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XENOX - Evaluation of the Efficacy of Xaliproden in Reducing the Neurotoxicity of the Oxaliplatin + 5-FU/LV Chemotherapy

NCT ID: NCT00272051

Last Updated: 2006-09-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

620 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-07-31

Study Completion Date

2004-05-31

Brief Summary

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Purpose of the trial is to evaluate the efficacy of Xaliproden in reducing the neurotoxicity of the Oxaliplatin and 5-FU/LV chemotherapy, in patients with metastatic colorectal carcinomaPrimary objectives : Compare the risk of occurence of grade 3-4 peripheral sensory neuropathy relative to the cumulative dose of Oxaliplatin between treatment group and placebo group ; Compare the response rate between treatment group and placebo group.Secondary objectives : neurotoxicity parameters (overall incidence, time and dose to onset, time to recovery, change in the sensory action potentials) ; antitumoral efficacy (progression-free survival, overall survival) ; safety profile.

Detailed Description

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Conditions

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Metastases Colorectal Neoplasms Colorectal Carcinoma

Keywords

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Neurotoxicity syndromes Paresthesia Oxaliplatin Xaliproden

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

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SR57746A

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Histologically or cytologically proven adenocarcinoma of the colon or the rectum
* age \> 18 years
* WHO performance status : 0,1,2
* Signed written informed consent prior to study entry
* Disease stage : metastatic disease not amenable to potentially curative treatment (eg : inoperable metastatic disease)
* Measurable disease
* No prior chemotherapeutic regimen for metastatic disease ; prior adjuvant chemotherapy allowed (disease free interval from end of adjuvant therapy of at least 6 months)
* Prior radiotherapy permitted, if completed at least 3 weeks before randomization, and if not administered to target lesions identified for the study

Exclusion Criteria

* Chemotherapeutic agents other than 5-FU/LV or 5-FU/Levamizole as part of adjuvant therapy
* Prior therapy with Oxaliplatin
* History of cardiac toxicities under 5-FU/LV therapy or myocardial infarction within the 6 months before study entry ; Known Dihydropyrimidine Dehydrogenase deficiency
* History of intolerance to appropriate antiemetics
* Concurrent active cancer originating from a primary site other than colon or rectum
* Presence of any symptom suggesting brain metastasis
* Known peripheral neuropathy
* Interstitial pneumonia or extensive and symptomatic fibrosis of the lung
* Allergy to Xaliproden/excipients
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sanofi

INDUSTRY

Sponsor Role lead

Principal Investigators

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Gérard SAID, MD

Role: STUDY_CHAIR

Hôpital de Bicêtre - Le Kremlin-Bicêtre - France

References

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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.

Reference Type DERIVED
PMID: 36606664 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31378656 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30679026 (View on PubMed)

Related Links

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http://www.sanofi-aventis.com

Related Info

Other Identifiers

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SR57746A

Identifier Type: -

Identifier Source: secondary_id

EFC4972

Identifier Type: -

Identifier Source: org_study_id