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Spots Global Cancer Trial Database for Preoperative Chemosensitivity Testing to Predict Treatment Benefit in Adjuvant Stage III Colon Cancer

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Trial Identification

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

Official Title: Preoperative Chemosensitivity Testing as Predictor of Treatment Benefit in Adjuvant Stage III Colon Cancer: PePiTA Trial

Study ID: NCT00994864

Conditions

Colon Cancer

Interventions

FOLFOX

Study Description

Brief 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.

Detailed Description: Patients with histological confirmed colon adenocarcinoma compatible with clinical stage II or III are eligible for study screening. Receipt of a signed informed consent and study inclusion should be done within 15 days after histological diagnosis. A usual workup for preoperative staging of colon cancer must be done not more than 1 month before study inclusion and include CEA assessment, positive histological sample for colon adenocarcinoma and chest and abdominal CT scan. After receipt of the written consent, the patient undergoes baseline PET/CT scan and donates blood samples for CTC and SNP analyses. Delay between baseline examinations and histological diagnosis must not exceed 21 days. The baseline examinations should be done within 1 week before beginning of the first course of FOLFOX chemotherapy. Thirteen to 15 days after chemotherapy, the PET/CT and blood sampling for CTC analysis are repeated. Standard surgery follows after 15 days but no more than 30 days from Day 1 of preoperative chemotherapy. Two frozen tissue cores are obtained during surgery and sent immediately in dry ice shipping to the central Tumour Bank (Jules Bordet Institute) or stored locally at -80°C to be sent in batches to the central tumour bank. Thereafter, the patient receives standard care, according to tumour pathological stage. In fully eligible patients, FOLFOX chemotherapy should be started not more than 45 days after surgery. In stage III patients otherwise ineligible, recommendation is to start FOLFOX chemotherapy within 45 days after surgery although such patients will not be included in the primary analysis. Treatment in case of stage II or stage IV colon cancer is left at investigator's discretion. Eleven courses of adjuvant FOLFOX are foreseen, in order to match the usual recommendation coming from the Mosaic Trial. Follow-up procedures after completion of adjuvant treatment will follow standard European clinical recommendations for stage II and III patients. Clinical follow-up data will be obtained for all patients, including those with stage II disease, with a minimum follow-up time of three years.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Clinique St-Luc Bouge, Bouge, , Belgium

Hôpital Erasme, Brussels, , Belgium

Jules Bordet Institute, Brussels, , Belgium

CHU Brugmann, Brussels, , Belgium

IRIS Etterbeek-Ixelles, Brussels, , Belgium

Clin Université St-Luc Bruxelles, Brussels, , Belgium

HIS IZZ Bracops, Brussels, , Belgium

Grand Hôpital Charleroi, Charleroi, , Belgium

UZ Antwerp, Edegem, , Belgium

UZ Gent, Gent, , Belgium

AZ Groeninge, Kortrijk, , Belgium

CHR Citadelle de Liege, Liege, , Belgium

CHU De Liège, Liège, , Belgium

Clinique St-Joseph, Liège, , Belgium

ZNA - Jan Palfijin, Merksem, , Belgium

CHU Ambroise Paré, Mons, , Belgium

CHR Namur, Namur, , Belgium

AZ Damiaan, Oostende, , Belgium

clinique St Pierre Ottignies, Ottignies, , Belgium

AZ Turnhout, Turnhout, , Belgium

Clinique Universites UCL Mont-Godinne, Yvoir, , Belgium

Contact Details

Name: Alain Hendlisz, MD

Affiliation: Jules Bordet Institute, Brussels, Belgium

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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