Ignite Creation Date:
2025-12-25 @ 12:40 AM
Ignite Modification Date:
2026-01-03 @ 2:28 PM
Study NCT ID:
NCT03370367
Status:
COMPLETED
Last Update Posted:
2023-06-15
First Post:
2017-12-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Double Blind Phase III Trial of Effects of Low Dose 13-Cisretinoic Acid on Prevention of Second Primaries in Stages I-II Head and Neck Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006258', 'term': 'Head and Neck Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015474', 'term': 'Isotretinoin'}], 'ancestors': [{'id': 'D012176', 'term': 'Retinoids'}, {'id': 'D002338', 'term': 'Carotenoids'}, {'id': 'D011090', 'term': 'Polyenes'}, {'id': 'D000475', 'term': 'Alkenes'}, {'id': 'D006839', 'term': 'Hydrocarbons, Acyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D053138', 'term': 'Cyclohexenes'}, {'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D010860', 'term': 'Pigments, Biological'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 189}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1989-05-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2015-04-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-13', 'studyFirstSubmitDate': '2017-12-07', 'studyFirstSubmitQcDate': '2017-12-11', 'lastUpdatePostDateStruct': {'date': '2023-06-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-12-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '1999-01-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The time to diagnosis of second primary for the treatment versus control groups.', 'timeFrame': '20 years'}], 'secondaryOutcomes': [{'measure': 'Survival time for the treatment versus control groups.', 'timeFrame': '20 years'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stage I-II Head and Neck Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://nctn-data-archive.nci.nih.gov/', 'label': 'Data Available: Select individual patient-level data from this trial can be requested from the NCTN/NCORP Data Archive.'}]}, 'descriptionModule': {'briefSummary': 'In this trial the investigators propose to utilize 13-cRA to prevent dysplastic changes and second malignancies in patients with squamous cell carcinoma of the head and neck regions who have a high probability of cure from their primary cancer. Comparisons between patients treated by 13-cRA and patients receiving placebo will include:\n\n1. The time to diagnosis of second primary for the treatment versus control groups.\n2. Survival time for the treatment versus control groups.\n3. Secondarily, the cost-benefit ratio for 13-cRA will be analyzed by assessing the toxicities of 13-cis retinoic acid treated patients in comparison to those experienced by placebo treated patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Informed consent i obtained, the approved form is signed, and on file at the institution.\n* Histologically confirmed squamous cell carcinoma.\n* All chest x-rays and cervical spine x-rays done after definitive treatment within 35 days prior to randomization and all hematology andchemistries done within 2 weeks prior to randomization.\n* The following sites and stages of cancers will be eligible. Oral Cavity\n\n 1. T1 NO\n 2. T2 NO 3.142 Oropharynx\n\n <!-- -->\n\n 1. T1 NO\n 2. T2 NO 3.143 Hypopharynx\n\n 1\\. T1 NO 3.144 Larynx\n 1. T1 NO\n 2. T2 NO\n* Age greater than 18 years.\n* ECOG performance status 0 or 1.\n* Patients must have adequate bone marrow, hepatic and renal function defined as follows: WBC \\>3,500/mm, Platelets \\> 125,000/mm.3 Total Bilirubin \\< 2 mg%, Serum creatinine \\< 2.5 mg%. Serum SGOT \\< 2x normal, Alkaline Phosphatase \\< 2x normal. Fasting Serum triglyceride levels \\< 210 mg %. Fasting cholesterol \\< 350 mg %. Patient may not be under systemic therapy for hyperlipidemia or have symptomatic arteriosclerotic coronary artery disease or have undergone coronary bypass surgery.\n* The patient must have completed primary treatment of their cancer with surgery and/or radiation therapy within 730 days prior to randomization.\n* The patient has had surgery and/or radiation therapy as outlined in Sections 5.0 and 6.0, and has been rendered disease-free.\n* If currently receiving, patient must discontinue mega vitamin doses\n\nExclusion Criteria:\n\n* Women of child bearing potential.\n* Patient with severe coronary artery disease (Class III-IV New York Heart Association.)\n* Histology other than squamous cell carcinoma.\n* Distant metastases.\n* Completion of previous treatment for their primary cancer with radiation, or surgery (except for biopsy) more than 730 days ago.\n* Prior, synchronous, or concurrent malignancy except basal cell skin cancer.\n* Failure to be rendered disease-free of primary tumor (includes positive surgical margins).\n* The patient has had prior therapy other than that outlined in Sections 5.0 and 6.0 of the protocol.'}, 'identificationModule': {'nctId': 'NCT03370367', 'briefTitle': 'Double Blind Phase III Trial of Effects of Low Dose 13-Cisretinoic Acid on Prevention of Second Primaries in Stages I-II Head and Neck Cancer', 'organization': {'class': 'NETWORK', 'fullName': 'Eastern Cooperative Oncology Group'}, 'officialTitle': 'Double Blind Phase III Trial of Effects of Low Dose 13-Cisretinoic Acid on Prevention of Second Primaries in Stages I-II Head and Neck Cancer', 'orgStudyIdInfo': {'id': 'C0590'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm A', 'description': '13-cis retinoic acid will be dispensed in 3.75 mg and 5 mg gelatin capsules. Take 2 capsules once a day for up to 2 years.', 'interventionNames': ['Drug: 13-cis retinoic acid']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Arm B', 'description': 'Take 2 placebo pills once a day for up to 2 years.', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': '13-cis retinoic acid', 'type': 'DRUG', 'description': 'Taken daily.', 'armGroupLabels': ['Arm A']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Placebo', 'armGroupLabels': ['Arm B']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eastern Cooperative Oncology Group', 'class': 'NETWORK'}, 'responsibleParty': {'type': 'SPONSOR'}}}}