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Comparison of Adjuvant Chemotherapy Regimens in Treating Stage II/III Rectal Cancer

NCT00068692 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 225

Last updated 2018-12-04

Study results available
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Summary

This randomized phase III trial is comparing the effectiveness of three adjuvant combination chemotherapy regimens in treating patients who are receiving radiation therapy and fluorouracil either before or after surgery for stage II or stage III rectal cancer. Drugs used in chemotherapy, such as irinotecan, fluorouracil, leucovorin, and oxaliplatin, 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. It is not yet known which adjuvant combination chemotherapy regimen is more effective in treating patients who are receiving radiation therapy and fluorouracil either before or after surgery for rectal cancer.

Conditions

  • Rectal Mucinous Adenocarcinoma
  • Rectal Signet Ring Cell Adenocarcinoma
  • Recurrent Rectal Carcinoma
  • Stage IIA Rectal Cancer AJCC v7
  • Stage IIB Rectal Cancer AJCC v7
  • Stage IIC Rectal Cancer AJCC v7
  • Stage IIIA Rectal Cancer AJCC v7
  • Stage IIIB Rectal Cancer AJCC v7
  • Stage IIIC Rectal Cancer AJCC v7
  • Stage IVA Rectal Cancer AJCC v7
  • Stage IVB Rectal Cancer AJCC v7

Interventions

RADIATION

Radiotherapy

Undergo external beam radiation therapy

DRUG

Fluorouracil

Given IV

DRUG

Leucovorin Calcium

Given IV

DRUG

Oxaliplatin

Given IV

DRUG

Irinotecan

Given IV

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Al Benson · Eastern Cooperative Oncology Group

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-10-15
Primary Completion
2016-11-15
Completion
2016-11-15
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs

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 NCT00068692 on ClinicalTrials.gov