Ignite Creation Date:
2025-12-24 @ 10:37 PM
Ignite Modification Date:
2026-01-01 @ 8:16 AM
Study NCT ID:
NCT00084435
Status:
WITHDRAWN
Last Update Posted:
2012-06-14
First Post:
2004-06-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
S0217, Adjuvant Cisplatin and Docetaxel After Complete Resection Stage III or IV 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': 'D012468', 'term': 'Salivary Gland Neoplasms'}, {'id': 'D000077195', 'term': 'Squamous Cell Carcinoma of Head and Neck'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009062', 'term': 'Mouth Neoplasms'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D012466', 'term': 'Salivary Gland Diseases'}, {'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': 'D000077143', 'term': 'Docetaxel'}, {'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': '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': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Poor accrual and suspension of head and neck committee', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2005-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-06', 'completionDateStruct': {'date': '2007-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-06-13', 'studyFirstSubmitDate': '2004-06-10', 'studyFirstSubmitQcDate': '2004-06-10', 'lastUpdatePostDateStruct': {'date': '2012-06-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2004-06-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Disease progression'}, {'measure': 'Disease-free survival'}, {'measure': 'Symptomatic deterioration'}, {'measure': 'Toxicity'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['stage III squamous cell carcinoma of the lip and oral cavity', 'stage IV squamous cell carcinoma of the lip and oral cavity', 'stage III squamous cell carcinoma of the paranasal sinus and nasal cavity', 'stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity', 'stage III salivary gland cancer', 'stage IV salivary gland cancer', 'stage III squamous cell carcinoma of the hypopharynx', 'stage IV squamous cell carcinoma of the hypopharynx', 'stage III squamous cell carcinoma of the larynx', 'stage IV squamous cell carcinoma of the larynx', 'stage III squamous cell carcinoma of the oropharynx', 'stage IV squamous cell carcinoma of the oropharynx', 'salivary gland squamous cell carcinoma'], 'conditions': ['Head and Neck Cancer']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Drugs used in chemotherapy, such as cisplatin and docetaxel, work in 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. Cisplatin and docetaxel may make the tumor cells more sensitive to radiation therapy. Giving chemoradiotherapy after surgery may kill any remaining tumor cells.\n\nPURPOSE: This phase II trial is studying how well adjuvant chemoradiotherapy using cisplatin and docetaxel works in treating patients with completely resected stage III or stage IV head and neck cancer.', 'detailedDescription': 'OBJECTIVES:\n\n* Determine the disease-free survival and overall survival of patients with high-risk stage III or IV squamous cell carcinoma of the head and neck treated with adjuvant chemoradiotherapy comprising docetaxel and cisplatin.\n* Determine the toxicity of this regimen in these patients.\n* Categorize the site(s) of disease relapse in patients treated with this regimen.\n\nOUTLINE: This is a multicenter study.\n\nPatients receive docetaxel IV over 1 hour on days 1, 8, 15, 22, 29, and 36 and cisplatin IV over 1.5 hours on days 1, 22, and 43. Patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, 36-40, and 43-45. Treatment continues in the absence of disease progression or unacceptable toxicity.\n\nPatients are followed every 3 months until disease progression and then every 6 months for up to 3 years from registration.\n\nPROJECTED ACCRUAL: A total of 70 patients will be accrued for this study within 17.5-23.5 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Diagnosis of squamous cell carcinoma of the head and neck\n\n * Selected stage III or IV (no distant metastasis) disease\n\n * The following TNM stages are excluded:\n\n * T3, N0, M0\n * T4a, N0, M0\n * T4b, N3, M0\n * Any T, any N, M1\n* Complete total resection within the past 56 days AND has one or more of the following risk factors:\n\n * Multiple pathologically confirmed lymph node metastases\n * One or more lymph nodes with extracapsular extension of tumor\n * Microscopically positive margin(s) of resection, including mucosal margins and/or soft tissue or deep margins of resection\n* No primary nasopharyngeal carcinoma\n\nPATIENT CHARACTERISTICS:\n\nAge\n\n* 18 and over\n\nPerformance status\n\n* Zubrod 0-1\n\nLife expectancy\n\n* Not specified\n\nHematopoietic\n\n* Absolute neutrophil count ≥ 1,500/mm\\^3\n* Platelet count ≥ 100,000/mm\\^3\n* Hemoglobin ≥ 8.0 g/dL\n\nHepatic\n\n* Bilirubin ≤ 2 times upper limit of normal (ULN)\n* SGOT or SGPT ≤ 1.5 times ULN\n* Alkaline phosphatase ≤ 2.5 times ULN\n\nRenal\n\n* Creatinine ≤ 1.5 mg/dL OR\n* Creatinine clearance ≥ 60 mL/min\n\nOther\n\n* No pre-existing peripheral neuropathy\n* No known history of severe hypersensitiviy reaction to products containing Polysorbate 80\n* No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer currently in complete remission\n* Not pregnant or nursing\n* Fertile patients must use effective contraception\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* Not specified\n\nChemotherapy\n\n* No prior chemotherapy for the malignancy\n\nEndocrine therapy\n\n* Not specified\n\nRadiotherapy\n\n* No prior radiotherapy for the malignancy\n\nSurgery\n\n* See Disease Characteristics\n\nOther\n\n* No concurrent amifostine'}, 'identificationModule': {'nctId': 'NCT00084435', 'acronym': 'S0217', 'briefTitle': 'S0217, Adjuvant Cisplatin and Docetaxel After Complete Resection Stage III or IV Head and Neck Cancer', 'organization': {'class': 'NETWORK', 'fullName': 'SWOG Cancer Research Network'}, 'officialTitle': 'Adjuvant Chemo-RT With Cisplatin (NSC-119875) and Docetaxel (NSC-628503) After Complete Resection of Locally Advanced (Stage III and IV) Squamous Cell Carcinoma of the Head and Neck (SCCHN)', 'orgStudyIdInfo': {'id': 'CDR0000365311'}, 'secondaryIdInfos': [{'id': 'S0217', 'type': 'OTHER', 'domain': 'SWOG'}, {'id': 'U10CA032102', 'link': 'https://reporter.nih.gov/quickSearch/U10CA032102', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'chemoRT after surgery', 'description': 'chemoRT with cisplatin and docetaxel after surgery', 'interventionNames': ['Drug: cisplatin', 'Drug: docetaxel', 'Radiation: radiation therapy']}], 'interventions': [{'name': 'cisplatin', 'type': 'DRUG', 'otherNames': ['platinol'], 'description': '75 mg/m2 IV, Day 1, q 21 days for 3 cycles', 'armGroupLabels': ['chemoRT after surgery']}, {'name': 'docetaxel', 'type': 'DRUG', 'otherNames': ['taxotere'], 'description': '15 mg/m2 IV, Day 1, 1 7 days for 6 doses', 'armGroupLabels': ['chemoRT after surgery']}, {'name': 'radiation therapy', 'type': 'RADIATION', 'otherNames': ['RT'], 'description': '200 cGy/day, Days 1-5, q week for 6 weeks', 'armGroupLabels': ['chemoRT after surgery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90089-9181', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'USC/Norris Comprehensive Cancer Center and Hospital', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '62526', 'city': 'Decatur', 'state': 'Illinois', 'country': 'United States', 'facility': 'Decatur Memorial Hospital Cancer Care Institute', 'geoPoint': {'lat': 39.84031, 'lon': -88.9548}}, {'zip': '62781-0001', 'city': 'Springfield', 'state': 'Illinois', 'country': 'United States', 'facility': 'Regional Cancer Center at Memorial Medical Center', 'geoPoint': {'lat': 39.80172, 'lon': -89.64371}}, {'zip': '66160-7357', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'facility': 'Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}, {'zip': '71130-3932', 'city': 'Shreveport', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Feist-Weiller Cancer Center at Louisiana State University Health Sciences', 'geoPoint': {'lat': 32.52515, 'lon': -93.75018}}, {'zip': '48109-0942', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan Comprehensive Cancer Center', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '39216', 'city': 'Jackson', 'state': 'Mississippi', 'country': 'United States', 'facility': 'University of Mississippi Medical Center', 'geoPoint': {'lat': 32.29876, 'lon': -90.18481}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Saint Louis University Cancer Center', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '28139', 'city': 'Rutherfordton', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Rutherford Hospital', 'geoPoint': {'lat': 35.36929, 'lon': -81.95677}}, {'zip': '45601', 'city': 'Chillicothe', 'state': 'Ohio', 'country': 'United States', 'facility': 'Adena Regional Medical Center', 'geoPoint': {'lat': 39.33312, 'lon': -82.9824}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic Taussig Cancer Center', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '43214-3998', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Riverside Methodist Hospital Cancer Care', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '43215', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'CCOP - Columbus', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '43215', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Grant Riverside Cancer Services', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '43222', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Mount Carmel Health - West Hospital', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '43228', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Doctors Hospital at Ohio Health', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '43015', 'city': 'Delaware', 'state': 'Ohio', 'country': 'United States', 'facility': 'Grady Memorial Hospital', 'geoPoint': {'lat': 40.29867, 'lon': -83.06797}}, {'zip': '44131', 'city': 'Independence', 'state': 'Ohio', 'country': 'United States', 'facility': 'Community Oncology Group at Cleveland Clinic Cancer Center', 'geoPoint': {'lat': 41.36866, 'lon': -81.6379}}, {'zip': '43130', 'city': 'Lancaster', 'state': 'Ohio', 'country': 'United States', 'facility': 'Fairfield Medical Center', 'geoPoint': {'lat': 39.71368, 'lon': -82.59933}}, {'zip': '45750', 'city': 'Marietta', 'state': 'Ohio', 'country': 'United States', 'facility': 'Strecker Cancer Center at Marietta Memorial Hospital', 'geoPoint': {'lat': 39.41535, 'lon': -81.45484}}, {'zip': '43055', 'city': 'Newark', 'state': 'Ohio', 'country': 'United States', 'facility': 'Licking Memorial Cancer Care Program at Licking Memorial Hospital', 'geoPoint': {'lat': 40.05812, 'lon': -82.40126}}, {'zip': '45504', 'city': 'Springfield', 'state': 'Ohio', 'country': 'United States', 'facility': 'Mercy Medical Center', 'geoPoint': {'lat': 39.92423, 'lon': -83.80882}}, {'zip': '45505', 'city': 'Springfield', 'state': 'Ohio', 'country': 'United States', 'facility': 'Community Hospital of Springfield and Clark County', 'geoPoint': {'lat': 39.92423, 'lon': -83.80882}}, {'zip': '43081', 'city': 'Westerville', 'state': 'Ohio', 'country': 'United States', 'facility': "Mount Carmel Cancer Services at Mount Carmel St. Ann's Hospital", 'geoPoint': {'lat': 40.12617, 'lon': -82.92907}}, {'zip': '44691', 'city': 'Wooster', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic - Wooster', 'geoPoint': {'lat': 40.80517, 'lon': -81.93646}}, {'zip': '43701', 'city': 'Zanesville', 'state': 'Ohio', 'country': 'United States', 'facility': 'Genesis - Good Samaritan Hospital', 'geoPoint': {'lat': 39.94035, 'lon': -82.01319}}, {'zip': '29621', 'city': 'Anderson', 'state': 'South Carolina', 'country': 'United States', 'facility': 'AnMed Health Cancer Center', 'geoPoint': {'lat': 34.50344, 'lon': -82.65013}}, {'zip': '29303', 'city': 'Spartanburg', 'state': 'South Carolina', 'country': 'United States', 'facility': 'CCOP - Upstate Carolina', 'geoPoint': {'lat': 34.94957, 'lon': -81.93205}}, {'zip': '29303', 'city': 'Spartanburg', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Gibbs Regional Cancer Center at Spartanburg Regional Medical Center', 'geoPoint': {'lat': 34.94957, 'lon': -81.93205}}], 'overallOfficials': [{'name': 'Prakash C. Neupane, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "St. Mary's Cancer Specialists at St. Mary's Health Center"}, {'name': 'Harold E. Kim, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Barbara Ann Karmanos Cancer Institute'}, {'name': 'Stephen K. Williamson, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Kansas'}, {'name': 'George H. Yoo, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Barbara Ann Karmanos Cancer Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'SWOG Cancer Research Network', 'class': 'NETWORK'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}