Elective Mucosal Irradiation in Head-and-Neck Cancer of Unknown Primary

Study Overview
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Brief Summary
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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.

Official Title
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Elective Mucosal Irradiation in Head-and Neck Cancer of Unknown Primary, A Single Arm Phase II Trial

Conditions
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Head-and-neck Cancer, Carcinoma of Unknown Primary

Intervention / Treatment
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* Radiation: Elective mucosal irradiaton


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Carcinomas metastatic to cervical lymph node with unknown primary Squamous cell carcinoma, poorly differentiated carcinoma, or undifferentiated carcinoma All patients must be suitable to attend regular follow-up and undergo toxicity assessment. Stage T0, N1-3, M0 disease Karnofsky score over 60 No significant cardiac, chest, gastrointestinal or renal morbidities Exclusion Criteria: Previous radiotherapy to the head and neck region Previous malignancy except non-melanoma skin cancer Previous or concurrent illness which in the investigators opinion would interfere with either completion of therapy or follow-up

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EMI group<br>Elective mucosal irradiation | Radiation: Elective mucosal irradiaton<br>* Patients will elective mucosal irradiaton based on nodal station, EBV/HPV status, RPN status etc. IMRT will be adopted.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 |