Adjuvant Therapy Versus Endoscopic Surgery Alone in Early-stage Recurrent Nasopharyngeal Carcinoma: A Multicenter Randomized Controlled Trial

Status: Recruiting
Location: See all (7) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

Adjuvant Therapy Versus Endoscopic Surgery Alone in Early-stage Recurrent Nasopharyngeal Carcinoma: A Multicenter Randomized Controlled Trial

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• Pathologically diagnosed with recurrent nasopharyngeal carcinoma;

• Stage rT1 or rT2(superficial parapharyngeal space, distance to internal carotid artery \>5mm)or rT3 (confined to the bottom wall of the sphenoid sinus),according to AJCC 8th edition;

• Cervical lymph node metastasis can be controlled locally

• Age 18 to 75 years;

• Without distant metastasis;

• Informed consent forms signed;

• ≥6months from the accomplishment of radiation to recurrence

• previously radiotherapy for only 1 course;

• ECOG score 0-2 and can tolerate chemotherapy and immunotherapy

⁃ Sufficient organ function;

⁃ Undergone endoscopic surgery with negative pathological margin;

Locations
Other Locations
China
Fujian Medical University Union Hospital
NOT_YET_RECRUITING
Fuzhou
The People's Hospital of Guangxi Zhuang Autonomous Region
RECRUITING
Nanning
Changhai Hospital
RECRUITING
Shanghai
Eye& ENT Hospital, Fudan University
RECRUITING
Shanghai
Shanghai Sixth People's Hospital
NOT_YET_RECRUITING
Shanghai
Shanghai Zhongshan Hospital
NOT_YET_RECRUITING
Shanghai
Shenzhen Second People's Hospital
NOT_YET_RECRUITING
Shenzhen
Contact Information
Primary
Xiaole Song, MD
jxfxsxl@163.com
+8621 64377134
Backup
Yuting Lai
Time Frame
Start Date: 2024-06-25
Estimated Completion Date: 2028-06-30
Participants
Target number of participants: 176
Treatments
No_intervention: The control group
Patients in the control group would go through observation and follow-up after recurrent endoscopic surgery.
Experimental: The experimental group
Patients in the experimental group would be implemented with adjuvant therapy including chemotherapy and immunotherapy after endoscopic surgery.
Related Therapeutic Areas
Sponsors
Collaborators: Shanghai 6th People's Hospital, People's Hospital of Guangxi Zhuang Autonomous Region, Shenzhen Second People's Hospital, Fujian Medical University Union Hospital, Shanghai Zhongshan Hospital, Changhai Hospital
Leads: Eye & ENT Hospital of Fudan University

This content was sourced from clinicaltrials.gov

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