Ignite Creation Date:
2025-12-24 @ 1:02 PM
Ignite Modification Date:
2026-03-21 @ 10:54 PM
Study NCT ID:
NCT03194061
Status:
UNKNOWN
Last Update Posted:
2018-01-19
First Post:
2017-04-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hypofractionated Radiotherapy and Concurrent Cisplatin for Head and Neck Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069473', 'term': 'Radiation Dose Hypofractionation'}], 'ancestors': [{'id': 'D019583', 'term': 'Dose Fractionation, Radiation'}, {'id': 'D011879', 'term': 'Radiotherapy Dosage'}, {'id': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2015-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2019-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-01-17', 'studyFirstSubmitDate': '2017-04-24', 'studyFirstSubmitQcDate': '2017-06-20', 'lastUpdatePostDateStruct': {'date': '2018-01-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To evaluate the rate of patient who could complete the treatment.', 'timeFrame': 'up to 5 years after patient accrual', 'description': 'The treatment is considered completed when patients receive at least 90% of radiation dose (49,5Gy) with a cumulative cisplatin dose of 105mg/m2 or more (3 of 4 cycles) and the treatment duration is inferior to 35 consecutive days.'}, {'measure': 'To evaluate the rate of participants with treatment-related adverse events', 'timeFrame': 'up to 5 years after patient accrual', 'description': 'as assessed by investigators using the CTCAE v4.0 criteria'}], 'secondaryOutcomes': [{'measure': 'Quality of life according to the EORTC C30 questionaire and EORTC H&N 35 (evaluated together)', 'timeFrame': 'up to 18 months from treatment', 'description': 'Frequency and intensity of symptoms as described by patients before treatment (baseline), at the end of treatment, 1 month, 7 months and after 1 year following the treatment.'}, {'measure': 'Response rate', 'timeFrame': 'up to 4 months after patient accrual', 'description': 'as determined by investigators using RECIST v1.1 criteria'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['chemotherapy', 'complication'], 'conditions': ['Radiotherapy; Complications']}, 'referencesModule': {'references': [{'pmid': '30352576', 'type': 'DERIVED', 'citation': 'Jacinto AA, Batalha Filho ES, Viana LS, De Marchi P, Capuzzo RC, Gama RR, Boldrini Junior D, Santos CR, Pinto GDJ, Dias JM, Canton HP, Carvalho R, Radicchi LA, Bentzen S, Zubizarreta E, Carvalho AL. Feasibility of concomitant cisplatin with hypofractionated radiotherapy for locally advanced head and neck squamous cell carcinoma. BMC Cancer. 2018 Oct 23;18(1):1026. doi: 10.1186/s12885-018-4893-5.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate the feasibility of hypofractionated radiation therapy and concomitant chemotherapy with cisplatin for locally advanced head and neck cancer in a high volume brazilian center.', 'detailedDescription': 'To evaluate if concomitant cisplatin and hypofractionated radiation therapy wold be feasible in a brazilian population.\n\nPatients eligibility criteria:\n\nolder than 18 years old Biopsy proven squamous cell carcinoma of oropharynx, larynx and hypopharynx. Stage III an IV, with no distant metastasis. ECOG performance status 0-2. Adequate renal and liver function. Good status for radical treatment\n\nTreatment considered feasible if:\n\n1. Patient receive at least 90% of radiation dose (18 of 20 fractions of 275cGy)\n2. Patients receive at least 3 of 4 weekly cycles of cisplatin (35mg/m2)\n3. Treatment length up to 35 days.\n4. Grade 4 toxicity lower than 25%'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Biopsy proven squamous cell carcinoma of oropharynx, larynx and hypopharynx.\n* Stage III an IV, with no distant metastasis.\n* ECOG performance status 0-2.\n* Adequate renal and liver function.\n* Good status for radical treatment\n\nExclusion Criteria:\n\n* Other oncologic treatment before\n* Distant metastasis\n* History of previous malignancy'}, 'identificationModule': {'nctId': 'NCT03194061', 'acronym': 'HIPOCP', 'briefTitle': 'Hypofractionated Radiotherapy and Concurrent Cisplatin for Head and Neck Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Barretos Cancer Hospital'}, 'officialTitle': 'Hypofractionated Radiotherapy and Concurrent Cisplatin for Locally Advanced Head and Neck Cancer: A Feasibility Trial', 'orgStudyIdInfo': {'id': 'HIPO CP.'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hypofractionated chemoradiation', 'description': '20 fractions of 275cGy and concomitant weekly cisplatin 35mg/m2 x 4 cycles', 'interventionNames': ['Radiation: Hypofractionated Radiotherapy', 'Drug: Weekly cisplatin']}], 'interventions': [{'name': 'Hypofractionated Radiotherapy', 'type': 'RADIATION', 'description': '20 fractions of 275cGy 5 days/week', 'armGroupLabels': ['Hypofractionated chemoradiation']}, {'name': 'Weekly cisplatin', 'type': 'DRUG', 'description': 'Concomitant weekly cisplatin 35mg/m2 x 4 weeks', 'armGroupLabels': ['Hypofractionated chemoradiation']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Alexandre A Jacinto, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Barretos Cancer Hospital'}, {'name': 'Andre Lopes Carvalho, Phd', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Barretos Cancer Hospital'}, {'name': 'Luciano Souza Viana, Phd', 'role': 'STUDY_CHAIR', 'affiliation': 'Barretos Cancer Hospital'}, {'name': 'Pedro de Marchi', 'role': 'STUDY_CHAIR', 'affiliation': 'Barretos Cancer Hospital'}, {'name': 'Eronides Salustiano Batalha', 'role': 'STUDY_CHAIR', 'affiliation': 'Barretos Cancer Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Barretos Cancer Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}