Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2026-01-10 @ 2:58 PM
Study NCT ID:
NCT00004256
Status:
COMPLETED
Last Update Posted:
2013-11-06
First Post:
2000-01-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sargramostim to Prevent Mucositis in Patients Receiving Radiation Therapy for Laryngeal 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': 'D007822', 'term': 'Laryngeal Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D010039', 'term': 'Otorhinolaryngologic Neoplasms'}, {'id': 'D007818', 'term': 'Laryngeal Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C081222', 'term': 'sargramostim'}, {'id': 'D011878', 'term': 'Radiotherapy'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'primaryPurpose': 'SUPPORTIVE_CARE'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1997-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-08', 'completionDateStruct': {'date': '2006-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-11-05', 'studyFirstSubmitDate': '2000-01-28', 'studyFirstSubmitQcDate': '2003-08-22', 'lastUpdatePostDateStruct': {'date': '2013-11-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-08-25', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['stage I laryngeal cancer', 'stage II laryngeal cancer', 'recurrent laryngeal cancer', 'oral complications', 'radiation toxicity'], 'conditions': ['Head and Neck Cancer', 'Oral Complications', 'Radiation Toxicity']}, 'referencesModule': {'references': [{'pmid': '16823067', 'type': 'RESULT', 'citation': "McAleese JJ, Bishop KM, A'Hern R, Henk JM. Randomized phase II study of GM-CSF to reduce mucositis caused by accelerated radiotherapy of laryngeal cancer. Br J Radiol. 2006 Jul;79(943):608-13. doi: 10.1259/bjr/55190439."}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as sargramostim may protect normal cells from the side effects of radiation therapy.\n\nPURPOSE: Randomized phase II trial to determine the effectiveness of sargramostim in preventing mucositis in patients who are receiving radiation therapy for laryngeal cancer.', 'detailedDescription': 'OBJECTIVES:\n\n* Determine the efficacy of sargramostim (GM-CSF) in reducing the duration and severity of mucositis resulting from accelerated radiotherapy in patients with laryngeal carcinoma.\n* Determine the effect of GM-CSF on quality of life aspects of these patients as assessed by nutritional status, analgesic use, and days in the hospital.\n\nOUTLINE: This is a randomized study.\n\nPatients receive radiotherapy in 16 fractions over 21 days. Patients are randomly allocated to one of two treatment arms before scheduled radiotherapy begins.\n\n* Arm I: Patients receive sargramostim (GM-CSF) SC daily for 14 days beginning on day 14 of the course of radiotherapy.\n* Arm II: Patients do not receive GM-CSF. Patients are followed weekly until mucositis is healed, as well as at weeks 2 and 6 following the end of radiotherapy.\n\nPROJECTED ACCRUAL: A total of 34 patients (17 per arm) will be accrued for this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Diagnosis of laryngeal cancer with intention to treat by radiotherapy using a 16 fraction 3 week scheme\n\n * Stage I or II\n* No known CNS disease\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* 20 to 80\n\nPerformance status:\n\n* WHO 0-1\n\nLife expectancy:\n\n* Not specified\n\nHematopoietic:\n\n* Not specified\n\nHepatic:\n\n* Hepatic function normal\n\nRenal:\n\n* Renal function normal\n\nOther:\n\n* Not pregnant or nursing\n* No serious active infection requiring antibiotic therapy\n* No autoimmune disease\n* No known seizures\n* No psychosocial factors that would preclude study compliance\n* No allergies to sargramostim (GM-CSF)\n* Willingness to cooperate for regular mirror examination of the larynx\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy:\n\n* No concurrent immunotherapy\n\nChemotherapy:\n\n* No concurrent chemotherapy\n\nEndocrine therapy:\n\n* No prior or concurrent corticosteroids\n* No concurrent hormonal therapy\n\nRadiotherapy:\n\n* See Disease Characteristics\n\nSurgery:\n\n* No major organ allografts\n\nOther:\n\n* No other concurrent investigational drugs'}, 'identificationModule': {'nctId': 'NCT00004256', 'briefTitle': 'Sargramostim to Prevent Mucositis in Patients Receiving Radiation Therapy for Laryngeal Cancer', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'Randomised Phase II Study of GM-CSF to Reduce Severity of Mucositis Caused by Accelerated Radiotherapy of Laryngeal Cancer', 'orgStudyIdInfo': {'id': 'CDR0000067503'}, 'secondaryIdInfos': [{'id': 'RMNHS-GMCSF'}, {'id': 'EU-99041'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'sargramostim', 'type': 'BIOLOGICAL'}, {'name': 'quality-of-life assessment', 'type': 'PROCEDURE'}, {'name': 'radiation therapy', 'type': 'RADIATION'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SW3 6JJ', 'city': 'London', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Royal Marsden NHS Trust', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'J.M. Henk, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Royal Marsden NHS Foundation Trust'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Royal Marsden NHS Foundation Trust', 'class': 'OTHER'}}}}