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| Name | Class |
|---|---|
| Chinese Academy of Medical Sciences | OTHER |
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Sinonasal mucosal melanoma (SNMM) is a very rare tumor, and SNMM is highly aggressive in nature, with a 5-year survival rate of about 20~30%. Most patients underwent local recurrence and distant metastasis within one or two years of treatment.
There is no unified standard for the treatment of SNMM.The principle of treatment for surgically resectable stage T3 and partial T4 SNMM is complete resection of the primary tumor, combined with postoperative radiotherapy. While locally unresectable SNMM has a poorer prognosis, lower incidence, fewer clinical data have been reported.
This study will explore the role of preoperative radiotherapy and chemotherapy in improving the 2-year OS rate, loco-regional control rate and distant metastasis rate.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Preoperative radiotherapy and chemotherapy | Experimental | Preoperative radiotherapy and chemotherapy plus endoscopic surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| endoscopic surgery | Procedure | endoscopic surgery or endoscope-assisted surgery open surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | 2 year Overall Survival rate | From date of first treatment until the date of death from any cause,through study completion,up to 2 years. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival | the date of first treatment to the first recording of disease progression or death from any cause. | From date of first treatment until the date of first documented progression or date of death from any cause, whichever came first，through study completion,up to2 years |
| Local progression free survival |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaole Song, MD | Contact | 15821388769 | jxfxsxl@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Hongmeng Yu, MD,PhD | Eye& ENT Hospital of Fudan University, Shanghai, China | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eye& ENT Hospital, Fudan University | Recruiting | Shanghai | Shanghai Municipality | 200031 | China |
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| intensity-modulated radiation therapy or volume of rotating intensity-modulated radiotherapy or Proton or heavy ion radiation therapy | Radiation | radiotherapy was administrated before surgery |
|
| Chemotherapy drug | Drug | Chemotherapy was administrated before surgery. Chemotherapy may also be administrated after surgery in selected cases. |
|
the date of first treatment to local failure or death |
| From date of first treatment to local failure or date of death from any cause,through study completion,up to 2 years |
| Regional progression free survival | the date of first treatment to regional failure or death | From date of first treatment to regional failure or date of death from any cause, through study completion,up to 2 years |
| Distant metastasis free survival | the date of first treatment to distant metastasis or death | From date of first treatment to distant metastasis or date of death from any cause, through study completion,up to 2 years |
| ORR | objective remission rate | From date of first treatment to the date of best overall response before surgery, assessed up to 6 months |
| ID | Term |
|---|---|
| D004724 | Endoscopy |
| D050397 | Radiotherapy, Intensity-Modulated |
| D011522 | Protons |
| D063193 | Heavy Ion Radiotherapy |
| ID | Term |
|---|---|
| D003949 | Diagnostic Techniques, Surgical |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D019060 | Minimally Invasive Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D020266 | Radiotherapy, Conformal |
| D011881 | Radiotherapy, Computer-Assisted |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D002414 | Cations, Monovalent |
| D002412 | Cations |
| D007477 | Ions |
| D004573 | Electrolytes |
| D007287 | Inorganic Chemicals |
| D006859 | Hydrogen |
| D004602 | Elements |
| D005740 | Gases |
| D000071940 | Nucleons |
| D004601 | Elementary Particles |
| D055585 | Physical Phenomena |
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