Ignite Creation Date:
2025-12-25 @ 3:46 AM
Ignite Modification Date:
2025-12-26 @ 2:33 AM
Study NCT ID:
NCT00002702
Status:
UNKNOWN
Last Update Posted:
2013-08-26
First Post:
1999-11-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Surgery and Radiation Therapy With or Without Interleukin-2 in Treating Patients With Cancer of the Mouth or Oropharynx
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'}, {'id': 'D014062', 'term': 'Tongue Neoplasms'}], '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'}, {'id': 'D009062', 'term': 'Mouth Neoplasms'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D014060', 'term': 'Tongue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C082598', 'term': 'aldesleukin'}, {'id': 'D017024', 'term': 'Chemotherapy, Adjuvant'}, {'id': 'D020360', 'term': 'Neoadjuvant Therapy'}, {'id': 'D011878', 'term': 'Radiotherapy'}], 'ancestors': [{'id': 'D003131', 'term': 'Combined Modality Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004358', 'term': 'Drug Therapy'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 260}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '1992-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-02', 'lastUpdateSubmitDate': '2013-08-23', 'studyFirstSubmitDate': '1999-11-01', 'studyFirstSubmitQcDate': '2003-01-26', 'lastUpdatePostDateStruct': {'date': '2013-08-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-01-27', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Disease-free survival at 3 and 5 years'}, {'measure': 'Recurrence/metastasis rate at 3 and 5 years'}, {'measure': 'Response rate'}, {'measure': 'Local and systemic effects of treatment'}]}, 'conditionsModule': {'keywords': ['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 II squamous cell carcinoma of the oropharynx', 'stage III squamous cell carcinoma of the oropharynx', 'stage IV squamous cell carcinoma of the oropharynx', 'tongue cancer'], 'conditions': ['Head and Neck Cancer']}, 'descriptionModule': {'briefSummary': "RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill cancer cells of the mouth or oropharynx. Radiation therapy uses high-energy x-rays to damage tumor cells. It is not known whether giving interleukin-2 with surgery and radiation therapy is more effective than surgery and radiation therapy alone.\n\nPURPOSE: This randomized phase III trial is studying surgery and radiation therapy alone to see how well they work compared to surgery, radiation therapy, and interleukin-2 in treating patients with cancer of the mouth or oropharynx.", 'detailedDescription': 'OBJECTIVES:\n\n* Compare the disease-free and overall survival in patients with previously untreated squamous cell carcinoma of the oral cavity or oropharynx treated with resection with or without and neoadjuvant and adjuvant perilymphatic interleukin-2 (IL-2) and radiotherapy.\n* Compare the response rate in patients treated with these regimens.\n* Determine the local and systemic effects of locoregional IL-2 on host-tumor interaction and immune properties in these patients.\n\nOUTLINE: This is a randomized, multicenter study. Patients are stratified according to center and tumor stage (T2, N0-2 vs T2, N3 or T3-4, N0-3). Patients are randomized to 1 of 2 treatment arms.\n\n* Arm I: Patients undergo induction comprising interleukin-2 (IL-2) via perilymphatic injections to the ipsilateral myelohyoid muscle and insertion of the sternocleidomastoid muscle on days 1-5 and 8-12. Within 10 days after the last IL-2 injection, patients undergo en bloc resection of the primary tumor and corresponding lymphatic drainage area and pre-study margins. Beginning within 4 weeks after surgery, patients with T2, N0-3 disease but with pathohistological evidence of node invasion or capsular rupture of node metastasis or T3-4, N0-3 disease undergo adjuvant radiotherapy 5 days a week for 4.5-6.5 weeks. Beginning within 4 weeks after surgery or radiotherapy (if applicable), patients receive adjuvant IL-2 via perilymphatic injections to the contralateral myelohyoid muscle and insertion of the sternocleidomastoid muscle on days 1-5. Adjuvant IL-2 continues monthly for at least 1 year in the absence of disease progression.\n* Arm II: Patients undergo resection and radiotherapy (if eligible) as in arm I. Patients are followed monthly for 1 year and then every 2 months for 2 years.\n\nPROJECTED ACCRUAL: A total of 260 patients (130 per treatment arm) will be accrued for this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically proven squamous cell carcinoma of the oral cavity or oropharynx\n\n * Operable, primary, unilateral, stage T2-4, N0-3, M0 disease\n * No high probability of bilateral lymphatic spread (requirement for bilateral neck dissection)\n* No tumor involvement of the following sites:\n\n * Pterygopalatine fossa\n * Carotid artery\n * Maxillary sinus\n * Facial skin\n * Anterior floor of the mouth\n * Base of the tongue infiltrating more than 1 cm\n* Measurable or evaluable disease by physical exam and/or noninvasive imaging\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* 75 and under\n\nPerformance status:\n\n* ECOG 0-2 OR\n* Karnofsky 70-100%\n\nLife expectancy:\n\n* More than 3 months\n\nHematopoietic:\n\n* WBC at least 4,000/mm3\n* Platelet count at least 60,000/mm3\n* Hematocrit at least 30%\n\nHepatic:\n\n* Bilirubin normal\n* Hepatitis B surface antigen negative\n\nRenal:\n\n* Creatinine normal\n\nCardiovascular:\n\n* No congestive heart failure\n* No uncontrolled hypertension\n* No coronary artery disease\n* No serious arrhythmia\n* No evidence of prior myocardial infarction on ECG (stress test required if in doubt)\n\nOther:\n\n* HIV negative\n* No autoimmune disease\n* No contraindications to pressor agents\n* No serious infection requiring antibiotics\n* No other concurrent primary malignancy\n* Not pregnant or nursing\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy:\n\n* No prior or other concurrent immunotherapy\n\nChemotherapy:\n\n* No prior or concurrent chemotherapy\n\nEndocrine therapy:\n\n* No prior or concurrent hormonal therapy\n* No concurrent corticosteroids\n\nRadiotherapy:\n\n* No prior radiotherapy\n\nSurgery:\n\n* See Disease Characteristics\n* No prior major organ allografts\n\nOther:\n\n* No other prior therapy\n* No other concurrent investigational drugs, agents, or devices\n* No concurrent nonsteroidal antiinflammatory drugs, ranitidine, cimetidine, or coumarin'}, 'identificationModule': {'nctId': 'NCT00002702', 'briefTitle': 'Surgery and Radiation Therapy With or Without Interleukin-2 in Treating Patients With Cancer of the Mouth or Oropharynx', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'Multicentre Randomised Trial of Inductive and Adjuvant Perilymphatically Injected Proleukin (rlL-2) in The Treatment of Operable Primary Squamous Cell Carcinoma of The Oral Cavity and Oropharynx', 'orgStudyIdInfo': {'id': 'CDR0000064500'}, 'secondaryIdInfos': [{'id': 'CNR-9506'}, {'id': 'EU-95024'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'aldesleukin', 'type': 'BIOLOGICAL'}, {'name': 'adjuvant therapy', 'type': 'PROCEDURE'}, {'name': 'conventional surgery', 'type': 'PROCEDURE'}, {'name': 'neoadjuvant therapy', 'type': 'PROCEDURE'}, {'name': 'radiation therapy', 'type': 'RADIATION'}]}, 'contactsLocationsModule': {'locations': [{'zip': '70124', 'city': 'Bari', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'G. Cervellera, MD', 'role': 'CONTACT', 'phone': '39-080-5478-660'}], 'facility': 'Universita Degli Studi di Bari', 'geoPoint': {'lat': 41.12066, 'lon': 16.86982}}, {'zip': '09042', 'city': 'Cagliari', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'P. Puxeddu, MD', 'role': 'CONTACT', 'phone': '39-070-5109-6253'}], 'facility': 'Cattedra di Oncologia Medica - Universita degli Studi di Cagliari', 'geoPoint': {'lat': 39.23054, 'lon': 9.11917}}, {'zip': '44100', 'city': 'Ferrara', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'C. Calearo, MD', 'role': 'CONTACT', 'email': 'ccv@dns.unife.it', 'phone': '39-0532-209-296'}], 'facility': 'Universita di Ferrara', 'geoPoint': {'lat': 44.83804, 'lon': 11.62057}}, {'zip': '50134', 'city': 'Florence', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'O. Fini-Storchi, MD', 'role': 'CONTACT', 'phone': '39-55-411739'}], 'facility': 'Universita Degli Studi di Florence - Policlinico di Careggi', 'geoPoint': {'lat': 43.77925, 'lon': 11.24626}}, {'zip': '10126', 'city': 'Turin', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'G. Valente, MD', 'role': 'CONTACT', 'phone': '39-011-670-5955'}], 'facility': 'Universita di Torino', 'geoPoint': {'lat': 45.07049, 'lon': 7.68682}}, {'zip': '10128', 'city': 'Turin', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'G. Forni, MD', 'role': 'CONTACT', 'phone': '39-11-508-1111'}], 'facility': 'Azienda Sanitaria Ospedaliera Ordine Mauriziano', 'geoPoint': {'lat': 45.07049, 'lon': 7.68682}}, {'zip': '36100', 'city': 'Vicenza', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'C. Curioni, MD', 'role': 'CONTACT', 'phone': '39-444-993-906'}], 'facility': 'Ospedale San Bortolo', 'geoPoint': {'lat': 45.54672, 'lon': 11.5475}}], 'overallOfficials': [{'name': 'Giorgio Cortesina, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Universita Degli Studi di Turin'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'European Institute of Oncology', 'class': 'OTHER'}}}}