Ignite Creation Date:
2025-12-25 @ 2:51 AM
Ignite Modification Date:
2026-01-01 @ 2:24 AM
Study NCT ID:
NCT06516133
Status:
RECRUITING
Last Update Posted:
2024-07-23
First Post:
2023-12-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Online Adaptive 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': 'D050397', 'term': 'Radiotherapy, Intensity-Modulated'}, {'id': 'D004358', 'term': 'Drug Therapy'}], 'ancestors': [{'id': 'D020266', 'term': 'Radiotherapy, Conformal'}, {'id': 'D011881', 'term': 'Radiotherapy, Computer-Assisted'}, {'id': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 494}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-05-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2030-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-17', 'studyFirstSubmitDate': '2023-12-27', 'studyFirstSubmitQcDate': '2024-07-17', 'lastUpdatePostDateStruct': {'date': '2024-07-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Locoregional recurrence-free survival', 'timeFrame': '3-year', 'description': 'locoregional progression free survival'}], 'secondaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': '3-year', 'description': 'overall survival'}, {'measure': 'Distant metastasis free survival', 'timeFrame': '3-year', 'description': 'Distant metastasis free survival'}, {'measure': 'Rate of acute radiation-induced events according to Common Terminology Criteria for Adverse Events (CTCAE 5.0)', 'timeFrame': '3 months', 'description': 'Acute radiation-induced events. The minimum and maximum values are 0 and 5 respectively. The higher scores mean a worse outcome.'}, {'measure': 'Rate of late radiation-induced events according to Common Terminology Criteria for Adverse Events (CTCAE 5.0).', 'timeFrame': '3-year', 'description': 'Late radiation-induced events. The minimum and maximum values are 0 and 5 respectively. The higher scores mean a worse outcome.'}, {'measure': 'European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Head and Neck 35 Version 1.0 (EORTC QLQ-HN35 V1.0)', 'timeFrame': 'From baseline to 3 years post-radiotherapy', 'description': 'The minimum and maximum values are 0 and 4 respectively. The higher scores mean a worse outcome.'}, {'measure': 'and National Cancer Institute Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events Version 1.0 (NCI-PRO-CTCAE V1.0.)', 'timeFrame': 'From baseline to 3 years post-radiotherapy', 'description': 'The minimum and maximum values are 0 and 5 respectively. The higher scores mean a worse outcome.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Nasopharyngeal Carcinoma', 'Online adaptive radiotherapy', 'Smaller PTV margin'], 'conditions': ['Nasopharyngeal Carcinoma']}, 'descriptionModule': {'briefSummary': 'In this multicenter, prospective, randomized, controlled, non-inferiority Phase III clinical trial, treatment-naïve patients with nasopharyngeal carcinoma (NPC) without metastasis will be enrolled for curative radiotherapy. The participants will be randomly assigned to two groups. The experimental group will receive online adaptive radiotherapy (ART) during the radiotherapy process, with a smaller PTV margin, while the control group will use original treatment plan during full-course radiotherapy, with a PTV margin of 3 mm. The study aims to compare the survival, adverse events, and quality of survival between the two groups, with the primary endpoint being the locoregional recurrence-free survival rate. The main objective is to determine the role of online ART in nasopharyngeal carcinoma, elucidating its potential to alleviate radiation toxicity in patients while ensuring treatment efficacy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Newly diagnosed nasopharyngeal carcinoma confirmed by pathology, with a histological classification of non-keratinizing carcinoma (according to the World Health Organization, WHO), pathological classification.\n2. No evidence of distant metastasis (M0).\n3. Age between 18 and 70 years.\n4. Eastern Cooperative Oncology Group (ECOG) performance status score:0-1.\n5. Undergoing radical intensity-modulated radiation therapy (IMRT).\n6. No claustrophobia and able to remain in a fixed position for at least 30 minutes\n7. Patients must be informed of the main content of this study, sign an informed consent form, and be willing and able to comply with the treatment, follow-up plan, laboratory tests, and other requirements specified in the study protocol.\n\nExclusion Criteria:\n\n1. Histological types include squamous cell carcinoma or basal cell carcinoma.\n2. Radiation therapy intended for palliative care.\n3. History of malignant tumors, excluding adequately treated basal cell carcinoma, squamous cell carcinoma, and cervical intraepithelial neoplasia.\n4. Pregnant or lactating women (women of childbearing age should undergo pregnancy testing; effective contraception should be emphasized during treatment.\n5. Previous radical radiotherapy for nasopharyngeal cancer.\n6. Primary and neck metastatic lesions treated with chemotherapy or surgery.\n7. Presence of other serious underlying diseases that may pose a greater risk or affect compliance with the trial. Examples include unstable cardiac diseases requiring treatment, renal diseases, chronic hepatitis, poorly controlled diabetes (fasting blood glucose \\> 1.5×ULN), and psychiatric disorders.\n8. Initial assessment of treatment efficacy more than 120 days after the end of radiotherapy.\n9. Inability to undergo enhanced magnetic resonance imaging due to contrast agent allergies, claustrophobia.'}, 'identificationModule': {'nctId': 'NCT06516133', 'acronym': 'OART', 'briefTitle': 'Online Adaptive Radiotherapy for Nasopharyngeal Carcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-sen University'}, 'officialTitle': 'Artificial Intelligence Empowered Online Adaptive Radiotherapy Versus Conventional Radiotherapy in Non-metastatic Nasopharyngeal Carcinoma: an Open-label, Non-inferiority, Multicentre, Randomised Phase 3 Trial', 'orgStudyIdInfo': {'id': 'SL-B2023-685-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional radiotherapy with conventional margins w or w/o chemotherapy', 'description': 'Complete the full course of radiotherapy using the original treatment plan. PTV margin: 3mm.', 'interventionNames': ['Radiation: Intensity modulated radiation therapy (IMRT) with conventional planning target volume (PTV) margin and without online adaptive radiotherapy', 'Drug: Chemotherapy']}, {'type': 'EXPERIMENTAL', 'label': 'Radiotherapy with smaller margin and online adaptive radiotherapy w or w/o chemotherapy', 'description': 'Throughout the course of radiotherapy, the treatment plan is adjusted online based on the anatomical and dosimetric changes in the target volumes and organs at risk of the patients.\n\nPTV margin: smaller.', 'interventionNames': ['Radiation: Intensity modulated radiation therapy (IMRT) with smaller planning target volume (PTV) margin and online adaptive radiotherapy', 'Drug: Chemotherapy']}], 'interventions': [{'name': 'Intensity modulated radiation therapy (IMRT) with conventional planning target volume (PTV) margin and without online adaptive radiotherapy', 'type': 'RADIATION', 'description': 'Radiation: Complete the full course of radiotherapy using the original treatment plan.\n\nPlanning target volume (PTV) margin: 3mm;', 'armGroupLabels': ['Conventional radiotherapy with conventional margins w or w/o chemotherapy']}, {'name': 'Chemotherapy', 'type': 'DRUG', 'description': 'Chemotherapy: If given, platinum-based.', 'armGroupLabels': ['Conventional radiotherapy with conventional margins w or w/o chemotherapy']}, {'name': 'Intensity modulated radiation therapy (IMRT) with smaller planning target volume (PTV) margin and online adaptive radiotherapy', 'type': 'RADIATION', 'description': 'Radiation: During the course of radiotherapy, the treatment plan is adjusted online based on the anatomical and dosimetric changes in the target volumes and organs at risk of patients.\n\nplanning target volume (PTV) margin: smaller.', 'armGroupLabels': ['Radiotherapy with smaller margin and online adaptive radiotherapy w or w/o chemotherapy']}, {'name': 'Chemotherapy', 'type': 'DRUG', 'description': 'Chemotherapy: If given, platinum-based', 'armGroupLabels': ['Radiotherapy with smaller margin and online adaptive radiotherapy w or w/o chemotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510060', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yu-xian Yang', 'role': 'CONTACT', 'email': 'yangyx1@sysucc.org.cn', 'phone': '+86 147 4892 2370'}, {'name': 'Guan-quan Zhou', 'role': 'CONTACT', 'email': 'zhougq@sysucc.org.cn', 'phone': '+86 159 1437 2887'}, {'name': 'Ying Sun, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Sun Yat-sen University Cancer Center', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Yu-xian Yang, MD', 'role': 'CONTACT', 'email': 'yangyx1@sysucc.org.cn', 'phone': '+86 147 4892 2370'}, {'name': 'Guan-qun Zhou, PhD', 'role': 'CONTACT', 'email': 'zhougq@sysucc.org.cn', 'phone': '+86 159 1437 2887'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Yat-sen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'YingSun', 'investigatorAffiliation': 'Sun Yat-sen University'}}}}