Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2025-12-28 @ 12:11 AM
Study NCT ID:
NCT04528394
Status:
UNKNOWN
Last Update Posted:
2020-08-27
First Post:
2020-08-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Proton Versus Photon Radiotherapy for Nasopharyngeal Carcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000077274', 'term': 'Nasopharyngeal Carcinoma'}], 'ancestors': [{'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009303', 'term': 'Nasopharyngeal Neoplasms'}, {'id': 'D010610', 'term': 'Pharyngeal Neoplasms'}, {'id': 'D010039', 'term': 'Otorhinolaryngologic Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009302', 'term': 'Nasopharyngeal Diseases'}, {'id': 'D010608', 'term': 'Pharyngeal Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017785', 'term': 'Photons'}, {'id': 'D011522', 'term': 'Protons'}], 'ancestors': [{'id': 'D004601', 'term': 'Elementary Particles'}, {'id': 'D055585', 'term': 'Physical Phenomena'}, {'id': 'D008027', 'term': 'Light'}, {'id': 'D060733', 'term': 'Electromagnetic Radiation'}, {'id': 'D055590', 'term': 'Electromagnetic Phenomena'}, {'id': 'D060328', 'term': 'Magnetic Phenomena'}, {'id': 'D055620', 'term': 'Optical Phenomena'}, {'id': 'D011827', 'term': 'Radiation'}, {'id': 'D011840', 'term': 'Radiation, Nonionizing'}, {'id': 'D002414', 'term': 'Cations, Monovalent'}, {'id': 'D002412', 'term': 'Cations'}, {'id': 'D007477', 'term': 'Ions'}, {'id': 'D004573', 'term': 'Electrolytes'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D006859', 'term': 'Hydrogen'}, {'id': 'D004602', 'term': 'Elements'}, {'id': 'D005740', 'term': 'Gases'}, {'id': 'D000071940', 'term': 'Nucleons'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 136}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-04-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2022-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-08-24', 'studyFirstSubmitDate': '2020-08-24', 'studyFirstSubmitQcDate': '2020-08-24', 'lastUpdatePostDateStruct': {'date': '2020-08-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with treatment-related Xerostomia (≥Grade 2) as assessed by NCI CTCAE v4.03', 'timeFrame': 'Xerostomia (≥Grade 2) occurred at 6 months after completion of radiotherapy', 'description': 'CTCAE refers to Common Terminology Criteria for Adverse Events, which is one of the most frequently used criteria for toxicity grading after anti-cancer treatment.'}], 'secondaryOutcomes': [{'measure': 'Overall survival of all patients', 'timeFrame': 'From randomization to death, a median of 3 years.'}, {'measure': 'Progression-free survival of all patients', 'timeFrame': 'From randomization to death or disease progression, a median of 3 years.'}, {'measure': 'Local control', 'timeFrame': 'From randomization to local failure, a median of 3 years.'}, {'measure': 'Regional control', 'timeFrame': 'From randomization to regional failure, a median of 3 years.'}, {'measure': 'Distant control', 'timeFrame': 'From randomization to distant failure, a median of 3 year.'}, {'measure': 'Treatment-related adverse events as assessed by NCI CTCAE v4.03', 'timeFrame': 'Time interval from start to 3 months after completion of radiotherapy.', 'description': 'Acute and late toxicities induced by radiation therapy other than xerostomia.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Nasopharyngeal carcinoma', 'Intensity-modulated radiation therapy', 'Proton beam therapy', 'Carbon-ion radiotherapy', 'Toxicity', 'Survival', 'Disease control'], 'conditions': ['Nasopharyngeal Carcinoma']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the toxicity and therapeutic efficacy of proton or photon combined with carbon ion radiotherapy for newly diagnosed nasopharyngeal carcinoma.Participants will be randomized to 2 arms. Arm 1, participants received photon combined with carbon ion radiotherapy group, Arm 2, participants received proton combined with carbon ion radiotherapy.', 'detailedDescription': 'The purpose of this study is to compare the toxicity and therapeutic efficacy of photon or proton combined with carbon ion radiotherapy for newly diagnosed nasopharyngeal carcinoma.Participants will be randomized to 2 arms. Arm 1 participants received photon combined with carbon ion radiotherapy (photon: 56 Gy/28 Fx, plus carbon: 15-17.5 gray equivalent \\[GyE\\]/5 Fx for boost). Arm 2, participants received proton combined with carbon ion radiotherapy (proton: 56 GyE/28 Fx, plus carbon: 15-17.5 GyE/5 Fx for boost). Adverse events will be documented according to CTCAE v4.03.The response of treatment will be evaluated according to RECIST criteria.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pathologically confirmed Nasopharyngeal carcinoma(WHO II/III type).\n* Age ≥ 18 and ≤ 70 years of age.\n* Eastern Cooperative Oncology Group score: 0-1.\n* Adequate laboratory values within 30 dyas of enrollment to study defined as follows: 1) neutrophil \\> 2000/mm\\^3; 2) platelet \\> 100,000/mm\\^3; 3) total bilirubin \\< 1.5mg/dl; 4) alanine aminotransferase/aspartate aminotransferase \\< 1.5 upper limit of normal; 5) SCr \\< 1.5mg/dl; creatinine clearance rate \\> 60ml/min.\n* Willing to accept adequate contraception for women with childbearing potential.\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* Received radiotherapy for head and neck before.\n* Received surgery(except for biopsy) for primary lesion or cervical lymph node.\n* Previous history of malignant tumor (within 5 years) or simultaneous existence of multiple primary tumors.\n* Presence of diseases (such as Sjögren syndrome) that may interfere evaluation of xerostomia.\n* Accompanied with severe major organ dysfunction.\n* Presence of mental disease that may influence the understanding of informed consent.'}, 'identificationModule': {'nctId': 'NCT04528394', 'briefTitle': 'Proton Versus Photon Radiotherapy for Nasopharyngeal Carcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Proton and Heavy Ion Center'}, 'officialTitle': 'A Randomized Phase II Trial Evaluating Toxicity and Efficacy Between Proton and Photon for Nasopharyngeal Carcinoma', 'orgStudyIdInfo': {'id': 'SPHIC-TR-HNCNS-2019-32'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Photon combined with Carbon ion', 'description': 'The participants received photon: 56 Gy/28 Fx for high-risk area(CTVhigh), 50.4 Gy/28 Fx for lower neck low-risk area(CTVlow), plus carbon ion: 15-17.5 GyE/5 Fx for boost for visible tumors.', 'interventionNames': ['Radiation: Photon', 'Radiation: Carbon ion']}, {'type': 'EXPERIMENTAL', 'label': 'Proton combined with Carbon ion', 'description': 'The participants received proton: 56 GyE/28 Fx for high-risk area(CTVhigh), 50.4 GyE/28 Fx for lower neck low-risk area(CTVlow), plus carbon ion: 15-17.5 GyE/5 Fx for boost for visible tumors.', 'interventionNames': ['Radiation: Proton', 'Radiation: Carbon ion']}], 'interventions': [{'name': 'Photon', 'type': 'RADIATION', 'description': 'Photon combined with Carbon ion in Arm 1', 'armGroupLabels': ['Photon combined with Carbon ion']}, {'name': 'Proton', 'type': 'RADIATION', 'description': 'Proton combined with Carbon ion in Arm 2', 'armGroupLabels': ['Proton combined with Carbon ion']}, {'name': 'Carbon ion', 'type': 'RADIATION', 'description': 'Same dose and fractionation will be used in both arms.', 'armGroupLabels': ['Photon combined with Carbon ion', 'Proton combined with Carbon ion']}]}, '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', 'phone': '133XXX'}, {'name': 'Jiyi Hu, MD', 'role': 'CONTACT', 'email': 'jiyi.hu@sphic.org.cn', 'phone': '1333XXX'}], 'overallOfficials': [{'name': 'Jiade Lu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shanghai Proton and Heavy Ion Center,Shanghai, SPHIC'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'Within 5 years after the publication of the study', 'ipdSharing': 'YES', 'description': 'Individual participant data including baseline characteristics, treatment information and follow-up data on toxicity, survival and disease control will be shared.', 'accessCriteria': 'Data may be shared with radiation oncologists who are interested in examining the efficacy and toxicity of nasopharyngeal carcinoma patients treated with particle beam radiotherapy. Pooled analysis comparing IMRT and particle beam radiotherapy will be of particular interest. Detailed study protocol should be emailed along with the request of the data. We may carefully review the study protocol, and data will only be shared with well-designed studies.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Proton and Heavy Ion Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Executive Vice-President', 'investigatorFullName': 'Jiade J. Lu', 'investigatorAffiliation': 'Shanghai Proton and Heavy Ion Center'}}}}