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

• Sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02764216
• Collaborator: Shanghai Jiao Tong University School of Medicine (Other)
• Enrollment: 48
• Locations: 2
• Arm: 1
• Anticipated Duration (Months): 131
• Patients Per Site: 24
• Patients Per Site Per Month: 0.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Head-and-neck Cancer; Carcinoma of Unknown Primary	Radiation: Elective mucosal irradiaton	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 48 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Elective Mucosal Irradiation in Head-and Neck Cancer of Unknown Primary, A Single Arm Phase II Trial
• Actual Study Start Date: Jan 1, 2010
• Anticipated Primary Completion Date: Jan 1, 2020
• Anticipated Study Completion Date: Dec 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: EMI group Elective mucosal irradiation	Radiation: Elective mucosal irradiaton; Patients will elective mucosal irradiaton based on nodal station, EBV/HPV status, RPN status etc. IMRT will be adopted.

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.

2. Neck control rate [3 years]

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

3. overall survival rate [3 years]

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

4. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Shanghai ninth people's hospital	Shanghai	Shanghai	China	200011
2	Fudan University Shanghai Cancer Center	Shanghai	Shanghai	China	200032

Sponsors and Collaborators

• Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
• Shanghai Jiao Tong University School of Medicine

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Guopei Zhu, M.D., Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
• ClinicalTrials.gov Identifier: NCT02764216
• Other Study ID Numbers: 1501160-4
• First Posted: May 6, 2016
• Last Update Posted: Apr 9, 2019
• Last Verified: Apr 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Additional relevant MeSH terms: Head and Neck Neoplasms

Study Results

No Results Posted as of Apr 9, 2019