Preoperative chemosensitivity testing as Predictor of Treatment benefit in Adjuvant stage III colon cancer

Phase 1

• Conditions: Stage III colon adenocarcinoma; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2009-011445-13-BE
• Lead Sponsor: Institut Jules Bordet-Université Libre de Bruxelles

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-09-10
• Last Update Posted: 19 December 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 225

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

*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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified