Ignite Creation Date:
2025-12-25 @ 1:10 AM
Ignite Modification Date:
2026-02-25 @ 8:17 PM
Study NCT ID:
NCT02942693
Status:
UNKNOWN
Last Update Posted:
2018-09-28
First Post:
2016-10-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trail Evaluating Particle Therapy With or Without Apatinib for H&N Adenoid Cystic Carcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003528', 'term': 'Carcinoma, Adenoid Cystic'}], 'ancestors': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C553458', 'term': 'apatinib'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-09-26', 'studyFirstSubmitDate': '2016-10-18', 'studyFirstSubmitQcDate': '2016-10-20', 'lastUpdatePostDateStruct': {'date': '2018-09-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-10-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Short-term treatment response of all patients', 'timeFrame': 'Three months after completion of particle therapy.'}], 'secondaryOutcomes': [{'measure': 'Number of participants with treatment-related adverse events as assessed by NCI CTCAE v4.03', 'timeFrame': 'Time interval from start to 3 months after completion of particle therapy.'}, {'measure': 'Overall survival of all patients', 'timeFrame': 'From the diagnosis of H&N adenoid cystic carcinoma, a median of 3 years.'}, {'measure': 'Progression-free survival of all patients', 'timeFrame': 'From the completion of the particle therapy, a median of 3 years.'}, {'measure': 'Local progression-free survival of all patients', 'timeFrame': 'From the completion of the particle therapy, a median of 3 years.'}, {'measure': 'Distant metastasis-free survival of all patients', 'timeFrame': 'From the completion of the particle therapy, a median of 3 years.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Apatinib', 'Particle therapy'], 'conditions': ['Adenoid Cystic Carcinoma']}, 'descriptionModule': {'briefSummary': 'It is a randomized phase II study to determine the efficacy and safety of particle therapy with or without apatinib as induction therapy for the treatment of head and neck adenoid cystic carcinoma. Participants will be randomized to arm 1: receiving apatinib for 6 weekly followed by particle radiotherapy; arm 2: particle radiotherapy alone.', 'detailedDescription': 'The purpose of this study is to determine the efficacy and safety of particle therapy with or without apatinib as induction therapy for the treatment of head and neck adenoid cystic carcinoma. It is a randomized phase II clinical trial with single phase and 2 experimental arms. Participants will be randomized to arm 1, receiving apatinib (0.5g, daily) for 6 weekly followed by particle radiotherapy (proton: 56 GyE/28 Fx, plus carbon: 15 GyE/5 Fx for boost); arm 2: particle radiotherapy alone (proton: 56 GyE/28 Fx, plus carbon: 15 GyE/5 Fx for boost). The short term response will be evaluated using RECIST criteria. And the acute and late toxicities will be evaluated according to NCI CTCAE v4.03.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pathologically confirmed ACC\n* Inoperable disease or postoperative residual disease detected by imaging studies\n* Age ≥ 18 and ≤ 65 years of age\n* ECOG \\< 2, no significant active concurrent medical illnesses\n* Adequate laboratory values within 30 dyas of enrollment to study defined as follows: N \\> 2000/mm\\^3; PLT \\> 100,000/mm\\^3; total bilirubin \\< 1.5mg/dl; AST/ALT \\< 1.5 ULN; SCr \\< 1.5mg/dl; CCR \\> 60ml/min\n* Willing to accept adequate contraception for women with childbearing potential\n* Ability to understand character and individual consequences of the clinical trial\n* Willing to sign the written informed consent; Informed consent must be signed before the enrollment in the trial\n\nExclusion Criteria:\n\n* Presence of distant metastasis\n* Pregnant or lactating women\n* A diagnosis of malignancy other than CIS of the cervix, BCC and SCC of the skin within the past 5 years\n* Refusal of the patient to participate into the study'}, 'identificationModule': {'nctId': 'NCT02942693', 'briefTitle': 'Trail Evaluating Particle Therapy With or Without Apatinib for H&N Adenoid Cystic Carcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Proton and Heavy Ion Center'}, 'officialTitle': 'A Phase II Randomized Trial of Efficacy and Safety of Particle Therapy With or Without Apatinib as Induction Therapy for Treatment of Head and Neck Adenoid Cystic Carcinoma', 'orgStudyIdInfo': {'id': 'SPHIC-TR-HNCNS-2016-08'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Apatinib with Particle Therapy', 'description': 'Participants will receive apatinib (0.5g, daily) for 6 weekly followed by particle radiotherapy (proton: 56 GyE/28 Fx, plus carbon: 15 GyE/5 Fx for boost).', 'interventionNames': ['Drug: Apatinib', 'Radiation: Particle Therapy']}, {'type': 'EXPERIMENTAL', 'label': 'Particle Therapy', 'description': 'Participants will receive particle radiotherapy alone (proton: 56 GyE/28 Fx, plus carbon: 15 GyE/5 Fx for boost).', 'interventionNames': ['Radiation: Particle Therapy']}], 'interventions': [{'name': 'Apatinib', 'type': 'DRUG', 'description': 'Apatinib will be used as induction therapy in experimental arm.', 'armGroupLabels': ['Apatinib with Particle Therapy']}, {'name': 'Particle Therapy', 'type': 'RADIATION', 'description': 'Same total dose and fractionation will be used in both arms.', 'armGroupLabels': ['Apatinib with Particle Therapy', 'Particle Therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '201315', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Lin Kong, MD', 'role': 'CONTACT', 'email': 'lin.kong@sphic.org.cn'}, {'name': 'Jiyi Hu, MD', 'role': 'CONTACT', 'email': 'jiyi.hu@sphic.org.cn'}, {'name': 'Jiade J Lu, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Shanghai Proton and Heavy Ion Center', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Lin Kong, MD', 'role': 'CONTACT', 'email': 'lin.kong@sphic.org.cn'}, {'name': 'Jiyi Hu, MD', 'role': 'CONTACT', 'email': 'jiyi.hu@sphic.org.cn'}], 'overallOfficials': [{'name': 'Jiade J Lu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shanghai Proton and Heavy Ion Center,Shanghai, SPHIC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Proton and Heavy Ion Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Executive Vice President of Shanghai Proton and Heavy Ion Center', 'investigatorFullName': 'Jiade J. Lu', 'investigatorAffiliation': 'Shanghai Proton and Heavy Ion Center'}}}}