Early Recurrent Nasopharyngeal Cancer: the Effect of Surgery vs IMRT

Phase 3

Not yet recruiting

• Conditions: Recurrent Nasopharyngeal Carcinoma
• Interventions: Procedure: endonasal endoscopic surgery; Radiation: radiation therapy(IMRT)

• Registration Number: NCT04215510
• Lead Sponsor: Eye & ENT Hospital of Fudan University

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2019-12-02
• Study First Submitted QC: 2019-12-31
• Study First Posted: 2020-01-02
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-20
• Last Update Posted: 2021-02-23
• Study Start: 2021-03-01
• Primary Completion: 2027-03-01
• Study Completion: 2027-03-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 286

Inclusion Criteria

1. Diagnosed of recurrent nasopharyngeal carcinoma by pathology or imaging study;
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

1. Refuse to sign inform consent;
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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
endonasal endoscopic surgery group	endonasal endoscopic surgery	143 participants in group 1 will undergo endoscopic surgery
radiation therapy group	radiation therapy(IMRT)	143 participants in group 2 will undergo radiation therapy(IMRT)

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (3)

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, China