Surgery With or Without Chemotherapy and Radiation Therapy in TreatingPatients With Stage I Rectal Cancer

NCT00023751 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 320

Last updated 2016-07-06

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. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining surgery with chemotherapy and radiation therapy may kill more tumor cells and prevent recurrence of the cancer.

PURPOSE: Phase II trial to study the effectiveness of surgery with or without chemotherapy and radiation therapy in treating patients who have stage I rectal cancer.

Conditions

Interventions

DRUG

leucovorin calcium

PROCEDURE

conventional surgery

RADIATION

radiation therapy

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH
  • Alliance for Clinical Trials in Oncology

    lead OTHER

Principal Investigators

  • Ronald Bleday, MD · Dana-Farber/Brigham and Women's 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
2001-07-31
Primary Completion
2004-04-30
Completion
2004-04-30

Countries

  • United States
  • Canada
  • Puerto Rico

Study Locations

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Entities

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 NCT00023751 on ClinicalTrials.gov