Ignite Creation Date:
2025-12-25 @ 12:40 AM
Ignite Modification Date:
2026-01-05 @ 6:39 PM
Study NCT ID:
NCT06533267
Status:
RECRUITING
Last Update Posted:
2024-08-01
First Post:
2024-07-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Endoscopic Surgery vs. Intensity Modulated Radiotherapy for Stage I 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'}], 'ancestors': [{'id': 'D020266', 'term': 'Radiotherapy, Conformal'}, {'id': 'D011881', 'term': 'Radiotherapy, Computer-Assisted'}, {'id': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 442}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-03-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2034-03-25', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-29', 'studyFirstSubmitDate': '2024-07-24', 'studyFirstSubmitQcDate': '2024-07-29', 'lastUpdatePostDateStruct': {'date': '2024-08-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2034-03-25', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Survival (OS)', 'timeFrame': '5 years', 'description': 'Defined as the time interval from randomization to death due to any cause.'}, {'measure': 'Incidence of ≥3 grade adverse events', 'timeFrame': '5 years', 'description': 'The proportion of patients with ≥3 grade adverse events according to CTCAE 5.0/RTOG criteria.'}], 'secondaryOutcomes': [{'measure': 'Local Regional Relapse-Free Survival (LRRFS)', 'timeFrame': '5 years', 'description': 'Defined as the time from randomisation to the date of first locoregional relapse.'}, {'measure': 'Distant Metastasis-Free Survival (DMFS)', 'timeFrame': '5 years', 'description': 'Defined as the time interval from randomisation to the date of first distant metastases.'}, {'measure': 'Progress-Free Survival (PFS)', 'timeFrame': '5 years', 'description': 'Defined as time from randomization to locoregional or distant metastasis relapse or death from any cause, whichever occurred first.'}, {'measure': 'The proportion of patients with treatment related complications', 'timeFrame': '5 years', 'description': 'The proportion of patients with treatment related complications according to NCI-CTC5.0 criteria and RTOG criteria.'}, {'measure': 'Objective response rate (ORR)', 'timeFrame': '3 months', 'description': 'Objective response rate (ORR) is defined as the proportion of patients with a complete response or partial response to treatment. (according to tumor imaging examinations 3 months after the end of treatment/supplementary treatment)'}, {'measure': 'Score of survival quality according to the EORTC Quality of Life Questionnaire (QLQ)-C30 (V3.0)', 'timeFrame': '5 years', 'description': 'Score of survival quality according to the EORTC Quality of Life Questionnaire (QLQ)-C30 (V3.0) before treatment, during treatment, after treatment.'}, {'measure': 'Score of survival quality according to the EORTC Quality of Life Questionnaire Head and Neck (The QLQ-H&N35)', 'timeFrame': '5 years', 'description': 'Score of survival quality according to the EORTC Quality of Life Questionnaire Head and Neck (The QLQ-H\\&N35) before treatment, during treatment, after treatment.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Nasopharyngeal Carcinoma', 'Intensity Modulated Radiotherapy', 'Surgery']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to compare the survival and adverse reactions differences between endoscopic surgery and intensity modulated radiotherapy for patients with newly diagnosed stage Ⅰ nasopharyngeal carcinoma, aiming to verifying the efficacy and safety of endoscopic surgery for stage Ⅰ nasopharyngeal carcinoma.', 'detailedDescription': 'The newly diagnosed non-metastatic nasopharyngeal carcinoma has shown satisfactory therapeutic effect under the intensity modulated radiation. The 5-year survival rate of the newly diagnosed Ⅰ nasopharyngeal carcinoma was more than 95%. However, mos patients receiving radical radiotherapy will experience different degrees of acute or chronic radiation injury, which will affect the quality of life of patients to varying degrees. For stage Ⅰ nasopharyngeal carcinoma with primary lesion confined to nasopharyngeal mucosa and without regional lymph node metastasis, in theory, the primary lesion can be removed by minimally invasive surgery without need of preventive treatment of cervical lymph nodes according to the prior study.\n\nBased on our previous research results, we stratified the nasopharyngeal primary tumor diameter of stage Ⅰ nasopharyngeal carcinoma by whether the short diameter of retropharyngeal lymph nodes and neck lymph nodes was smaller than 0.4cm and 0.6cm respectively, and the tumor diameter of nasopharyngeal primary tumor was ≤ 1.5cm. This study evaluated the efficacy and safety of endoscopic minimally invasive surgery compared to conventional intensity-modulated radiotherapy for these stage Ⅰ nasopharyngeal carcinoma.\n\nIn this study, the stage Ⅰ patients in the experimental group only received endoscopic nasopharynx resection and were followed up closely to monitor the recurrence and distant metastasis of the tumor.\n\nThe patients in the control group received conventional intensity-modulated radiotherapy and regular follow-up. The target area and dose of radiotherapy were as follows: GTVnx: primary lesion of the nasopharynx; CTV1: high-risk area and the entire nasopharynx; CTV2: low-risk area. The recommended intensity-modulated radiotherapy dose is GTVnx(69.96 Gy/33 Fr/2.12 Gy); CTV1(60.60 Gy/33 Fr/1.82 Gy); CTV2(54.12 Gy/33 Fr/1.64 Gy).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Karnofsky score \\>70.\n* Non-keratinized carcinoma of the nasopharynx (differentiated or undifferentiated, i.e., WHO type II or III) or carcinoma in situ confirmed histologically and/or cytologically.\n* According to the eighth edition of UICC/AJCC staging, the patient was defined as T1N0M0 stage I.\n* The maximum short diameters of retropharyngeal lymph nodes and cervical lymph nodes were not more than 0.4cm and 0.6cm respectively, or retropharyngeal lymph nodes and cervical lymph nodes were 0.4-0.5cm and 0.6-1.0cm respectively but PET/CT showed negative.\n* Informed Concent signed with willingness to obey the follow-up, treatment, examination and any other programs according to the research protocol.\n\nExclusion Criteria:\n\n* MRI showed that the primary tumor diameter \\>1.5cm, or internal carotid artery vascular malformation which would seriously affect the operation.\n* Diagnosed as recurrent or distant metastatic nasopharyngeal carcinoma or together with any other malignancy.\n* Suffering severe organ dysfunction or physical disorder which could not tolerate operation or radiotherapy.\n* Unable to cooperate with regular follow-up due to psychological, social, domestic or geological reasons.'}, 'identificationModule': {'nctId': 'NCT06533267', 'briefTitle': 'Endoscopic Surgery vs. Intensity Modulated Radiotherapy for Stage I Nasopharyngeal Carcinoma.', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-sen University'}, 'officialTitle': 'Endoscopic Surgery Compared With Intensity Modulated Radiotherapy for Stage I Nasopharyngeal Carcinoma : A Multicenter, Randomized Controlled Clinical Trial.', 'orgStudyIdInfo': {'id': 'SYSUCC-CMY-2024-02-24'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Surgery plus close follow-up', 'description': 'Surgery:\n\nEndoscopic Nasopharyngectomy: Radical resection of the primary lesion using nasal endoscopy.', 'interventionNames': ['Procedure: Endoscopic nasopharyngectomy followed close follow-up']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Intensity modulated radiotherapy', 'description': 'Radiotherapy:\n\nIntensity-modulated Radiotherapy:\n\nGTVnx: 69.96Gy/33Fr/2.12Gy CTV1: 59.4Gy/33Fr/1.8Gy CTV2: 54.12Gy/33Fr/1.64Gy', 'interventionNames': ['Radiation: Intensity-modulated Radiotherapy']}], 'interventions': [{'name': 'Endoscopic nasopharyngectomy followed close follow-up', 'type': 'PROCEDURE', 'description': 'Radical resection of primary lesion using nasal endoscopy.\n\nAfter the treatment, the electronic nasal endoscopy was reviewed every two weeks to determine the healing of the wound, whether there was tumor recurrence, until the surgical wound was completely healed. The patients were followed up at least once every three months from the first year to the third year, at least once every six months from the fourth year to the fifth year, and at least once every year after five years.', 'armGroupLabels': ['Surgery plus close follow-up']}, {'name': 'Intensity-modulated Radiotherapy', 'type': 'RADIATION', 'description': 'GTVnx (nasopharyngeal lesions): 69.96Gy/33Fr/2.12Gy CTV1: 60.60Gy/33Fr/1.82Gy CTV2: 54.12Gy/33Fr/1.64Gy.\n\nAfter treatment, patients were followed up every 3-6 months from the first year to the third year, every 6-12 months from the fourth year to the fifth year, and at least once a year after five years.', 'armGroupLabels': ['Intensity modulated radiotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '519000', 'city': 'Zhuhai', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Youping Liu, MD', 'role': 'CONTACT', 'email': 'liuyp78@email.sysu.edu.cn', 'phone': '+8613751763276'}], 'facility': 'The Fifth Affiliated Hospital of Sun Yat-sen University', 'geoPoint': {'lat': 22.27694, 'lon': 113.56778}}], 'centralContacts': [{'name': 'Ming-Yuan Chen, MD,PhD', 'role': 'CONTACT', 'email': 'chmingy@email.sysu.edu.cn', 'phone': '+8613903052650'}, {'name': 'Youping Liu, PhD', 'role': 'CONTACT', 'email': 'liuyp78@email.sysu.edu.cn', 'phone': '+86137517763276'}], 'overallOfficials': [{'name': 'Ming-Yuan Chen, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sun Yat-sen University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Yat-sen University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fifth Affiliated Hospital, Sun Yat-Sen University', 'class': 'OTHER'}, {'name': 'Fifth Affiliated Hospital of Guangzhou Medical University', 'class': 'OTHER'}, {'name': 'Huazhong University of Science and Technology Union ShenZhen Hospital (Nanshan Hospital)', 'class': 'UNKNOWN'}, {'name': 'First Affiliated Hospital, Sun Yat-Sen University', 'class': 'OTHER'}, {'name': 'Nanfang Hospital, Southern Medical University', 'class': 'OTHER'}, {'name': "First People's Hospital of Foshan", 'class': 'OTHER'}, {'name': "Zhongshan People's Hospital, Guangdong, China", 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professior', 'investigatorFullName': 'Ming-Yuan Chen', 'investigatorAffiliation': 'Sun Yat-sen University'}}}}