Recurrent Nasopharyngeal Cancer: the Effect of Surgery vs IMRT

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Brief Title

Recurrent Nasopharyngeal Cancer: the Effect of Surgery vs IMRT

Official Title

A Multicenter Randomized Controlled Trial for Comparing Endonasal Surgery and Radiation Therapy (IMRT) for Recurrent Nasopharyngeal Carcinoma

Brief Summary

      This study is a multicenter RCT to compare 2-year progression free survival(PFS) rate, PFS,
      overall survival(OS) and life quality of endonasal endoscopic surgery versus IMRT.

Detailed Description

      Local and regional recurrence is a common cause of failure after primary radiotherapy for
      nasopharyngeal carcinoma. Radiotherapy and surgery are the treatments of choice for recurrent
      NPC. This study aims to compare 2 year PFS rate of surgery versus IMRT.A stratified-block
      randomized approach will be used to randomly assign patients into two treatment groups after
      stratification according to T staging (rT1-2 vs rT3-4). 78 patients with rNPC will be
      recruited and randomized into two groups in 1:1 ratio. The primary outcomes will be 2 year
      progression free survival rate(PFS),the secondary outcome measures will be progression free
      survival time(PFS), overall survival(OS) and life quality.Assessment will be performed at
      baseline and 2 years post-randomization.

      subcenters include: Fudan University Shanghai Cancer Center Fujian Medical University Union
      Hospital The First Affiliated Hospital of Nanchang University

      Zhongshan Hospital, Fudan University The People's Hospital of Guangxi Zhuang Autonomous
      Region Fujian Provincial Hospital The Second People's Hospital of Shenzhen

Study Type

Interventional

Primary Outcome

2 year progression free survival(PFS) rate

Secondary Outcome

 progression free survival(PFS)

Condition

Recurrent Nasopharyngeal Carcinoma

Intervention

endonasal endoscopic surgery

Study Arms / Comparison Groups

 endonasal endoscopic surgery group
Description:  39 participants in group 1 will undergo endoscopic surgery

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Procedure

Estimated Enrollment

78

Start Date

April 1, 2020

Completion Date

August 1, 2024

Primary Completion Date

February 1, 2024

Eligibility Criteria

        Inclusion Criteria:

          1. Previous pathological evidence of NPC,including Nonkeratinizing carcinoma,
             keratinizing squamous cell carcinoma and basaloid squamous cell carcinoma;

          2. pathological evidence of rNPC;

          3. Age 18 to 70 years;

          4. History of radical radiotherapy once; Without radiotherapy within 1 year, without
             local treatment for recurrent disease;

          5. Without metastasis;

          6. Expected life span >= 6 months.;

          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. Acceptable organ function.

         11. Acceptable approach of contraception.

        Exclusion Criteria:

          1. Refuse to sign inform consent;

          2. Distant metastases 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. Have a history of a different malignancy(not including basal cell carcinoma);

          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. With serious autoimmune disease.

         12. Participants of other interventional clinical trial.

Gender

All

Ages

18 Years - 70 Years

Accepts Healthy Volunteers

No

Contacts

Hongmeng Yu, +86 15821388769, [email protected]

Administrative Informations

NCT ID

NCT04215510

Organization ID

rNPC RCT of Surgery vs IMRT

Responsible Party

Sponsor

Study Sponsor

Eye & ENT Hospital of Fudan University

Collaborators

 Chinese Academy of Medical Sciences

Study Sponsor

Hongmeng Yu, Study Chair, Eye and ENT Hospital of Fudan University

Verification Date

March 2020