MetastasesPhase 3NCT00305188
Evaluation of the Efficacy of Xaliproden (SR57746A) in Preventing the Neurotoxicity of Oxaliplatin / 5FU/LV Chemotherapy.
A Phase 3 study testing Xaliproden (SR57746A), Oxaliplatin and 5-Fluorouracil in people with Metastases and Colorectal Neoplasms, run by Sanofi at 13 sites in 13 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastases, Colorectal Neoplasms, Colorectal Carcinoma
- What is being tested?
- Xaliproden (SR57746A), Oxaliplatin and 5-Fluorouracil
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 879 participants
- Where
- 13 sitesin 13 countries
- Study dates
- Dec 2005to Oct 2009
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
13 sites in 13 countries.
13 sites in 13 countries
United States1 site
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, 08807
United Kingdom1 site
Sanofi-Aventis Administrative Office
Guildford Surrey
About this study
Official 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
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).
- Conditions
- Metastases, Colorectal Neoplasms, Colorectal Carcinoma
- Being tested
- Xaliproden (SR57746A), Placebo, Oxaliplatin, 5-Fluorouracil, Leucovorin
- Keywords
- Neurotoxicity syndromes, Paresthesia, Oxaliplatin, Xaliproden
- Medical subject headings
- Neoplasm Metastasis, Colorectal Neoplasms, Neurotoxicity Syndromes, Paresthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xaliproden (SR57746A)Drug
oral administration
PlaceboDrug
oral administration
OxaliplatinDrug
IV administration
5-FluorouracilDrug
Also called 5-FU
IV administration
LeucovorinDrug
Also called LV
IV administration
| Study group | Role | What they receive |
|---|---|---|
| Xaliproden (SR57746A) | Experimental | Not described Receives: Drug: Xaliproden (SR57746A); Drug: Oxaliplatin; Drug: 5-Fluorouracil; Drug: Leucovorin |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo; Drug: Oxaliplatin; Drug: 5-Fluorouracil; Drug: Leucovorin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical evaluation of peripheral sensory neuropathy using the Oxaliplatin specific scale for dose adjustment
Measured: Q2W during treatment, Q4W to Q12W during post-treatment follow-up
Secondary outcomes (3)
Main: response rate using RECIST criteria
Measured: Q8W
Other: nerve conduction studies
Measured: baseline, end of treatment with oxaliplatin, end of treatment with study drug
Other: progression free survival and survival
Measured: Q8W and study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2006 (estimated)
- Study startDec 2005
- Primary completionOct 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for MetastasesStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 879 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00305188
- Sponsor's protocol ID
- EFC5505
- Other IDs
- EUDRACT : 2005-002570-30
- Status last verified
- Apr 2016
- First submitted
- 20 Mar 2006
- Last updated
- 4 May 2016
- Results posted
- No
Publications
Liu J, Wang X, Sahin IH, Imanirad I, Felder SI, Kim RD, Xie H. Tumor Response-speed Heterogeneity as a Novel Prognostic Factor in Patients With Metastatic Colorectal Cancer. Am J Clin Oncol. 2023 Feb 1;46(2):50-57. doi: 10.1097/COC.0000000000000972. Epub 2022 Dec 26.
PubMed 36606664Abdel-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.
PubMed 31378656Abdel-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.
PubMed 30679026
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT00305188
- Acronym / sponsor ID
- EFC5505
- Conditions
- Metastases, Colorectal Neoplasms, Colorectal Carcinoma
- Keywords
- Neurotoxicity syndromes, Paresthesia, Oxaliplatin, Xaliproden
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 879 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Dec 2005
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 21 Mar 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Xaliproden (SR57746A) | Experimental | Drug: Xaliproden (SR57746A), Drug: Oxaliplatin, Drug: 5-Fluorouracil, Drug: Leucovorin |
| Placebo | Placebo comparator | Drug: Placebo, Drug: Oxaliplatin, Drug: 5-Fluorouracil, Drug: Leucovorin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Xaliproden (SR57746A)oral administration | Drug | Xaliproden (SR57746A) |
| Placebooral administration | Drug | Placebo |
| OxaliplatinIV administration | Drug | Placebo, Xaliproden (SR57746A) |
| 5-FluorouracilAlso: 5-FUIV administration | Drug | Placebo, Xaliproden (SR57746A) |
| LeucovorinAlso: LVIV administration | Drug | Placebo, Xaliproden (SR57746A) |
Primary outcome
Clinical evaluation of peripheral sensory neuropathy using the Oxaliplatin specific scale for dose adjustment
Time frame: Q2W during treatment, Q4W to Q12W during post-treatment follow-up
3 secondary outcomes
Main: response rate using RECIST criteria
Time frame: Q8W
Other: nerve conduction studies
Time frame: baseline, end of treatment with oxaliplatin, end of treatment with study drug
Other: progression free survival and survival
Time frame: Q8W and study period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2016.
- Derived from this study: PubMed 36606664Liu J, Wang X, Sahin IH, Imanirad I, Felder SI, Kim RD, Xie H. Tumor Response-speed Heterogeneity as a Novel Prognostic Factor in Patients With Metastatic Colorectal Cancer. Am J Clin Oncol. 2023 Feb 1;46(2):50-57. doi: 10.1097/COC.0000000000000972. Epub 2022 Dec 26.
- Derived from this study: PubMed 31378656Abdel-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.
- Derived from this study: PubMed 30679026Abdel-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Sciences & Operations study director
Sanofi
13 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Xaliproden (SR57746A), Oxaliplatin and 5-Fluorouracil in people with Metastases and Colorectal Neoplasms, run by Sanofi at 13 sites in 13 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States, Argentina, Australia, Brazil, Canada and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical evaluation of peripheral sensory neuropathy using the Oxaliplatin specific scale for dose adjustment (time frame: Q2W during treatment, Q4W to Q12W during post-treatment follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00305188, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2016.