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

NCT00994864 | Completed

• 2 other identifiers: PEPITA 001EudraCT number: 2009-011445-13
• Study Type: interventional
• Target: 235
• Locations: 1 country
• Sites: 21

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.

Conditions

Colon Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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

• 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

• Analyze the cost-effectiveness of preoperative chemo-sensitivity testing

  Within 3 years after completion of adjuvant chemotherapy

• Assess the predictive value of circulating tumour cells on disease-free survival

  Within 3 years after completion of adjuvant chemotherapy

• Assess the predictive value of SNPs on toxicity- and drug target-related genes on DFS

  Within 3 years after completion of adjuvant chemotherapy

Study Arms (1)

adjuvant FOLFOX (1 pre-operative cycle)

OTHER

One cycle of preoperative standard FOLFOX chemotherapy followed by eleven cycles post-operatively. PET/CT before and after the pre-operative chemotherapy cycle.

Drug: FOLFOX

Interventions

FOLFOX DRUG

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

Also known as: FOLFOX-4 or equivalent

adjuvant FOLFOX (1 pre-operative cycle)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Jules Bordet Institute: lead

Study Sites (21)

Clinique St-Luc Bouge

Bouge, 5004, Belgium

Location

Hôpital Erasme

Brussels, 1000, Belgium

Location

Jules Bordet Institute

Brussels, 1000, Belgium

Location

CHU Brugmann

Brussels, 1020, Belgium

Location

IRIS Etterbeek-Ixelles

Brussels, 1050, Belgium

Location

Clin Université St-Luc Bruxelles

Brussels, 1200, Belgium

Location

HIS IZZ Bracops

Brussels, Belgium

Location

Grand Hôpital Charleroi

Charleroi, Belgium

Location

UZ Antwerp

Edegem, 2650, Belgium

Location

UZ Gent

Ghent, 9000, Belgium

Location

AZ Groeninge

Kortrijk, 8500, Belgium

Location

CHR Citadelle de Liege

Liège, 4000, Belgium

Location

CHU De Liège

Liège, 4000, Belgium

Location

Clinique St-Joseph

Liège, 4000, Belgium

Location

ZNA - Jan Palfijin

Merksem, 2170, Belgium

Location

CHU Ambroise Paré

Mons, 7000, Belgium

Location

CHR Namur

Namur, 5000, Belgium

Location

AZ Damiaan

Ostend, 8400, Belgium

Location

clinique St Pierre Ottignies

Ottignies, Belgium

Location

AZ Turnhout

Turnhout, Belgium

Location

Clinique Universites UCL Mont-Godinne

Yvoir, 5530, Belgium

Location

Related Publications (1)

• Hendlisz A, Golfinopoulos V, Deleporte A, Paesmans M, Mansy HE, Garcia C, Peeters M, Annemans L, Vandeputte C, Maetens M, Borbath I, Dresse D, Houbiers G, Fried M, Awada A, Piccart M, Laethem JL, Flamen P. Preoperative chemosensitivity testing as Predictor of Treatment benefit in Adjuvant stage III colon cancer (PePiTA): protocol of a prospective BGDO (Belgian Group for Digestive Oncology) multicentric study. BMC Cancer. 2013 Apr 12;13:190. doi: 10.1186/1471-2407-13-190.

  PMID: 23587148 DERIVED

MeSH Terms

Conditions

Colonic Neoplasms

Interventions

Folfox protocol

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Alain Hendlisz, MD

  Jules Bordet Institute, Brussels, Belgium

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2009
• First Posted: October 14, 2009
• Study Start: November 1, 2009
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: August 7, 2023

Record last verified: 2023-02

Locations

BE (21)