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

Phase 2

• Conditions: Carcinoma of Unknown Primary; Head-and-neck Cancer
• Interventions: Radiation: Elective mucosal irradiaton

• Registration Number: NCT02764216
• Lead Sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2016-05-04
• Study First Submitted QC: 2016-05-05
• Study First Posted: 2016-05-06
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-07
• Last Update Posted: 2019-04-09
• Primary Completion: 2020-01
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 48

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
EMI group	Elective mucosal irradiaton	Elective mucosal irradiation

Primary Outcome Measures

Name	Time	Method
Mucosal recurrence free survival	3 years	from date of enrollment to date of first documented primary site emergence or death, assessed up to 3 years.

Secondary Outcome Measures

Name	Time	Method
Acute toxicities(gastrointestinal toxicities,hematologic toxicities, dysphagia,oral mucositis)	2 months	Acute toxicities(gastrointestinal toxicities,hematologic toxicities, dysphagia,oral mucositis) during the course of radiotherapy
Neck control rate	3 years	from date of enrollment until date of first documented neck relapse, assessed up to 3 years.
Disease-free survival	3 years	from date of enrollment until date of first documented disease progression or death from any cause, assessed up to 3 years.
overall survival rate	3 years	from date of enrollment until date of first death from any cause, assessed up to 3 years.

Trial Locations

Locations (2)

Shanghai ninth people's hospital; 🇨🇳 Shanghai, Shanghai, China

Fudan University Shanghai Cancer Center; 🇨🇳 Shanghai, Shanghai, China