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| Name | Class |
|---|---|
| Chinese Academy of Medical Sciences | OTHER |
| Shanghai Municipal Science and Technology Commission | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| endonasal endoscopic surgery group | Experimental | 143 participants in group 1 will undergo endoscopic surgery |
|
| radiation therapy group | Active Comparator | 143 participants in group 2 will undergo radiation therapy(IMRT) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| endonasal endoscopic surgery | Procedure | 143 patients will undergo endonasal endoscopic surgery |
|
| 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. |
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| quality of life(QoL): EORTC QLQ - H&N35 questionaire | 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. | From date of randomization until 3 years after randomization,through study completion,up to 3 years. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaole Song, MD | Contact | +86 15821388769 | jxfxsxl@163.com | |
| Zhihui Pang | Contact | +86 18818211894 | pangzhihui1229@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Hongmeng Yu, MD | Eye&ENT Hospital,Fudan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fujian Medical University Union Hospital | Fuzhou | Fujian | China |
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| ID | Term |
|---|---|
| D000077274 | Nasopharyngeal Carcinoma |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| radiation therapy(IMRT) | Radiation | 143 patients will undergo radiation therapy. |
|
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. |
| quality of life(QoL): EORTC QLQ - C30 questionaire | 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. | From date of randomization until 3 years after randomization,through study completion,up to 3 years. |
| The First Affiliated Hospital of Nanchang University | Nanchang | Jiangxi | China |
|
| Fudan University Shanghai cancer center | Shanghai | Shanghai Municipality | 200000 | China |
|
| D009303 |
| Nasopharyngeal Neoplasms |
| D010610 | Pharyngeal Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D009302 | Nasopharyngeal Diseases |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D010038 | Otorhinolaryngologic Diseases |