Ignite Creation Date:
2025-12-24 @ 7:44 PM
Ignite Modification Date:
2025-12-25 @ 5:22 PM
Study NCT ID:
NCT00261703
Status:
COMPLETED
Last Update Posted:
2012-05-11
First Post:
2005-12-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Docetaxel in Head and Neck Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006258', 'term': 'Head and Neck Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077143', 'term': 'Docetaxel'}, {'id': 'D002945', 'term': 'Cisplatin'}, {'id': 'D005472', 'term': 'Fluorouracil'}, {'id': 'D011878', 'term': 'Radiotherapy'}], 'ancestors': [{'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}, {'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 439}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-05', 'completionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-05-10', 'studyFirstSubmitDate': '2005-12-02', 'studyFirstSubmitQcDate': '2005-12-02', 'lastUpdatePostDateStruct': {'date': '2012-05-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-12-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Phase II: Clinical objective response rate, at the end of inducted chemotherapy (groups A and B) and at the end of combined treatment (groups A, B and C).', 'timeFrame': '16 weeks'}, {'measure': 'Phase III: Surveillance with no progression after two years.', 'timeFrame': '2 years'}]}, 'conditionsModule': {'conditions': ['Head and Neck Neoplasms']}, 'referencesModule': {'references': [{'pmid': '32797376', 'type': 'DERIVED', 'citation': 'Hitt R, Iglesias L, Lopez-Pousa A, Berrocal-Jaime A, Grau JJ, Garcia-Giron C, Martinez-Trufero J, Guix M, Lambea-Sorrosal J, Del Barco-Morillo E, Leon-Vintro X, Cunquero-Tomas AJ, Baste N, Ocana A, Cruz-Hernandez JJ; the Spanish Head and Neck Cancer Cooperative Group (TTCC). Long-term outcomes of induction chemotherapy followed by chemoradiotherapy vs chemoradiotherapy alone as treatment of unresectable head and neck cancer: follow-up of the Spanish Head and Neck Cancer Group (TTCC) 2503 Trial. Clin Transl Oncol. 2021 Apr;23(4):764-772. doi: 10.1007/s12094-020-02467-8. Epub 2020 Aug 14.'}, {'pmid': '24256848', 'type': 'DERIVED', 'citation': 'Hitt R, Grau JJ, Lopez-Pousa A, Berrocal A, Garcia-Giron C, Irigoyen A, Sastre J, Martinez-Trufero J, Brandariz Castelo JA, Verger E, Cruz-Hernandez JJ; Spanish Head and Neck Cancer Cooperative Group (TTCC). A randomized phase III trial comparing induction chemotherapy followed by chemoradiotherapy versus chemoradiotherapy alone as treatment of unresectable head and neck cancer. Ann Oncol. 2014 Jan;25(1):216-25. doi: 10.1093/annonc/mdt461. Epub 2013 Nov 19.'}]}, 'descriptionModule': {'briefSummary': 'Primary Objective:\n\n* Phase II: To determine the best treatment scheme (TPF vs. PF).\n* Phase III: To compare the time to progression and the treatment failure at the 3 arms.\n\nSecondary objectives:\n\n* To evaluate the safety at the 3 arms.\n* To compare the progression , overall survival and locoregional control at the 3 arms.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Head and Neck cancer locally advanced (oral cavity, oropharynx, hypopharynx or larynx) but without evident metastasis.\n* Inoperable tumor after revision by a multidisciplinary oncology team.\n* Proved epidermoid carcinoma.\n* ECOG = 0-1\n* Good hematologic function (i.e, hemoglobin \\> 10 g/dl, ...)\n* Good hepatologic function\n* Good renal function\n\nExclusion Criteria:\n\n* Pregnant or breast-feeding women. Potential child-bearing women should use an effective conceptive method and should have a negative pregnancy test at least the week before entering the study.\n* Nasopharynx, nasal cavity and paranasal sinusitis will be excluded\n* Previous chemotherapeutic or radiotherapeutic treatment for this disease.\n* Previous or current neoplasms in other locations, except in situ cervicouterine cancer properly treated or basal cell or squamous cell carcinoma\n* Symptomatic peripheral neuropathy\n* Other clinical severe diseases\n* Concomitant treatment with corticoids within 6 months prior to inclusion.\n* Concomitant treatment with any other neoplastic therapy\n* Previous treatment for current disease.\n* Loss of weight greater than 10% within the last 3 months.\n\nThe above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial."}, 'identificationModule': {'nctId': 'NCT00261703', 'briefTitle': 'Docetaxel in Head and Neck Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'Randomized Phase III Trial Comparing Induction Chemotherapy With Cisplatin/5-fluorouracil (PF) or Docetaxel/Cisplatin/5-fluorouracil (TPF) Plus Chemoradiotherapy (CRT) Versus CRT Alone as First-line Treatment or Unresectable Locally Advanced Head and Neck Cancer (LAHNC).', 'orgStudyIdInfo': {'id': 'XRP6976F_2503'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': '(Docetaxel + Cisplatin + 5-FU) + Cisplatin + Radiotherapy', 'interventionNames': ['Drug: Docetaxel, Cisplatin, 5-fluorouracil (5-FU), radiotherapy']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': '(Cisplatin + 5-FU) + Cisplatin + Radiotherapy', 'interventionNames': ['Drug: Cisplatin, 5-fluorouracil (5-FU), radiotherapy']}, {'type': 'EXPERIMENTAL', 'label': '3', 'description': 'Cisplatin + Radiotherapy', 'interventionNames': ['Other: Cisplatin + radiotherapy']}], 'interventions': [{'name': 'Docetaxel, Cisplatin, 5-fluorouracil (5-FU), radiotherapy', 'type': 'DRUG', 'description': 'Docetaxel 75 mg/m2, Day 1 of the cycle + Cisplatin 75 mg/m2 Day 1 + 5-FU 750 mg/m2/day in 24-h continuous infusion for 5 days. 3 cycles will be administered, every 21 days, before the local-regional treatment (same as control group)', 'armGroupLabels': ['1']}, {'name': 'Cisplatin, 5-fluorouracil (5-FU), radiotherapy', 'type': 'DRUG', 'description': 'Cisplatin 100 mg/m2 Day 1, 5-FU 1000 mg/m2/day in 24-h continuous infusion for 5 consecutive days. 3 cycles will be administered every 21 days, before the local-regional treatment (same as control group)', 'armGroupLabels': ['2']}, {'name': 'Cisplatin + radiotherapy', 'type': 'OTHER', 'description': 'Cisplatin 100 mg/m2 on days 1, 22 and 43 simultaneously with radiotherapy (2 Gy x 1/day, 5 days per week for 7 weeks-tumor- and 2 Gy x 1/day, 5 days per week for 6 weeks- lymph nodes)', 'armGroupLabels': ['3']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Porto Salvo', 'country': 'Portugal', 'facility': 'Sanofi-Aventis', 'geoPoint': {'lat': 38.72293, 'lon': -9.30473}}, {'city': 'Barcelona', 'country': 'Spain', 'facility': 'Sanofi-Aventis', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}], 'overallOfficials': [{'name': 'JOSÉ Mª TABOADA', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sanofi'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}