Stage III colon adenocarcinoma
Conditions
Interventions
Trade Name: Fluracedyl TEVA
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: FLUOROURACIL
CAS Number: 51-21-8
Other descriptive name: FLUOROURACIL
Trade Name: Eloxatin
Sponsors
Institut Jules Bordet-Université Libre de Bruxelles
Eligibility
Sex/Gender
All
Inclusion criteria
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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 225 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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 Objective: 1. Examine the predictive value of PET-assessed tumour FDG uptake changes after one course of preoperative chemotherapy on OS 2. Evaluate the best cut-off value for relative delta SUV in assessment of preoperative chemotherapy response by FDG-PET/CT imaging. 3. Analyze the cost-effectiveness of preoperative chemo-sensitivity testing Translational research: 4. Assess the predictive value of SNPs on toxicity- and drug target-related genes on DFS 5. To assess genomic rearrangements associated with response or resistance to FOLFOX treatment 6. To identify an immunologic signature associated with metabolic tumour response to FOLFOX therapy 7. Create a frozen tumour bank for future studies;Primary end point(s): 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.;Timepoint(s) of evaluation of this end point: 3-year DFS. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Examine the predictive value of PET-assessed tumour FDG uptake changes after one course of preoperative chemotherapy on OS 2. Evaluate the best cut-off value for relative delta SUV in assessment of preoperative chemotherapy response by FDG-PET/CT imaging. 3. Analyze the cost-effectiveness of preoperative chemo-sensitivity testing Translational research: 4. Assess the predictive value of SNPs on toxicity- and drug target-related genes on DFS 5. To assess genomic rearrangements associated with response or resistance to FOLFOX treatment 6. To identify an immunologic signature associated with metabolic tumour response to FOLFOX therapy 7. Create a frozen tumour bank for future studies;Timepoint(s) of evaluation of this end point: 1. Examine the predictive value of PET-assessed tumour FDG uptake changes after one course of preoperative chemotherapy on OS 2. Evaluate the best cut-off value for relative delta SUV in assessment of preoperative chemotherapy response by FDG-PET/CT imaging. 3. Analyze the cost-effectiveness of preoperative chemo-sensitivity testing Translational research: 4. Assess the predictive value of SNPs on toxicity- and drug target-related genes on DFS 5. To assess genomic rearrangements associated with response or resistance to FOLFOX treatment 6. To identify an immunologic signature associated with metabolic tumour response to FOLFOX therapy 7. Create a frozen tumour bank for future studies | — |
Countries
Belgium
Contacts
Public ContactAlain Hendlisz
Institut Jules Bordet
Outcome results
None listed