Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2025-12-26 @ 4:18 AM
Study NCT ID:
NCT00006360
Status:
COMPLETED
Last Update Posted:
2020-10-22
First Post:
2000-10-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Radiation Therapy in Treating Patients With Stage II or Stage III Oropharyngeal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D011832', 'term': 'Radiation Injuries'}, {'id': 'D000077195', 'term': 'Squamous Cell Carcinoma of Head and Neck'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'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': 'D011835', 'term': 'Radiation Protection'}, {'id': 'D011878', 'term': 'Radiotherapy'}], 'ancestors': [{'id': 'D011870', 'term': 'Radiologic Health'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'TREATMENT'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-12', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-21', 'studyFirstSubmitDate': '2000-10-04', 'studyFirstSubmitQcDate': '2003-01-26', 'lastUpdatePostDateStruct': {'date': '2020-10-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2003-01-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Acute salivary gland toxicity'}, {'measure': 'Locoregional control'}, {'measure': 'Whole mouth saliva output relative to pre-radiotherapy measurements'}, {'measure': 'Acute mucositis and other acute and late toxicities'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['stage II squamous cell carcinoma of the oropharynx', 'stage III squamous cell carcinoma of the oropharynx', 'radiation toxicity'], 'conditions': ['Head and Neck Cancer', 'Radiation Toxicity']}, 'referencesModule': {'references': [{'pmid': '17576443', 'type': 'BACKGROUND', 'citation': 'Ploquin N, Lau H, Dunscombe P. Intensity modulated and three-dimensional conformal radiation therapy plans for oropharyngeal cancer: a comparison of their sensitivity to set-up errors and uncertainties. Curr Oncol. 2006 Apr;13(2):61-6. doi: 10.3390/curroncol13020005.'}, {'pmid': '19540060', 'type': 'RESULT', 'citation': 'Eisbruch A, Harris J, Garden AS, Chao CK, Straube W, Harari PM, Sanguineti G, Jones CU, Bosch WR, Ang KK. Multi-institutional trial of accelerated hypofractionated intensity-modulated radiation therapy for early-stage oropharyngeal cancer (RTOG 00-22). Int J Radiat Oncol Biol Phys. 2010 Apr;76(5):1333-8. doi: 10.1016/j.ijrobp.2009.04.011. Epub 2009 Jun 18.'}, {'type': 'RESULT', 'citation': 'Eisbruch A, Harris J, Garden A, et al.: Phase II multi-institutional study of IMRT for oropharyngeal cancer (RTOG 00-22): early results. [Abstract] Int J Radiat Oncol Biol Phys 66 (3 Suppl 1): A-79, S46-7, 2006.'}, {'pmid': '36925074', 'type': 'DERIVED', 'citation': 'Garden AS, Harris J, Eisbruch A, Chao KSC, Morrison WH, Harari PM, Swanson TA, Jones CU, Yom SS, Spencer SA, Scrimger R, Shenouda G, Shukla M, Lau HY, Mierzwa M, Torres-Saavedra P, Le QT. Final Report of NRG Oncology RTOG 0022: A Phase 1/2 Study of Conformal and Intensity Modulated Radiation for Oropharyngeal Cancer. Int J Radiat Oncol Biol Phys. 2023 Oct 1;117(2):333-340. doi: 10.1016/j.ijrobp.2023.02.057. Epub 2023 Mar 15. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells.\n\nPURPOSE: Phase I/II trial to study the effectiveness of radiation therapy in treating patients who have stage II or stage III oropharyngeal cancer.', 'detailedDescription': 'OBJECTIVES:\n\n* Assess target coverage and major salivary gland sparing in patients with stage II or III oropharyngeal cancer treated with intensity-modulated radiotherapy.\n* Determine the nature and prevalence of acute and late side effects of this treatment in these patients.\n* Determine the rate and pattern of locoregional tumor recurrence in these patients after this treatment.\n\nOUTLINE: This is a multicenter study.\n\nPatients receive 3-D conformal radiotherapy and/or intensity-modulated radiotherapy daily 5 days a week for 6 weeks, in an effort to spare major salivary glands.\n\nPatients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.\n\nPROJECTED ACCRUAL: Approximately 57-64 patients will be accrued for this study over 27 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '120 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically proven stage II or III (T1-T2, N0-N1) squamous cell carcinoma of the oropharynx (tonsil, base of tongue, or palate)\n\n * Lymph nodes in both sides of neck at risk of metastatic disease and require radiotherapy\n * Patients upstaged by imaging to N2 are eligible\n* Measurable or evaluable disease\n\n * Greater than 1 cm in one dimension or with necrotic regions if by CT or MRI scan\n* Surgery of the primary tumor or lymph nodes limited to incisional or excisional biopsies\n* No distant metastases\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* Over 18\n\nPerformance status:\n\n* Zubrod 0-1\n\nLife expectancy:\n\n* Not specified\n\nHematopoietic:\n\n* Not specified\n\nHepatic:\n\n* Not specified\n\nRenal:\n\n* Not specified\n\nOther:\n\n* No active untreated infection\n* No other malignancy within the past 5 years except nonmelanoma skin cancer or a carcinoma not of head or neck origin\n* No concurrent major medical or psychiatric illness that would preclude study\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy:\n\n* Not specified\n\nChemotherapy:\n\n* More than 3 months since prior chemotherapy\n* No concurrent chemotherapy\n\nEndocrine therapy:\n\n* Not specified\n\nRadiotherapy:\n\n* No prior head or neck radiotherapy\n\nSurgery:\n\n* See Disease Characteristics\n\nOther:\n\n* No other concurrent treatment for head and neck cancer\n* No prophylactic amifostine or pilocarpine'}, 'identificationModule': {'nctId': 'NCT00006360', 'briefTitle': 'Radiation Therapy in Treating Patients With Stage II or Stage III Oropharyngeal Cancer', 'organization': {'class': 'NETWORK', 'fullName': 'Radiation Therapy Oncology Group'}, 'officialTitle': 'Conformal and Intensity Modulated Irradiation for Oropharyngeal Cancer', 'orgStudyIdInfo': {'id': 'RTOG-0022'}, 'secondaryIdInfos': [{'id': 'CDR0000068231'}, {'id': 'RTOG-H-0022'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'radioprotection', 'type': 'DRUG'}, {'name': 'radiation therapy', 'type': 'RADIATION'}]}, 'contactsLocationsModule': {'locations': [{'zip': '85013', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Foundation for Cancer Research and Education', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '94115', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'UCSF Comprehensive Cancer Center', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '32610-0385', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Florida Shands Cancer Center', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '48109-0010', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan Comprehensive Cancer Center', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '64131', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': 'CCOP - Kansas City', 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '07740-6395', 'city': 'Long Branch', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Monmouth Medical Center', 'geoPoint': {'lat': 40.30428, 'lon': -73.99236}}, {'zip': '08755', 'city': 'Toms River', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Community Regional Cancer Center at Community Medical Center', 'geoPoint': {'lat': 39.95373, 'lon': -74.19792}}, {'zip': '19107-5541', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Kimmel Cancer Center at Thomas Jefferson University - Philadelphia', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '77030-4009', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'M.D. Anderson Cancer Center at University of Texas', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '84143', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'LDS Hospital', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '84770', 'city': 'St. George', 'state': 'Utah', 'country': 'United States', 'facility': 'Dixie Regional Medical Center', 'geoPoint': {'lat': 37.10415, 'lon': -113.58412}}, {'zip': '05701', 'city': 'Rutland', 'state': 'Vermont', 'country': 'United States', 'facility': 'Community Cancer Center at Rutland Regional Medical Center', 'geoPoint': {'lat': 43.61062, 'lon': -72.97261}}, {'zip': '54449', 'city': 'Marshfield', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'CCOP - Marshfield Clinic Research Foundation', 'geoPoint': {'lat': 44.66885, 'lon': -90.1718}}, {'zip': '53226', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Medical College of Wisconsin Cancer Center', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}, {'zip': '53405', 'city': 'Racine', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'All Saints Cancer Center at All Saints Healthcare', 'geoPoint': {'lat': 42.72613, 'lon': -87.78285}}, {'zip': 'T6G 2R7', 'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': "Stollery Children's Hospital at University of Alberta Hospital", 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'zip': 'H2L 4MI', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': "Centre Hospitalier de l'Universite de Montreal", 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'H2W 1S6', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'McGill Cancer Centre at McGill University', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'overallOfficials': [{'name': 'Avraham Eisbruch, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Michigan Rogel Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Radiation Therapy Oncology Group', 'class': 'NETWORK'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}