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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2020-12-31

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.

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Detailed Description

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Conditions

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Head-and-neck Cancer Carcinoma of Unknown Primary

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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EMI group

Elective mucosal irradiation

Group Type EXPERIMENTAL

Elective mucosal irradiaton

Intervention Type RADIATION

Patients will elective mucosal irradiaton based on nodal station, EBV/HPV status, RPN status etc. IMRT will be adopted.

Interventions

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Elective mucosal irradiaton

Patients will elective mucosal irradiaton based on nodal station, EBV/HPV status, RPN status etc. IMRT will be adopted.

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

1. Carcinomas metastatic to cervical lymph node with unknown primary
2. Squamous cell carcinoma, poorly differentiated carcinoma, or undifferentiated carcinoma
3. All patients must be suitable to attend regular follow-up and undergo toxicity assessment.
4. Stage T0, N1-3, M0 disease
5. Karnofsky score over 60
6. No significant cardiac, chest, gastrointestinal or renal morbidities

Exclusion Criteria

1. Previous radiotherapy to the head and neck region
2. Previous malignancy except non-melanoma skin cancer
3. Previous or concurrent illness which in the investigators opinion would interfere with either completion of therapy or follow-up

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No