NCT02764216

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
48

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 2010

Longer than P75 for phase_2

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
6.3 years until next milestone

First Submitted

Initial submission to the registry

May 4, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 6, 2016

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

April 9, 2019

Status Verified

April 1, 2019

Enrollment Period

10 years

First QC Date

May 4, 2016

Last Update Submit

April 7, 2019

Conditions

Head-and-neck CancerCarcinoma of Unknown Primary

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Disease-free survival

    3 years

  • Neck control rate

    3 years

  • overall survival rate

    3 years

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

    2 months

Study Arms (1)

EMI group

EXPERIMENTAL

Elective mucosal irradiation

Radiation: Elective mucosal irradiaton

Interventions

Elective mucosal irradiatonRADIATION

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

EMI group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Shanghai ninth people's hospital

Shanghai, Shanghai Municipality, 200011, China

RECRUITING

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Related Publications (1)

  • 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.

    PMID: 31953927DERIVED

MeSH Terms

Conditions

Head and Neck NeoplasmsNeoplasms, Unknown Primary

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsNeoplasm MetastasisNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Guopei Zhu, M.D.

CONTACT

antica@gmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

May 4, 2016

First Posted

May 6, 2016

Study Start

January 1, 2010

Primary Completion

January 1, 2020

Study Completion

December 1, 2020

Last Updated

April 9, 2019

Record last verified: 2019-04

Locations

CN(2)