Colorectal Carcinoma, Colorectal Neoplasms, Metastases
Conditions
Keywords
Neurotoxicity syndromes, Paresthesia, Oxaliplatin, Xaliproden
Brief summary
Primary Objective : Compare the risk of occurrence of Grade3-4 cumulative peripheral sensory neuropathy (PSN) relative to cumulative dose of oxaliplatin between treatment group and placebo group. Main Secondary Objective : Compare the response rate (RR) between treatment group and placebo group in order to ensure that the efficacy of the chemotherapy is not compromised by the addition of xaliproden to the chemotherapeutic regimen. Other Secondary Objectives : study of the neurotoxicity parameters (Duration of oxaliplatin-induced PSN (G2,3,4); overall incidence of PSN during treatment; dose of onset of PSN ; incidence of dose-reduction and dose delay due to PSN; incidence of oxaliplatin treatment discontinuation due to PSN; change in Nerve Conduction Studies (NCS)) ; study of the safety profile (other than PSN) ; study of the chemotherapy efficacy (progression free survival, overall survival).
Interventions
oral administration
DRUGPlacebo
oral administration
DRUGOxaliplatin
IV administration
DRUG5-Fluorouracil
IV administration
DRUGLeucovorin
IV administration
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Main inclusion criteria : * Histologically or cytologically-proven metastatic cancer of the colon or rectum. * Metastatic disease not amenable to potentially curative treatment (eg: inoperable metastatic disease). * Male or female aged \>18 years. * WHO Performance Status (PS) : 0 or 1. * Measurable disease. * No prior chemotherapeutic regimen for metastatic disease. * Disease-free interval from end of adjuvant therapy of at least 6 months (1 year if oxaliplatin was part of the adjuvant therapy). * Prior radiotherapy is permitted if it was not administered to target lesions identified for this study - unless progression within the radiation portal is documented - and provided it has been completed at least 3 weeks before randomization. * Signed written informed consent prior to study entry.
Exclusion criteria
Main
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical evaluation of peripheral sensory neuropathy using the Oxaliplatin specific scale for dose adjustment | Q2W during treatment, Q4W to Q12W during post-treatment follow-up |
Secondary
| Measure | Time frame |
|---|---|
| Main: response rate using RECIST criteria | Q8W |
| Other: nerve conduction studies | baseline, end of treatment with oxaliplatin, end of treatment with study drug |
| Other: progression free survival and survival | Q8W and study period |
Countries
Argentina, Australia, Brazil, Canada, Chile, Germany, Hungary, Italy, Poland, Portugal, Spain, United Kingdom, United States
Outcome results
None listed