Ignite Creation Date:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2025-12-31 @ 10:06 PM
Study NCT ID:
NCT00006051
Status:
COMPLETED
Last Update Posted:
2021-02-21
First Post:
2000-07-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Combination Chemotherapy Plus Radiation Therapy in Treating Patients With 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'}, {'id': 'D000077195', 'term': 'Squamous Cell Carcinoma of Head and Neck'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D002294', 'term': 'Carcinoma, Squamous Cell'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002945', 'term': 'Cisplatin'}, {'id': 'D005472', 'term': 'Fluorouracil'}, {'id': 'D011878', 'term': 'Radiotherapy'}], 'ancestors': [{'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'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'TREATMENT'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1999-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2005-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-19', 'studyFirstSubmitDate': '2000-07-05', 'studyFirstSubmitQcDate': '2004-03-24', 'lastUpdatePostDateStruct': {'date': '2021-02-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2004-03-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2002-08', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['stage I squamous cell carcinoma of the lip and oral cavity', 'stage II squamous cell carcinoma of the lip and oral cavity', 'stage III squamous cell carcinoma of the lip and oral cavity', 'stage IV squamous cell carcinoma of the lip and oral cavity', 'stage I squamous cell carcinoma of the oropharynx', 'stage II squamous cell carcinoma of the oropharynx', 'stage III squamous cell carcinoma of the oropharynx', 'stage IV squamous cell carcinoma of the oropharynx', 'stage I squamous cell carcinoma of the hypopharynx', 'stage II squamous cell carcinoma of the hypopharynx', 'stage III squamous cell carcinoma of the hypopharynx', 'stage IV squamous cell carcinoma of the hypopharynx', 'stage I squamous cell carcinoma of the larynx', 'stage II squamous cell carcinoma of the larynx', 'stage III squamous cell carcinoma of the larynx', 'stage IV squamous cell carcinoma of the larynx'], 'conditions': ['Head and Neck Cancer']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining more than one chemotherapy drug with radiation therapy may kill more tumor cells.\n\nPURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus radiation therapy in treating patients who have head and neck cancer.', 'detailedDescription': 'OBJECTIVES: I. Determine the toxicity of fluorouracil and cisplatin with concurrent radiotherapy in patients with stage I-IVB squamous cell cancer of the head and neck at high risk of recurrence following curative resection. II. Determine the efficacy of this regimen in these patients. III. Determine the survival of these patients treated with this regimen.\n\nOUTLINE: This is a multicenter study. Patients receive fluorouracil IV continuously on days 1-5 and 43-47 and cisplatin IV over 1 hour on days 2, 23, and 44. Concurrent radiotherapy is administered 5 days a week for 6.5 weeks. Patients are followed every 3 months for 2 years, then every 6 months for 3 years.\n\nPROJECTED ACCRUAL: A total of 44-68 patients will be accrued for this study within 18 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS: Histologically proven stage I-IVB squamous cell cancer of the oral cavity, oropharynx, hypopharynx, or larynx Positive lymph nodes allowed, either bilateral or contralateral Curatively resected within past 6 weeks No distant metastases\n\nPATIENT CHARACTERISTICS: Age: Over 18 to 70 Performance status: Karnofsky 70-100% Life expectancy: Not specified Hematopoietic: WBC at least 2,000/mm3 Platelet count at least 150,000/mm3 Hepatic: Bilirubin less than 1.5 times upper limit of normal (ULN) SGOT and SGPT less than 2 times ULN Alkaline phosphatase less than 2 times ULN Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance greater than 70 mL/min Cardiovascular: No contraindication to fluorouracil IV No coronary artery disease greater than grade 2 No unstable heart disease Other: No other malignancy except basal cell skin cancer or carcinoma in situ of the cervix Not pregnant Fertile patients must use effective contraception\n\nPRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy Surgery: See Disease Characteristics Other: No other concurrent adjuvant therapy No concurrent preventive treatment (e.g., retinoids) No other concurrent experimental treatment'}, 'identificationModule': {'nctId': 'NCT00006051', 'briefTitle': 'Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Head and Neck Cancer', 'organization': {'class': 'OTHER', 'fullName': 'UNICANCER'}, 'officialTitle': 'Combination Chemotherapy Concurrent With Postoperative Radiotherapy Epidermoid Carcinoma of the Head and Neck at High Risk of Recurrence - Study of Feasibility', 'orgStudyIdInfo': {'id': 'CDR0000068073'}, 'secondaryIdInfos': [{'id': 'FRE-FNCLCC-GORTEC98-01/98007'}, {'id': 'EU-20015'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'cisplatin', 'type': 'DRUG'}, {'name': 'fluorouracil', 'type': 'DRUG'}, {'name': 'radiation therapy', 'type': 'RADIATION'}]}, 'contactsLocationsModule': {'locations': [{'zip': '63011', 'city': 'Clermont-Ferrand', 'country': 'France', 'facility': 'Centre Jean Perrin', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}, {'zip': '88021', 'city': 'Épinal', 'country': 'France', 'facility': 'Hopital Jean Monnet', 'geoPoint': {'lat': 48.18324, 'lon': 6.45304}}, {'zip': '44805', 'city': 'Nantes-Saint Herblain', 'country': 'France', 'facility': 'CRLCC Nantes - Atlantique'}, {'zip': '37044', 'city': 'Tours', 'country': 'France', 'facility': 'Centre Hospitalier Universitaire Bretonneau de Tours', 'geoPoint': {'lat': 47.39484, 'lon': 0.70398}}, {'zip': '54511', 'city': 'Vandœuvre-lès-Nancy', 'country': 'France', 'facility': 'Centre Alexis Vautrin', 'geoPoint': {'lat': 48.66115, 'lon': 6.17114}}, {'zip': 'F-94805', 'city': 'Villejuif', 'country': 'France', 'facility': 'Institut Gustave Roussy', 'geoPoint': {'lat': 48.7939, 'lon': 2.35992}}], 'overallOfficials': [{'name': 'Lionnel Geoffrois, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Centre Alexis Vautrin'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'UNICANCER', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}