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Preoperative Chemosensitivity Testing to Predict Treatment Benefit in Adjuvant Stage III Colon Cancer

NCT00994864 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 235

Last updated 2023-08-07

No results posted yet for this study

Summary

The primary working hypothesis is that preoperative chemo-sensitivity testing using fluorodeoxyglucose positron emission tomography (FDG-PET) performed before and after one course of FOLFOX (folinic acid, fluorouracil, oxaliplatin) can identify the patients that will least likely have a significant benefit from adjuvant FOLFOX for stage III colon cancer. The benefit will be analyzed by correlating the preoperative FDG-PET uptake changes to the disease free and overall survival.

Conditions

Interventions

DRUG

FOLFOX

One cycle of standard FOLFOX pre-operatively followed by 11 cycles of standard adjuvant FOLFOX chemotherapy.

Sponsors & Collaborators

  • Jules Bordet Institute

    lead OTHER

Principal Investigators

  • Alain Hendlisz, MD · Jules Bordet Institute, Brussels, Belgium

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-11-30
Primary Completion
2022-12-31
Completion
2022-12-31

Countries

  • Belgium

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 NCT00994864 on ClinicalTrials.gov