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

Carcinoma of Unknown Primary Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02764216
• Other study ID #: 1501160-4
• Status: Recruiting
• Phase: Phase 2
• Start date: January 2010
• Est. completion date: December 2020

Study information

• Verified date: April 2019
• Source: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
• Contact: Guopei Zhu, M.D.
• Email: antica[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: December 2020
• Est. primary completion date: January 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma of Unknown Primary
• Head and Neck Neoplasms
• Head-and-neck Cancer
• Neoplasms, Unknown Primary

Intervention

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

Locations

Country	Name	City	State
China	Fudan University Shanghai Cancer Center	Shanghai	Shanghai
China	Shanghai ninth people's hospital	Shanghai	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University	Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Neck control rate	from date of enrollment until date of first documented neck relapse, assessed up to 3 years.	3 years
Secondary	overall survival rate	from date of enrollment until date of first death from any cause, assessed up to 3 years.	3 years
Secondary	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