Early Recurrent Nasopharyngeal Cancer: the Effect of Surgery vs IMRT

Study Overview
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Brief Summary
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This study is a multicenter RCT to compare 3-year overall survival(OS) rate, progression free survival(PFS),local progression free survival(LPFS),regional progression free survival(RPFS),distant metastasis free survival(DMFS), and toxicities of endonasal endoscopic surgery versus IMRT.

Detailed Description
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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 3 year overall survival(OS) 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 N staging (N0 vs non-N0). Patients with rNPC will be recruited and randomized into two groups in 1:1 ratio. The primary outcomes will be 3 year overall survival(OS), the secondary outcome measures will be PFS,LPFS,RPFS,DMFS,and toxicities.Assessment will be performed at baseline and during 3 years post-randomization.

Official Title
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A Multicenter Randomized Controlled Trial for Comparing Endonasal Surgery and Radiation Therapy (IMRT) for T1-T2 Recurrent Nasopharyngeal Carcinoma

Conditions
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Recurrent Nasopharyngeal Carcinoma

Intervention / Treatment
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* Procedure: endonasal endoscopic surgery
* Radiation: radiation therapy(IMRT)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed of recurrent nasopharyngeal carcinoma by pathology or imaging study; Stage T1 or T2 according to AJCC 8th edition ; Aged 18 to 70 years; Without metastasis; previously received 1 course of radiotherapy; Without radiotherapy within 1 year, without local treatment for recurrent disease; Surgical resectable and IMRT suitable; If regional recurrence presented, regional lesion can be treated with local treatments. ECOG score 0 or 1; Sufficient organ function; Acceptable approach of contraception. Exclusion Criteria: Refuse to sign inform consent; Radiation encephalopathy or leptomeningeal disease (LMD); History of radioactive particle planting; Have uncontrolled intercurrent illnesses which will interfere with the ability to undergo therapy; With prior malignancy (excluding adequately treated basal cell or squamous cell skin cancer, in-situ cervical cancer ); Any contradiction to surgery; Have any co-existing condition that would preclude full compliance or safety with the study; Presence of a significant neurological or psychiatric disease, including dementia and seizures; Uncontrolled infectious diseases; Female patients who are at pregnancy or lactation. Without personal freedom or independent civil capacity. With serious autoimmune disease. Participants of other interventional clinical trial.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: endonasal endoscopic surgery group<br>143 participants in group 1 will undergo endoscopic surgery | Procedure: endonasal endoscopic surgery<br>* 143 patients will undergo endonasal endoscopic surgery<br>|
| Active Comparator: radiation therapy group<br>143 participants in group 2 will undergo radiation therapy(IMRT) | Radiation: radiation therapy(IMRT)<br>* 143 patients will undergo radiation therapy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 3 year Overall Survival (OS) rate | The proportion of patients who survived 3 years | From date of randomization until the date of death from any cause,through study completion,up to 3 years. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progression free survival(PFS) | the time from randomization to the first recording of disease progression or death from any cause. | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first，through study completion,up to 3 years. | 
| Local progression free survival(LPFS) | the time from randomization to local failure or death | From randomization to local failure or date of death from any cause,through study completion,up to 3 years. | 
| Regional progression free survival(RPFS) | From randomization to regional failure or death | From randomization to regional failure or date of death from any cause, through study completion,up to 3 years. | 
| Distant metastasis free survival(DMFS) | From randomization to distant metastasis or death | From randomization to distant metastasis or date of death from any cause, through study completion,up to 3 years. | 
| toxicities | Using CTCAE Version5.0 to evaluate | From date of randomization until 3 years after randomization,through study completion,up to 3 years. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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endonasal endoscopic surgery, radiation therapy, nasopharyngeal carcinoma