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

Primary Purpose

Head-and-neck Cancer, Carcinoma of Unknown Primary

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Elective mucosal irradiaton

About this trial

This is an interventional treatment trial for Head-and-neck Cancer

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Shanghai ninth people's hospitalRecruiting
Fudan University Shanghai Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

EMI group

Arm Description

Elective mucosal irradiation

Outcomes

Primary Outcome Measures

Mucosal recurrence free survival

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

Secondary Outcome Measures

Disease-free survival

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

Neck control rate

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

overall survival rate

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

Full Information

NCT ID

NCT02764216

First Posted

May 4, 2016

Last Updated

April 7, 2019

Sponsor

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Collaborators

Shanghai Jiao Tong University School of Medicine

1. Study Identification

Unique Protocol Identification Number

NCT02764216

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2019

Overall Recruitment Status

Unknown status

Study Start Date

January 2010 (Actual)

Primary Completion Date

January 2020 (Anticipated)

Study Completion Date

December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Collaborators

Shanghai Jiao Tong University School of Medicine

4. Oversight

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Head-and-neck Cancer, Carcinoma of Unknown Primary

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

EMI group

Arm Type

Experimental

Arm Description

Elective mucosal irradiation

Intervention Type

Radiation

Intervention Name(s)

Elective mucosal irradiaton

Intervention Description

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

Primary Outcome Measure Information:

Title

Mucosal recurrence free survival

Description

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

Time Frame

3 years

Secondary Outcome Measure Information:

Title

Disease-free survival

Description

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

Title

Neck control rate

Description

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

Time Frame

3 years

Title

overall survival rate

Description

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

Time Frame

3 years

Title

Acute toxicities(gastrointestinal toxicities,hematologic toxicities, dysphagia,oral mucositis)

Description

Acute toxicities(gastrointestinal toxicities,hematologic toxicities, dysphagia,oral mucositis) during the course of radiotherapy

Time Frame

2 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Carcinomas metastatic to cervical lymph node with unknown primary Squamous cell carcinoma, poorly differentiated carcinoma, or undifferentiated carcinoma All patients must be suitable to attend regular follow-up and undergo toxicity assessment. Stage T0, N1-3, M0 disease Karnofsky score over 60 No significant cardiac, chest, gastrointestinal or renal morbidities Exclusion Criteria: Previous radiotherapy to the head and neck region Previous malignancy except non-melanoma skin cancer Previous or concurrent illness which in the investigators opinion would interfere with either completion of therapy or follow-up

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Guopei Zhu, M.D.

antica@gmail.com

Facility Information:

Facility Name

Shanghai ninth people's hospital

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200011

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Guopei Zhu, M.D.

Facility Name

Fudan University Shanghai Cancer Center

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200032

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Guopei Zhu, M.D.

Phone

+8621 6417 5590

antica@gmail.com

First Name & Middle Initial & Last Name & Degree

Guopei Zhu, M.D.

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

31953927

Citation

Dou S, Li R, Zhang L, Wang Z, Xie L, Zhang C, Zhu G. Long-term results of elective mucosal irradiation for head and neck cancer of unknown primary in Chinese population: The EMICUP study. Cancer Med. 2020 Mar;9(5):1712-1720. doi: 10.1002/cam4.2856. Epub 2020 Jan 17.

Results Reference

derived

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

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