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

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University48 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Head-and-neck Cancer Carcinoma of Unknown Primary

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (2)

Shanghai ninth people's hospital

Shanghai, Shanghai Municipality, China

RECRUITING

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

RECRUITING

Outcomes

Primary Outcomes

Mucosal recurrence free survival

from date of enrollment to date of first documented primary site emergence or death, assessed up to 3 years.

Time frame: 3 years

Secondary Outcomes

Disease-free survival

from date of enrollment until date of first documented disease progression or death from any cause, assessed up to 3 years.

Time frame: 3 years

Neck control rate

from date of enrollment until date of first documented neck relapse, assessed up to 3 years.

Time frame: 3 years

overall survival rate

from date of enrollment until date of first death from any cause, assessed up to 3 years.

Time frame: 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

Time frame: 2 months

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

Overview

Conditions

Interventions

Eligibility

Locations (2)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts