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Neo-Adjuvant FOLFOX for Rectal Carcinoma

NCT00832299 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2018-03-01

Study results available
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Summary

A Phase II open- labeled, prospective study to determine the efficacy of pre-operative chemotherapy with six cycles of modified FOLFOX 6 followed by total mesorectal excision (TME) followed by an additional six cycles of FOLFOX 6.

The objectives of this study are the following:

1. The primary endpoint of this trial is pathologic complete response (response rate).
2. Secondary endpoints will include observation of overall pathologic response rate, correlation of pathologic staging with pre-operative ultrasound and pelvic MRI staging, as well as observation of toxic side effects, patterns of disease relapse, disease-free survival outcomes and overall survival outcomes.

Conditions

  • Rectal Neoplasms

Interventions

DRUG

FOLFOX

6 cycles of neo-adjuvant mFOLFOX6

PROCEDURE

total mesorectal excision (TME)

TME will be done 4-6 weeks after 6 cycles of neo-adjuvant FOLFOX.

Sponsors & Collaborators

  • St. Luke's-Roosevelt Hospital Center

    collaborator OTHER

  • 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
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2011-08-31
Completion
2011-08-31

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 NCT00832299 on ClinicalTrials.gov