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Colon CancerPePiTANCT00994864

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

A study testing FOLFOX in people with Colon Cancer, run by Jules Bordet Institute at 21 sites in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colon Cancer
What is being tested?
FOLFOX
Could I receive a placebo?
No, everyone receives an active treatment
How many people
235 participants
Where
21 sitesBelgium
Study dates
Nov 2009to Dec 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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 -

Who cannot join

  • 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
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  • 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

Trial locations and contacts

21 sites in 1 country.

21 sites in 1 country

Belgium21 sites

  • Clinique St-Luc Bouge

    Bouge, 5004

  • Hôpital Erasme

    Brussels, 1000

  • Jules Bordet Institute

    Brussels, 1000

  • CHU Brugmann

    Brussels, 1020

  • IRIS Etterbeek-Ixelles

    Brussels, 1050

  • Clin Université St-Luc Bruxelles

    Brussels, 1200

  • HIS IZZ Bracops

    Brussels

  • Grand Hôpital Charleroi

    Charleroi

  • UZ Antwerp

    Edegem, 2650

  • UZ Gent

    Ghent, 9000

  • AZ Groeninge

    Kortrijk, 8500

  • CHR Citadelle de Liege

    Liège, 4000

  • CHU De Liège

    Liège, 4000

  • Clinique St-Joseph

    Liège, 4000

  • ZNA - Jan Palfijin

    Merksem, 2170

  • CHU Ambroise Paré

    Mons, 7000

  • CHR Namur

    Namur, 5000

  • AZ Damiaan

    Ostend, 8400

  • clinique St Pierre Ottignies

    Ottignies

  • AZ Turnhout

    Turnhout

  • Clinique Universites UCL Mont-Godinne

    Yvoir, 5530

Other trials in Belgium

About this study

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

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.

Read the 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.

Conditions
Colon Cancer
Being tested
FOLFOX
Medical subject headings
Colonic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FOLFOXDrug

    Also called FOLFOX-4 or equivalent

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

Study groups in NCT00994864
Study groupRoleWhat they receive
adjuvant FOLFOX (1 pre-operative cycle)OtherOne cycle of preoperative standard FOLFOX chemotherapy followed by eleven cycles post-operatively. PET/CT before and after the pre-operative chemotherapy cycle.
Receives: Drug: FOLFOX

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Within 3 years after completion of adjuvant chemotherapy

Secondary outcomes (6)

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

    Measured: Within 3 years after completion of adjuvant chemotherapy

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

    Measured: Within 3 years after completion of adjuvant chemotherapy

  3. Analyze the cost-effectiveness of preoperative chemo-sensitivity testing

    Measured: Within 3 years after completion of adjuvant chemotherapy

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

    Measured: Within 3 years after completion of adjuvant chemotherapy

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

    Measured: Within 3 years after completion of adjuvant chemotherapy

  6. Create a frozen tumour bank for future studies

    Measured: Within 2 years from the beginning of study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Oct 2009 (estimated)
  2. Study startNov 2009
  3. Primary completionDec 2022
  4. Study completionDec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
235 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00994864
Sponsor's protocol ID
PEPITA 001
Other IDs
EudraCT number: 2009-011445-13
Acronym
PePiTA
Status last verified
Feb 2023
First submitted
13 Oct 2009
Last updated
7 Aug 2023
Results posted
No
Data monitoring committee
No

Publications

  • Rothe F, Maetens M, Rouas G, Paesmans M, Van den Eynde M, Van Laethem JL, Vergauwe P, Deboever G, Bareche Y, Vandeputte C, Ignatiadis M, Hendlisz A. CTCs as a prognostic and predictive biomarker for stage II/III Colon Cancer: a companion study to the PePiTA trial. BMC Cancer. 2019 Apr 3;19(1):304. doi: 10.1186/s12885-019-5528-1.

    PubMed 30943928

  • 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.

    PubMed 23587148

Questions about this trial

What is this clinical trial studying?

A study testing FOLFOX in people with Colon Cancer, run by Jules Bordet Institute at 21 sites in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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: Within 3 years after completion of adjuvant chemotherapy). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00994864, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2023.

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