MedTrace Logo

Chemotherapy, Radiation Therapy, and Surgery in Treating Patients With Locally Advanced Rectal Cancer

NCT00003799 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2013-01-10

No results posted yet for this study

Summary

Phase I trial to study the effectiveness of radiation therapy plus chemotherapy followed by surgery and additional chemotherapy in treating patients who have advanced nonmetastatic primary cancer of the rectum. 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 chemotherapy, radiation therapy, and surgery may be an effective treatment for rectal cancer

Conditions

  • Adenocarcinoma of the Rectum
  • Mucinous Adenocarcinoma of the Rectum
  • Signet Ring Adenocarcinoma of the Rectum
  • Stage IIA Rectal Cancer
  • Stage IIB Rectal Cancer
  • Stage IIC Rectal Cancer
  • Stage IIIA Rectal Cancer
  • Stage IIIB Rectal Cancer
  • Stage IIIC Rectal Cancer

Interventions

DRUG

fluorouracil

Given IV

DRUG

oxaliplatin

Given IV

RADIATION

radiation therapy

Undergo radiotherapy

DRUG

leucovorin calcium

Given IV

PROCEDURE

therapeutic conventional surgery

Undergo surgery

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Daniel Haller · Eastern Cooperative Oncology Group

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1999-05-31
Primary Completion
2003-09-30

Countries

  • United States

Study Locations

More Related Trials

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 NCT00003799 on ClinicalTrials.gov