Ignite Creation Date:
2025-12-25 @ 2:19 AM
Ignite Modification Date:
2025-12-26 @ 4:09 PM
Study NCT ID:
NCT00004234
Status:
COMPLETED
Last Update Posted:
2020-04-06
First Post:
2000-01-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Oral Mucositis in Patients Receiving Radiation Therapy for Cancer of the Mouth, Pharynx, or Larynx
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': 'D011878', 'term': 'Radiotherapy'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'primaryPurpose': 'SUPPORTIVE_CARE'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1999-08-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2009-02-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-02', 'studyFirstSubmitDate': '2000-01-28', 'studyFirstSubmitQcDate': '2003-01-26', 'lastUpdatePostDateStruct': {'date': '2020-04-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2003-01-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-03-11', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['oral complications', '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', 'recurrent 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', 'recurrent squamous cell carcinoma of the oropharynx', 'stage I squamous cell carcinoma of the nasopharynx', 'stage II squamous cell carcinoma of the nasopharynx', 'stage III squamous cell carcinoma of the nasopharynx', 'stage IV squamous cell carcinoma of the nasopharynx', 'recurrent squamous cell carcinoma of the nasopharynx', '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', 'recurrent 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', 'recurrent squamous cell carcinoma of the larynx'], 'conditions': ['Head and Neck Cancer', 'Oral Complications']}, 'referencesModule': {'references': [{'pmid': '18805649', 'type': 'RESULT', 'citation': 'Bjarnason GA, Mackenzie RG, Nabid A, Hodson ID, El-Sayed S, Grimard L, Brundage M, Wright J, Hay J, Ganguly P, Leong C, Wilson J, Jordan RC, Walker M, Tu D, Parulekar W; National Cancer Institute of Canada Clinical Trials Group (HN3). Comparison of toxicity associated with early morning versus late afternoon radiotherapy in patients with head-and-neck cancer: a prospective randomized trial of the National Cancer Institute of Canada Clinical Trials Group (HN3). Int J Radiat Oncol Biol Phys. 2009 Jan 1;73(1):166-72. doi: 10.1016/j.ijrobp.2008.07.009. Epub 2008 Sep 19.'}, {'type': 'RESULT', 'citation': 'Bjarnason GA, MacKenzie R, Hodson I, et al.: A randomized prospective phase-III study comparing the acute oral mucositis of morning vs. afternoon radiotherapy (RT) in patients (pts) with squamous cell carcinoma of the head and neck (SCCHN): NCIC-CTG HN.3. [Abstract] J Clin Oncol 23 (Suppl 16): A-LBA5500, 500s, 2005 .'}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Giving radiation therapy at different times of the day may affect the chance of developing side effects such as mucositis.\n\nPURPOSE: Randomized phase III trial to compare the incidence of mucositis in patients who have cancer of the mouth, pharynx, or larynx, who are receiving radiation therapy in either the morning or afternoon.', 'detailedDescription': 'OBJECTIVES:\n\n* Compare the toxicity of radiotherapy to the oral mucosa delivered in the morning or in the late afternoon in patients with squamous cell carcinoma of the oral cavity, pharynx (oro/hypo/naso), or larynx who will receive radiation treatment to a significant part of the oral and/or oropharyngeal mucosa.\n\nOUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, intended smoking behavior during therapy (smoking vs nonsmoking), and planned total radiotherapy dose.\n\nPatients are randomized to receive radiotherapy once daily, 5 days a week, at one of two of the following times of the day:\n\n* Arm I: Patients receive radiotherapy between 8 and 10 AM (local time).\n* Arm II: Patients receive radiotherapy between 4 and 6 PM (local time). Treatment continues for 5-8 weeks, depending on planned total radiotherapy dose, in the absence of unacceptable toxicity or disease progression.\n\nToxicity is assessed at baseline, at the first fraction of radiotherapy, weekly during treatment, weekly until mucositis has peaked and is improving, and then every 2 weeks until mucositis has improved to less than grade 2.\n\nQuality of life is assessed at baseline, weekly during treatment and until toxicity has peaked and is improving, every 2 weeks until toxicity is less than grade 2 mucositis, and then at each follow-up visit until week 24.\n\nPatients are followed at weeks 2-3, 6-8, 12, and 24 and then annually for 3 years.\n\nPROJECTED ACCRUAL: A total of 216 patients (108 per treatment arm) will be accrued for this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '120 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically or cytologically confirmed squamous cell carcinoma of the oral cavity, pharynx (oropharynx, hypopharynx, or nasopharynx), or larynx eligible for radical radiotherapy\n\n * TX, T1-4, NX, N0-3, M0\n * Directly visible area of mucosa including 2 or more protocol specified anatomical locations in the radical target volume\n\n * At least 6 cm\\^2 in area irrespective of shape\n * No M1 disease\n* Intention to deliver radiotherapy to a radical dose without chemotherapy\n* May have had surgical resection of the primary or neck nodes\n\n * Postoperative macroscopic or microscopic residual disease that is eligible for radical radiotherapy is allowed\n * Patients with completely resected disease who are judged to be at high risk of relapse and who are eligible for radical radiotherapy are allowed\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* 16 and over\n\nPerformance status:\n\n* ECOG 0-1\n\nLife expectancy:\n\n* Not specified\n\nHematopoietic:\n\n* Hemoglobin ≥ 10 g/dL\n* Granulocyte count ≥ 1,500/mm\\^3\n* Platelet count ≥ 100,000/mm\\^3\n\nHepatic:\n\n* Not specified\n\nRenal:\n\n* Not specified\n\nOther:\n\n* Not pregnant or nursing\n* Fertile patients must use effective contraception\n* HIV negative\n* Must have normal sleeping habits (i.e., normal circadian rhythm)\n* Must have had dental assessment and necessary prophylactic dental extractions carried out\n* No connective tissue diseases (e.g., systemic lupus, scleroderma, mixed connective tissue disease, rheumatoid arthritis)\n* No organic brain syndrome related to chronic alcohol excess or other cause of sufficient severity that would preclude cooperation with treatment\n* No active uncontrolled infection\n* No history of psychiatric or neurological disorder that would preclude study compliance\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy:\n\n* Not specified\n\nChemotherapy:\n\n* See Disease Characteristics\n* At least 6 months since prior chemotherapy\n\nEndocrine therapy:\n\n* Not specified\n\nRadiotherapy:\n\n* See Disease Characteristics\n* No prior radiotherapy to the head and neck region\n\nSurgery:\n\n* See Disease Characteristics\n\nOther:\n\n* No other concurrent oral hygiene regimen other than that described in the protocol\n* No concurrent radioprotective drugs or therapy'}, 'identificationModule': {'nctId': 'NCT00004234', 'briefTitle': 'Oral Mucositis in Patients Receiving Radiation Therapy for Cancer of the Mouth, Pharynx, or Larynx', 'organization': {'class': 'NETWORK', 'fullName': 'Canadian Cancer Trials Group'}, 'officialTitle': 'A Comparison of Acute Oral Mucositis Between Morning and Afternoon Radiotherapy in Patients Receiving Radiation Treatment for Cancer of the Head and Neck', 'orgStudyIdInfo': {'id': 'HN3'}, 'secondaryIdInfos': [{'id': 'CAN-NCIC-HN3', 'type': 'OTHER', 'domain': 'PDQ'}, {'id': 'CDR0000067478', 'type': 'OTHER', 'domain': 'PDQ'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'management of therapy complications', 'type': 'PROCEDURE'}, {'name': 'radiation therapy', 'type': 'RADIATION'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'V1Y 5L3', 'city': 'Kelowna', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'British Columbia Cancer Agency - Centre for the Southern Interior', 'geoPoint': {'lat': 49.88307, 'lon': -119.48568}}, {'zip': 'V3V 1Z2', 'city': 'Surrey', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Fraser Valley Centre at Surrey Memorial Hospital', 'geoPoint': {'lat': 49.10635, 'lon': -122.82509}}, {'zip': 'V5Z 4E6', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'British Columbia Cancer Agency', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'R3E 0V9', 'city': 'Winnipeg', 'state': 'Manitoba', 'country': 'Canada', 'facility': 'CancerCare Manitoba', 'geoPoint': {'lat': 49.8844, 'lon': -97.14704}}, {'zip': 'A1B 3V6', 'city': "St. John's", 'state': 'Newfoundland and Labrador', 'country': 'Canada', 'facility': 'Newfoundland Cancer Treatment and Research Foundation', 'geoPoint': {'lat': 47.56494, 'lon': -52.70931}}, {'zip': 'L8V 5C2', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Margaret and Charles Juravinski Cancer Centre', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'zip': 'N6A 4L6', 'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Cancer Care Ontario-London Regional Cancer Centre', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}, {'zip': 'K1H 1C4', 'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Ottawa Regional Cancer Centre', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}, {'zip': 'P7B 6V4', 'city': 'Thunder Bay', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Regional Cancer Care at Thunder Bay Regional Health Sciences Centre', 'geoPoint': {'lat': 48.38202, 'lon': -89.25018}}, {'zip': 'M4N 3M5', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Toronto Sunnybrook Regional Cancer Centre', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'J1H 5N4', 'city': 'Fleurimont', 'state': 'Quebec', 'country': 'Canada', 'facility': 'CHUS-Hopital Fleurimont', 'geoPoint': {'lat': 45.40842, 'lon': -71.83796}}, {'zip': 'H2W 1S6', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'McGill Cancer Centre', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'G1R 2J6', 'city': 'Québec', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Centre Hospitalier Universitaire de Quebec', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}, {'zip': 'S7N 4H4', 'city': 'Saskatoon', 'state': 'Saskatchewan', 'country': 'Canada', 'facility': 'Saskatoon Cancer Centre', 'geoPoint': {'lat': 52.13238, 'lon': -106.66892}}], 'overallOfficials': [{'name': 'Georg A. Bjarnason, MD, FRCPC', 'role': 'STUDY_CHAIR', 'affiliation': 'Toronto Sunnybrook Regional Cancer Centre'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NCIC Clinical Trials Group', 'class': 'NETWORK'}, 'responsibleParty': {'type': 'SPONSOR'}}}}