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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00994864
Other study ID # PEPITA 001
Secondary ID EudraCT number:
Status Completed
Phase N/A
First received
Last updated
Start date November 2009
Est. completion date December 2022

Study information

Verified date February 2023
Source Jules Bordet Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 235
Est. completion date December 2022
Est. primary completion date December 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Age 18 years or older - Clinical/radiological evaluation compatible with stage III colon adenocarcinoma - No prior chemotherapy - No prior abdominal or pelvic irradiation - WHO performance status 0 or 1 - Effective contraception during the study and the following six months - Signed informed consent obtained prior to any study-specific screening procedures - Tumour considered as curatively resectable (R0) based on standard preoperative evaluations - White blood cell count = 3×109/L with neutrophils = 1.5×109/L, platelet count = 100×109/L, haemoglobin = 9 g/dL (5.6 mmol/L) - Direct bilirubin = 1.5×ULN; ASAT and ALAT = 2.5×ULN; Alkaline phosphatase = 2.5×ULN; Serum creatinine = 1.5×ULN - Delay between assessment of screening criteria and first PET/CT < 21 days - Blood glucose < 150 mg/dl at the time of FDG administration. Insulin or oral anti-diabetic medication is not allowed on the days of PET/CT imaging. - Compliance to the first chemotherapy course to be administered before surgery - Delay between the first PET/CT imaging and the start of neoadjuvant FOLOFX < 7 days - Second PET/CT imaging performed on D14 (range: D13-D15, with D1 as the first day of chemo administration) - Delay between the second PET/CT and surgery < 7 days - Stage III (ypTNM) as assessed after surgery - CEA < 1.5 x ULN 1 month after surgery - Exclusion Criteria: - Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to screening. Incompletely healed wounds or anticipation of the need for major surgical procedure during the course of the study - Any suspicion of metastatic disease - Rectal cancer located within 15 cm from the anal verge by endoscopy or under the peritoneal reflection at surgery - Inflammatory bowel disease - Pregnancy (absence to be confirmed by ß-hCG blood test) or breast-feeding - History or current central nervous system disease or peripheral neuropathy - Hypersensitivity to any of the components of study treatments - Previous malignancy in the last five years except basal-cell carcinoma of the skin or in situ cervical carcinoma - Clinically relevant coronary artery disease or history of myocardial infarction in the last 6 weeks or high risk of uncontrolled arrhythmia - Medical, geographical, sociological, psychological or legal conditions that would not permit the patient to complete the study or sign informed consent - Any significant disease which, in the investigator's opinion, would exclude the patient from the study

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Belgium Clinique St-Luc Bouge Bouge
Belgium CHU Brugmann Brussels
Belgium Clin Université St-Luc Bruxelles Brussels
Belgium HIS IZZ Bracops Brussels
Belgium Hôpital Erasme Brussels
Belgium IRIS Etterbeek-Ixelles Brussels
Belgium Jules Bordet Institute 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

Sponsors (1)

Lead Sponsor Collaborator
Jules Bordet Institute

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Secondary Examine the predictive value of PET-assessed tumour FDG uptake changes after one course of preoperative chemotherapy on OS Within 3 years after completion of adjuvant chemotherapy
Secondary Evaluate the best cut-off value for relative delta SUV in assessment of preoperative chemotherapy response by FDG-PET/CT imaging. Within 3 years after completion of adjuvant chemotherapy
Secondary Analyze the cost-effectiveness of preoperative chemo-sensitivity testing Within 3 years after completion of adjuvant chemotherapy
Secondary Assess the predictive value of circulating tumour cells on disease-free survival Within 3 years after completion of adjuvant chemotherapy
Secondary Assess the predictive value of SNPs on toxicity- and drug target-related genes on DFS Within 3 years after completion of adjuvant chemotherapy
Secondary Create a frozen tumour bank for future studies Within 2 years from the beginning of study
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