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Neo-adjuvant Chemoradiation With Oxaliplatin/5-FU in Rectal Cancer

NCT00831181 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2018-03-20

Study results available
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Summary

RATIONALE: 5FU based neoadjuvant chemoradiation (nCRT) is the standard of care for Stage II/III rectal cancer. Pathologic complete response (pCR) and downstaging have been associated with improved outcomes. The addition of oxaliplatin (OXA) to neoadjuvant therapy may reduce distant disease recurrence. Adjuvant treatment with OXA for rectal cancer has been motivated by benefits demonstrated in stage III colon cancer.

Objective: To determine the feasibility, toxicity, and efficacy of preoperative OXA/5FU and RT followed by total mesorectal excision (TME) and adjuvant

PURPOSE: This phase II trial is studying the side effects and how well giving neo-adjuvant combination chemotherapy with radiation works in treating patients undergoing surgery for rectal cancer.

Conditions

Interventions

DRUG

5-FU

5-FU: continuous infusion via portable pump during all RT (approximately 33 days)

DRUG

Oxaliplatin

Oxaliplatin: 50mg/m2 weekly dosing during RT (Day 1)

DRUG

leucovorin

Folinic Acid (Leucovorin): 400 mg/m2; 2-hour IV infusion simultaneously with oxaliplatin

PROCEDURE

mesorectal excision

mesorectal excision

Sponsors & Collaborators

  • Beth Israel Medical Center

    lead OTHER

Principal Investigators

  • Peter Kozuch, MD · Beth Israel Medical 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
2004-07-31
Primary Completion
2009-11-30
Completion
2009-11-30

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

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 NCT00831181 on ClinicalTrials.gov