Ignite Creation Date:
2025-12-25 @ 3:47 AM
Ignite Modification Date:
2025-12-26 @ 2:35 AM
Study NCT ID:
NCT03435302
Status:
UNKNOWN
Last Update Posted:
2018-02-19
First Post:
2014-02-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
HDI Versus Chemotherapy as Systemic Adjuvant Therapy for Resected Mucosal Melanoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008545', 'term': 'Melanoma'}], 'ancestors': [{'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D018326', 'term': 'Nevi and Melanomas'}, {'id': 'D012878', 'term': 'Skin Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077204', 'term': 'Temozolomide'}, {'id': 'D002945', 'term': 'Cisplatin'}, {'id': 'D007438', 'term': 'Introns'}], 'ancestors': [{'id': 'D003606', 'term': 'Dacarbazine'}, {'id': 'D014226', 'term': 'Triazenes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}, {'id': 'D021901', 'term': 'DNA, Intergenic'}, {'id': 'D040481', 'term': 'Genome Components'}, {'id': 'D016678', 'term': 'Genome'}, {'id': 'D040342', 'term': 'Genetic Structures'}, {'id': 'D055614', 'term': 'Genetic Phenomena'}, {'id': 'D040461', 'term': 'Gene Components'}, {'id': 'D005796', 'term': 'Genes'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 204}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2019-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-02-09', 'studyFirstSubmitDate': '2014-02-08', 'studyFirstSubmitQcDate': '2018-02-09', 'lastUpdatePostDateStruct': {'date': '2018-02-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Relapse-free survival (RFS) of high-dose IFN-a2b (HDI) and temozolomide-based chemotherapy as adjuvant therapy for resected mucosal melanoma.', 'timeFrame': 'Participants will be followed for an expected average of 24 months'}], 'secondaryOutcomes': [{'measure': 'Distant metastasis-free survival(DMFS) of high-dose IFN-a2b (HDI) and temozolomide-based chemotherapy as adjuvant therapy for resected mucosal melanoma.', 'timeFrame': 'Participants will be followed for an expected average of 24 months'}, {'measure': 'Overall survival (OS) of high-dose IFN-a2b (HDI) and temozolomide-based chemotherapy as adjuvant therapy for resected mucosal melanoma.', 'timeFrame': 'From date of randomization until the date of death from any cause, assessed up to 48 months'}, {'measure': 'Number of Participants with Adverse Events of high-dose IFN-a2b (HDI) and temozolomide-based chemotherapy as adjuvant therapy for resected mucosal melanoma', 'timeFrame': 'Participants will be followed for the duration of hospital stay, an expected average of 12 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Mucosal Melanoma,Adjuvant Therapy,IFN-a2b,Temozolomide'], 'conditions': ['Melanoma']}, 'descriptionModule': {'briefSummary': 'This is a a multicenter, randomized, controlled, phase III trial comparing High-Dose IFN-a2b with Temozolomide Plus Cisplatin as Systemic Adjuvant Therapy for Resected Mucosal Melanoma.The study objective is to compare efficacy and safety of High-dose IFN-a2b and temozolomide-based chemotherapy as adjuvant therapy.', 'detailedDescription': 'The patients who comply with the inclusion and exclusion criteria will be enrolled. The estimated recruiting duration is 36 months. Patients with resected mucosal melanoma were randomized into two groups: HDI group (group A, treated with i.v. 15×10\\^6U/m\\^2/d IFN-a2b on days 1 to 5 each week for 4 weeks, followed by s.c. 9×10\\^6U IFN-a2b three times per week for 48 weeks), and chemotherapy group (group B, per os 200 mg/m\\^2/d temozolomide on days 1 to 5 plus i.v. 75 mg/m\\^2 cisplatin divided into 3 days,which was repeated every 3 weeks for six cycles). All patients will be followed for at least 2 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age more than 18 years;\n2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;\n3. Pathologically confirmed diagnosis of mucosal melanoma;\n4. Completely resected primary tumor (once regional lymph nodes were involved, diagnosed by clinical or imaging examinations, lymphadenectomy was conducted);\n5. No prior systemic adjuvant therapy or regional radiotherapy;\n6. No evidence of distant metastatic disease evaluated by means of lymph nodes ultrasound, endoscopy, and ultrasound of anorectum and genitourinary tract, single-photon emission computed tomography (CT) of bone, and whole-body spiral CT or positron emission tomography-CT (PET-CT);\n7. Normal bone marrow function; and adequate liver and renal function \\[including white blood cell (WBC) count \\> 3,000/mm\\^3;absolute neutrophil count \\> 1,500/mm\\^3; platelets \\>100,000/mm\\^3; serum creatinine less than two times of the upper limit of normal (ULN); bilirubin less than 1.5 times of ULN; aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than 2.5 times of ULN; international normalized ratio less than 1.5 times of ULN; and partial thromboplastin time less than ULN\\].\n\nExclusion Criteria:\n\n1. Cutaneous melanoma or ocular melanoma or melanoma of unknown primary site;\n2. Incomplete resection or primary tumor unable to be resected;\n3. A second cancer diagnosis;\n4. Definite medical history of cirrhoses of the liver or autoimmune diseases;\n5. Severe depression; and pregnant or lactating female.'}, 'identificationModule': {'nctId': 'NCT03435302', 'briefTitle': 'HDI Versus Chemotherapy as Systemic Adjuvant Therapy for Resected Mucosal Melanoma', 'organization': {'class': 'OTHER', 'fullName': 'Peking University Cancer Hospital & Institute'}, 'officialTitle': 'A Multicenter, Randomized, Controlled, Phase III Trial Comparing High-Dose IFN-a2b With Temozolomide Plus Cisplatin as Systemic Adjuvant Therapy for Resected Mucosal Melanoma', 'orgStudyIdInfo': {'id': 'BCHMMAT001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Temozolomide Plus Cisplatin', 'description': 'per os 200 mg/m\\^2/d temozolomide on days 1 to 5 plus i.v. 75 mg/m\\^2 cisplatin divided into 3 days,which was repeated every 3 weeks for six cycles', 'interventionNames': ['Drug: Temozolomide Plus Cisplatin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'High-Dose IFN-a2b', 'description': 'Participants will be treated with i.v. 15×10\\^6U/m\\^2/d IFN-a2b on days 1 to 5 each week for 4 weeks, followed by s.c. 9×10\\^6U IFN- a2b three times per week for 48 weeks.', 'interventionNames': ['Drug: High-Dose IFN-a2b']}], 'interventions': [{'name': 'Temozolomide Plus Cisplatin', 'type': 'DRUG', 'otherNames': ['Temodal.', 'cisplatinum'], 'description': 'Temozolomide is the oral analog of dacarbazine (DTIC), shows potential advantages over dacarbazine.\n\nCisplatin is an agent that can potentially enhance the activity of temozolomide.', 'armGroupLabels': ['Temozolomide Plus Cisplatin']}, {'name': 'High-Dose IFN-a2b', 'type': 'DRUG', 'otherNames': ['Intron'], 'description': 'Interferon belongs to the large class of glycoproteins known as cytokines.', 'armGroupLabels': ['High-Dose IFN-a2b']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100142', 'city': 'Beijing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Bin Lian, MD', 'role': 'CONTACT', 'email': 'lianbin0214@126.com', 'phone': '+86(10)88196951'}, {'name': 'Lu Si, MD', 'role': 'CONTACT', 'email': 'silu.net@hotmail.com', 'phone': '+86(10)88196951'}, {'name': 'Bin Lian, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Beijing Cancer Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Bin Lian, MD', 'role': 'CONTACT', 'email': 'lianbin0214@126.com', 'phone': '+86(10)88196951'}, {'name': 'Lu Si, MD', 'role': 'CONTACT', 'email': 'silu.net@hotmail.com', 'phone': '+86(10)88196951'}], 'overallOfficials': [{'name': 'Jun Guo, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Peking University Cancer Hospital & Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking University Cancer Hospital & Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'Lu Si', 'investigatorAffiliation': 'Peking University Cancer Hospital & Institute'}}}}