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Preoperative Combined Radiation and Chemotherapy - Rectal Cancer

NCT00232453 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2011-02-15

No results posted yet for this study

Summary

There is no established standard preoperative treatment in rectal cancer. Two large randomized studies in North America closed from lack of accrual; therefore the only method of assessing preoperative treatment in rectal cancer is from Phase II studies. This study builds on the experience at PMH gained in two previous studies which demonstrated a lower than expected toxicity with concurrent 5FU infusion and external radiotherapy. The current standard at PMH is preoperative radiation, 46Gy in 23 fractions with concurrent 5FU infusion 225mg/m2. An increase of radiation dose and consequent increase in chemotherapy may improve the response rate, but may also increase toxicity. It is proposed to increase the dose of radiotherapy to 50Gy in 25 fractions with concurrent chemotherapy and measure acute toxicity and complete remission rate.

Conditions

  • Rectal Neoplasms

Interventions

PROCEDURE

Combined Radiation and Chemotherapy

Sponsors & Collaborators

  • Princess Margaret Hospital, Canada

    collaborator OTHER

  • University Health Network, Toronto

    lead OTHER

Principal Investigators

  • James Brierley, MD · Princess Margaret Hospital, Canada

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-03-31
Primary Completion
2004-12-31
Completion
2004-12-31

Countries

  • Canada

Study Locations

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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 NCT00232453 on ClinicalTrials.gov