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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00305188




Registration number
NCT00305188
Ethics application status
Date submitted
20/03/2006
Date registered
21/03/2006
Date last updated
4/05/2016

Titles & IDs
Public title
Evaluation of the Efficacy of Xaliproden (SR57746A) in Preventing the Neurotoxicity of Oxaliplatin / 5FU/LV Chemotherapy.
Scientific title
A Multicenter, Randomized Double-blind Placebo Controlled Phase III Study of the Efficacy of Xaliproden in Preventing the Neurotoxicity of Oxaliplatin in First-line Treatment of Patients With Metastatic Colorectal Cancer Treated With Oxaliplatin / 5-FU/LV
Secondary ID [1] 0 0
EUDRACT : 2005-002570-30
Secondary ID [2] 0 0
EFC5505
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metastases 0 0
Colorectal Neoplasms 0 0
Colorectal Carcinoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Bowel - Back passage (rectum) or large bowel (colon)
Neurological 0 0 0 0
Other neurological disorders
Injuries and Accidents 0 0 0 0
Poisoning

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Xaliproden (SR57746A)
Treatment: Drugs - Placebo
Treatment: Drugs - Oxaliplatin
Treatment: Drugs - 5-Fluorouracil
Treatment: Drugs - Leucovorin

Experimental: Xaliproden (SR57746A) -

Placebo comparator: Placebo -


Treatment: Drugs: Xaliproden (SR57746A)
oral administration

Treatment: Drugs: Placebo
oral administration

Treatment: Drugs: Oxaliplatin
IV administration

Treatment: Drugs: 5-Fluorouracil
IV administration

Treatment: Drugs: Leucovorin
IV administration
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Clinical evaluation of peripheral sensory neuropathy using the Oxaliplatin specific scale for dose adjustment
Timepoint [1] 0 0
Q2W during treatment, Q4W to Q12W during post-treatment follow-up
Secondary outcome [1] 0 0
Main: response rate using RECIST criteria
Timepoint [1] 0 0
Q8W
Secondary outcome [2] 0 0
Other: nerve conduction studies
Timepoint [2] 0 0
baseline, end of treatment with oxaliplatin, end of treatment with study drug
Secondary outcome [3] 0 0
Other: progression free survival and survival
Timepoint [3] 0 0
Q8W and study period

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Main exclusion criteria :

* Any condition or past medical history that contra-indicates treatment with oxaliplatin and 5-FU, as reported in approved labeling information.
* Received chemotherapeutic agents other than 5-FU, LV, Levamisole, irinotecan, capecitabine, oxaliplatin as part of adjuvant therapy.
* Peripheral neuropathy >Grade 1.
* Concomitant treatments with drugs/ingredients reported to have a potential activity in preventing peripheral sensory neuropathy.
* Concurrent active cancer originating from a primary site other than colon or rectum.
* Presence of any symptom suggesting brain metastasis.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2009
Sample size
Target
Accrual to date
Final
879
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Sanofi-Aventis Administrative Office - Macquarie Park
Recruitment postcode(s) [1] 0 0
- Macquarie Park
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
New Jersey
Country [2] 0 0
Argentina
State/province [2] 0 0
Buenos Aires
Country [3] 0 0
Brazil
State/province [3] 0 0
Sao Paulo
Country [4] 0 0
Canada
State/province [4] 0 0
Laval
Country [5] 0 0
Chile
State/province [5] 0 0
Santiago
Country [6] 0 0
Germany
State/province [6] 0 0
Berlin
Country [7] 0 0
Hungary
State/province [7] 0 0
Budapest
Country [8] 0 0
Italy
State/province [8] 0 0
Milano
Country [9] 0 0
Poland
State/province [9] 0 0
Warszawa
Country [10] 0 0
Portugal
State/province [10] 0 0
Porto Salvo
Country [11] 0 0
Spain
State/province [11] 0 0
Barcelona
Country [12] 0 0
United Kingdom
State/province [12] 0 0
Guildford Surrey

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Sanofi
Address
Country

Ethics approval
Ethics application status

Summary
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).
Trial website
https://clinicaltrials.gov/study/NCT00305188
Trial related presentations / publications
Abdel-Rahman O. Effect of Body Mass Index on 5-FU-Based Chemotherapy Toxicity and Efficacy Among Patients With Metastatic Colorectal Cancer; A Pooled Analysis of 5 Randomized Trials. Clin Colorectal Cancer. 2019 Dec;18(4):e385-e393. doi: 10.1016/j.clcc.2019.07.005. Epub 2019 Jul 15.
Abdel-Rahman O. Impact of Sex on Chemotherapy Toxicity and Efficacy Among Patients With Metastatic Colorectal Cancer: Pooled Analysis of 5 Randomized Trials. Clin Colorectal Cancer. 2019 Jun;18(2):110-115.e2. doi: 10.1016/j.clcc.2018.12.006. Epub 2018 Dec 28.
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Sciences & Operations
Address 0 0
Sanofi
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00305188