Clinical trial · Interventional
Preoperative Chemosensitivity Testing to Predict Treatment Benefit in Adjuvant Stage III Colon Cancer
Preoperative Chemosensitivity Testing as Predictor of Treatment Benefit in Adjuvant Stage III Colon Cancer: PePiTA Trial
NCT00994864CI-TRIAL-00068619PePiTAcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colon Cancer | Malignant Colon Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| FOLFOX | Drug | FOLFOX Regimen | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- adjuvant FOLFOX (1 pre-operative cycle)
- description
- One cycle of preoperative standard FOLFOX chemotherapy followed by eleven cycles post-operatively. PET/CT before and after the pre-operative chemotherapy cycle.
- interventionNames
- Drug: FOLFOX
Primary outcomes (1)
- 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.
- timeFrame
- Within 3 years after completion of adjuvant chemotherapy
Secondary outcomes (6)
- measure
- Examine the predictive value of PET-assessed tumour FDG uptake changes after one course of preoperative chemotherapy on OS
- timeFrame
- Within 3 years after completion of adjuvant chemotherapy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (2)
- DERIVEDRothe 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. PMID 30943928
- DERIVEDHendlisz 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