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

Primary Purpose

Colon Cancer

Status

Completed

Phase

Not Applicable

Locations

Belgium

Study Type

Interventional

Intervention

FOLFOX

About this trial

This is an interventional treatment trial for Colon Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

adjuvant FOLFOX (1 pre-operative cycle)

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Examine the predictive value of PET-assessed tumour FDG uptake changes after one course of preoperative chemotherapy on OS

Evaluate the best cut-off value for relative delta SUV in assessment of preoperative chemotherapy response by FDG-PET/CT imaging.

Analyze the cost-effectiveness of preoperative chemo-sensitivity testing

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

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

Create a frozen tumour bank for future studies

Full Information

NCT ID

NCT00994864

First Posted

October 13, 2009

Last Updated

August 4, 2023

Sponsor

Jules Bordet Institute

1. Study Identification

Unique Protocol Identification Number

NCT00994864

Brief Title

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

Acronym

PePiTA

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Completed

Study Start Date

November 2009 (undefined)

Primary Completion Date

December 2022 (Actual)

Study Completion Date

December 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Jules Bordet Institute

4. Oversight

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Colon Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

235 (Actual)

8. Arms, Groups, and Interventions

Arm Title

adjuvant FOLFOX (1 pre-operative cycle)

Arm Type

Other

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

FOLFOX

Other Intervention Name(s)

FOLFOX-4 or equivalent

Intervention Description

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

Primary Outcome Measure Information:

Title

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.

Time Frame