Ignite Creation Date:
2025-12-24 @ 11:56 PM
Ignite Modification Date:
2025-12-25 @ 9:53 PM
Study NCT ID:
NCT00272051
Status:
COMPLETED
Last Update Posted:
2006-09-13
First Post:
2006-01-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
XENOX - Evaluation of the Efficacy of Xaliproden in Reducing the Neurotoxicity of the Oxaliplatin + 5-FU/LV Chemotherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009362', 'term': 'Neoplasm Metastasis'}, {'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D020258', 'term': 'Neurotoxicity Syndromes'}, {'id': 'D010292', 'term': 'Paresthesia'}], 'ancestors': [{'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D011041', 'term': 'Poisoning'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D020886', 'term': 'Somatosensory Disorders'}, {'id': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C462299', 'term': 'xaliproden'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 620}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-09', 'completionDateStruct': {'date': '2004-05'}, 'lastUpdateSubmitDate': '2006-09-11', 'studyFirstSubmitDate': '2006-01-03', 'studyFirstSubmitQcDate': '2006-01-03', 'lastUpdatePostDateStruct': {'date': '2006-09-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-01-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical evaluation of peripheral sensory neuropathy using the Oxaliplatin specific scale for dose adjustment : Q2W ; response rate using RECIST criteria : Q8W'}], 'secondaryOutcomes': [{'measure': 'Safety : Q2W ; Nerve conduction studies : Baseline + cycle 12 ; Progression Free Survival : Q8W ; Survival'}]}, 'conditionsModule': {'keywords': ['Neurotoxicity syndromes', 'Paresthesia', 'Oxaliplatin', 'Xaliproden'], 'conditions': ['Metastases', 'Colorectal Neoplasms', 'Colorectal Carcinoma']}, 'referencesModule': {'references': [{'pmid': '36606664', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '31378656', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '30679026', 'type': 'DERIVED', 'citation': '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.'}], 'seeAlsoLinks': [{'url': 'http://www.sanofi-aventis.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically or cytologically proven adenocarcinoma of the colon or the rectum\n* age \\> 18 years\n* WHO performance status : 0,1,2\n* Signed written informed consent prior to study entry\n* Disease stage : metastatic disease not amenable to potentially curative treatment (eg : inoperable metastatic disease)\n* Measurable disease\n* No prior chemotherapeutic regimen for metastatic disease ; prior adjuvant chemotherapy allowed (disease free interval from end of adjuvant therapy of at least 6 months)\n* Prior radiotherapy permitted, if completed at least 3 weeks before randomization, and if not administered to target lesions identified for the study\n\nExclusion Criteria:\n\n* Chemotherapeutic agents other than 5-FU/LV or 5-FU/Levamizole as part of adjuvant therapy\n* Prior therapy with Oxaliplatin\n* History of cardiac toxicities under 5-FU/LV therapy or myocardial infarction within the 6 months before study entry ; Known Dihydropyrimidine Dehydrogenase deficiency\n* History of intolerance to appropriate antiemetics\n* Concurrent active cancer originating from a primary site other than colon or rectum\n* Presence of any symptom suggesting brain metastasis\n* Known peripheral neuropathy\n* Interstitial pneumonia or extensive and symptomatic fibrosis of the lung\n* Allergy to Xaliproden/excipients'}, 'identificationModule': {'nctId': 'NCT00272051', 'briefTitle': 'XENOX - Evaluation of the Efficacy of Xaliproden in Reducing the Neurotoxicity of the Oxaliplatin + 5-FU/LV Chemotherapy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'A Multicenter Randomized Dble-Blind Placebo Controlled Phase III Study of the Efficacy of Xaliproden in Reducing the Neurotoxicity of the Oxaliplatin and 5-FU/LV Combination in First-Line Treatment of Patients With Metastatic Colorectal Carcinoma(MCRC)', 'orgStudyIdInfo': {'id': 'EFC4972'}, 'secondaryIdInfos': [{'id': 'SR57746A'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'SR57746A', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Gérard SAID, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Hôpital de Bicêtre - Le Kremlin-Bicêtre - France'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi', 'class': 'INDUSTRY'}}}}