Preoperative Chemosensitivity Testing as Predictor of Treatment Benefit in Adjuvant Stage III Colon Cancer: PePiTA Trial
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.
Interventional
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Examine the predictive value of PET-assessed tumour FDG uptake response after one course of preoperative chemotherapy on the outcome of adjuvant therapy, measured by 3-year DFS.
Within 3 years after completion of adjuvant chemotherapy
No
Alain Hendlisz, MD
Principal Investigator
Jules Bordet Institute, Brussels, Belgium
Belgium: Federal Agency for Medicinal Products and Health Products
PEPITA 001
NCT00994864
November 2009
November 2014
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