Recurrent Nasopharyngeal Carcinoma
Conditions
Keywords
endonasal endoscopic surgery, radiation therapy, nasopharyngeal carcinoma
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.
Interventions
PROCEDUREendonasal endoscopic surgery
143 patients will undergo endonasal endoscopic surgery
RADIATIONradiation therapy(IMRT)
143 patients will undergo radiation therapy.
Sponsors
Chinese Academy of Medical Sciences
Shanghai Municipal Science and Technology Commission
Eye & ENT Hospital of Fudan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 |
| 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 |
| 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 |
| toxicities | From date of randomization until 3 years after randomization,through study completion,up to 3 years. | Using CTCAE Version5.0 to evaluate |
Other
| Measure | Time frame | Description |
|---|---|---|
| quality of life(QoL): EORTC QLQ - H&N35 questionaire | From date of randomization until 3 years after randomization,through study completion,up to 3 years. | using European Organisation for Research and Treatment of Cancer quality of life questionaire（EORTC QLQ）- H&N35，All of the scales and single-item measures range in score from 0 to 100. For all the scales and single-items a high score represents a high level of symptomatology or problems. |
| quality of life(QoL): EORTC QLQ - C30 questionaire | From date of randomization until 3 years after randomization,through study completion,up to 3 years. | using European Organisation for Research and Treatment of Cancer quality of life questionaire（EORTC QLQ) - C30 version3.0. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. |
Countries
China
Contacts
Primary ContactXiaole Song, MD
Backup ContactZhihui Pang
Outcome results
None listed