Early Recurrent Nasopharyngeal Cancer: the Effect of Surgery vs IMRT
NCT ID: NCT04215510
Last Updated: 2021-02-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE3
286 participants
INTERVENTIONAL
2021-03-01
2027-03-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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endonasal endoscopic surgery group
143 participants in group 1 will undergo endoscopic surgery
endonasal endoscopic surgery
143 patients will undergo endonasal endoscopic surgery
radiation therapy group
143 participants in group 2 will undergo radiation therapy(IMRT)
radiation therapy(IMRT)
143 patients will undergo radiation therapy.
Interventions
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endonasal endoscopic surgery
143 patients will undergo endonasal endoscopic surgery
radiation therapy(IMRT)
143 patients will undergo radiation therapy.
Eligibility Criteria
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Inclusion Criteria
2. Stage T1 or T2 according to AJCC 8th edition ;
3. Aged 18 to 70 years;
4. Without metastasis;
5. previously received 1 course of radiotherapy;
6. Without radiotherapy within 1 year, without local treatment for recurrent disease;
7. Surgical resectable and IMRT suitable;
8. If regional recurrence presented, regional lesion can be treated with local treatments.
9. ECOG score 0 or 1;
10. Sufficient organ function;
11. Acceptable approach of contraception.
Exclusion Criteria
2. Radiation encephalopathy or leptomeningeal disease (LMD);
3. History of radioactive particle planting;
4. Have uncontrolled intercurrent illnesses which will interfere with the ability to undergo therapy;
5. With prior malignancy (excluding adequately treated basal cell or squamous cell skin cancer, in-situ cervical cancer );
6. Any contradiction to surgery;
7. Have any co-existing condition that would preclude full compliance or safety with the study;
8. Presence of a significant neurological or psychiatric disease, including dementia and seizures;
9. Uncontrolled infectious diseases;
10. Female patients who are at pregnancy or lactation.
11. Without personal freedom or independent civil capacity.
12. With serious autoimmune disease.
13. Participants of other interventional clinical trial.
18 Years
70 Years
ALL
No
Sponsors
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Chinese Academy of Medical Sciences
OTHER
Shanghai Municipal Science and Technology Commission
OTHER_GOV
Eye & ENT Hospital of Fudan University
OTHER
Responsible Party
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Hongmeng Yu
MD,PhD
Principal Investigators
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Hongmeng Yu, MD
Role: PRINCIPAL_INVESTIGATOR
Eye&ENT Hospital,Fudan University
Locations
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Fujian Medical University Union Hospital
Fuzhou, Fujian, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
Fudan University Shanghai cancer center
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Desheng Wang, MD
Role: primary
Haichun Lai, MD
Role: backup
Jing Ye, MD
Role: primary
Lin Kong, MD
Role: primary
Jiyi Hu, MD
Role: backup
Other Identifiers
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early-rNPC-RCT-01
Identifier Type: -
Identifier Source: org_study_id
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