Clinical trial NCT04215510: Early 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 T1-T2 Recurrent Nasopharyngeal Carcinoma
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Recurrent Nasopharyngeal Carcinoma
Keywords: endonasal endoscopic surgery
radiation therapy
nasopharyngeal carcinoma
Lead sponsor: Eye & ENT Hospital of Fudan University
Sponsor class: OTHER
Collaborators: name: Chinese Academy of Medical Sciences
name: Shanghai Municipal Science and Technology Commission
First posted: 2020-01-02
Enrollment: 286
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 3 year Overall Survival (OS) rate
timeFrame: From date of randomization until the date of death from any cause,through study completion,up to 3 years.
Secondary outcomes:
measure: progression free survival(PFS)
timeFrame: 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.
measure: Local progression free survival(LPFS)
timeFrame: From randomization to local failure or date of death from any cause,through study completion,up to 3 years.
measure: Regional progression free survival(RPFS)
timeFrame: From randomization to regional failure or date of death from any cause, through study completion,up to 3 years.
measure: Distant metastasis free survival(DMFS)
timeFrame: From randomization to distant metastasis or date of death from any cause, through study completion,up to 3 years.
measure: toxicities
timeFrame: From date of randomization until 3 years after randomization,through study completion,up to 3 years.
Other outcomes:
measure: quality of life(QoL): EORTC QLQ - H&N35 questionaire
timeFrame: From date of randomization until 3 years after randomization,through study completion,up to 3 years.
measure: quality of life(QoL): EORTC QLQ - C30 questionaire
timeFrame: From date of randomization until 3 years after randomization,through study completion,up to 3 years.
Locations:
city: Fuzhou
country: China
facility: Fujian Medical University Union Hospital
state: Fujian
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University
state: Jiangxi
city: Shanghai
country: China
facility: Fudan University Shanghai cancer center
state: Shanghai
Study officials:
affiliation: Eye&ENT Hospital,Fudan University
name: Hongmeng Yu, MD
role: PRINCIPAL_INVESTIGATOR
References: