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Phase 1

• Conditions: Colorectal cancer stage II/III with adjuvant oxaliplatin-based chemotherapy (simplified FOLFOX4); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2017-002320-25-FR
• Lead Sponsor: ICANCER

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-06-07
• Last Update Posted: 10 September 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 210

Inclusion Criteria

1. Patients aged = 18 years old,
2. Eligible patient starting adjuvant oxaliplatin-based chemotherapy (simplified FOLFOX4) for stage II/III colorectal cancer,
3. Histological or cytological confirmation of a colorectal cancer,
4. PS (ECOG) = 2,
5. Normal hepatic function: total bilirubin =1.5 x upper limit of normal (ULN) (unless documented Gilbert’s syndrome); ASAT and ALAT =3 x ULN, and GGT=3 x ULN.
6. Normal renal function: creatinine clearance (CL) >40 mL/min or calculated creatinine clearance CL>40 mL/min (Cockcroft-Gault formula),
7. Normal cardiac function: ECG
8. Patients affiliated to the French national or European health insurance,
9. Patient must have signed a written informed consent form prior to any study specific procedures,
10. French language comprehension,
11. Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.
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 180
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

1. Metastatic cancer,
2. Diagnosis of neuropathy,
3. EORTC QLQ-CIPN20 sensory score > 6,
4. Previous neurotoxic chemotherapy treatment,
5. Patients with chronic obstructive pulmonary disease,
6. ALT / AST elevated more than 3 times the normal value,
7. Patients with known allergy or severe hypersensitivity to riluzole or any of the study drug excipients,
8. Dependence on alcohol and / or drugs,
9. Psychotic disorders
10. Women pregnant or breastfeeding,
11. Patients undergoing a measure of legal protection (trusteeship, guardianship ...).

Study & Design

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