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| Name | Class |
|---|---|
| Shanghai Jiao Tong University School of Medicine | OTHER |
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The optimal treatment of HNCUP remains controversial and lacks evidence from prospective randomized trials. The management of these patients relies primarily on surgery and radiotherapy. The role of radiotherapy in sterilizing putative mucosal sites remains controversial. The main debate concerns the extent of the radiation field. Although pan-mucosal irradiation from the nasopharynx to the hypopharynx and bilateral neck nodes reduces the risk of emergence of a mucosal primary or a nodal relapse, it has been associated with significant toxicity and long-term morbidity (mostly xerostomia and dysphagia). Most single institution retrospective studies have not shown any advantage for more extensive irradiation.Therefore, elective mucosal irradiation may might be appropriate only for these patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EMI group | Experimental | Elective mucosal irradiation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Elective mucosal irradiaton | Radiation | Patients will elective mucosal irradiaton based on nodal station, EBV/HPV status, RPN status etc. IMRT will be adopted. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mucosal recurrence free survival | from date of enrollment to date of first documented primary site emergence or death, assessed up to 3 years. | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Disease-free survival | from date of enrollment until date of first documented disease progression or death from any cause, assessed up to 3 years. | 3 years |
| Neck control rate | from date of enrollment until date of first documented neck relapse, assessed up to 3 years. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Guopei Zhu, M.D. | Contact | antica@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai ninth people's hospital | Recruiting | Shanghai | Shanghai Municipality | 200011 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31953927 | Derived | Dou S, Li R, Zhang L, Wang Z, Xie L, Zhang C, Zhu G. Long-term results of elective mucosal irradiation for head and neck cancer of unknown primary in Chinese population: The EMICUP study. Cancer Med. 2020 Mar;9(5):1712-1720. doi: 10.1002/cam4.2856. Epub 2020 Jan 17. |
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D009382 | Neoplasms, Unknown Primary |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D009362 | Neoplasm Metastasis |
| D009385 | Neoplastic Processes |
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| 3 years |
| overall survival rate | from date of enrollment until date of first death from any cause, assessed up to 3 years. | 3 years |
| Acute toxicities(gastrointestinal toxicities,hematologic toxicities, dysphagia,oral mucositis) | Acute toxicities(gastrointestinal toxicities,hematologic toxicities, dysphagia,oral mucositis) during the course of radiotherapy | 2 months |
| Fudan University Shanghai Cancer Center | Recruiting | Shanghai | Shanghai Municipality | 200032 | China |
|
| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |