008-04-30
Completion
2008-04-30

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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 NCT00503932 on ClinicalTrials.gov