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

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ClinicalTrials.gov Identifier: NCT02764216
Recruitment Status : Recruiting
First Posted : May 6, 2016
Last Update Posted : April 9, 2019
Sponsor:
Collaborator:
Shanghai Jiao Tong University School of Medicine
Information provided by (Responsible Party):
Guopei Zhu, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Tracking Information
First Submitted Date  ICMJE May 4, 2016
First Posted Date  ICMJE May 6, 2016
Last Update Posted Date April 9, 2019
Actual Study Start Date  ICMJE January 2010
Estimated Primary Completion Date January 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 7, 2019)
Mucosal recurrence free survival [ Time Frame: 3 years ]
from date of enrollment to date of first documented primary site emergence or death, assessed up to 3 years.
Original Primary Outcome Measures  ICMJE
 (submitted: May 5, 2016)
Mucosal control rate [ Time Frame: 2 years ]
from date of enrollment to date of first documented primary site emergence, assessed up to 2 years.
Change History Complete list of historical versions of study NCT02764216 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 7, 2019)
  • Disease-free survival [ Time Frame: 3 years ]
    from date of enrollment until date of first documented disease progression or death from any cause, assessed up to 3 years.
  • Neck control rate [ Time Frame: 3 years ]
    from date of enrollment until date of first documented neck relapse, assessed up to 3 years.
  • overall survival rate [ Time Frame: 3 years ]
    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) [ Time Frame: 2 months ]
    Acute toxicities(gastrointestinal toxicities,hematologic toxicities, dysphagia,oral mucositis) during the course of radiotherapy
Original Secondary Outcome Measures  ICMJE
 (submitted: May 5, 2016)
  • Disease-free survival [ Time Frame: 2 years ]
    from date of enrollment until date of first documented disease progression or death from any cause, assessed up to 2 years.
  • Neck control rate [ Time Frame: 2 years ]
    from date of enrollment until date of first documented neck relapse, assessed up to 2 years.
  • overall survival rate [ Time Frame: 2 years ]
    from date of enrollment until date of first death from any cause, assessed up to 2 years.
  • Quality of life [ Time Frame: 2 years ]
    change in Qol scores since the beginning of radiotherapy to 2 years after radiotherpy
  • Acute toxicities(gastrointestinal toxicities,hematologic toxicities, dysphagia,oral mucositis) [ Time Frame: 2 months ]
    Acute toxicities(gastrointestinal toxicities,hematologic toxicities, dysphagia,oral mucositis) during the course of radiotherapy
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Elective Mucosal Irradiation in Head-and-Neck Cancer of Unknown Primary
Official Title  ICMJE Elective Mucosal Irradiation in Head-and Neck Cancer of Unknown Primary, A Single Arm Phase II Trial
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Head-and-neck Cancer
  • Carcinoma of Unknown Primary
Intervention  ICMJE Radiation: Elective mucosal irradiaton
Patients will elective mucosal irradiaton based on nodal station, EBV/HPV status, RPN status etc. IMRT will be adopted.
Study Arms  ICMJE Experimental: EMI group
Elective mucosal irradiation
Intervention: Radiation: Elective mucosal irradiaton
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 7, 2019)
48
Original Estimated Enrollment  ICMJE
 (submitted: May 5, 2016)
40
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date January 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Guopei Zhu, M.D. antica@gmail.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02764216
Other Study ID Numbers  ICMJE 1501160-4
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Guopei Zhu, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Study Sponsor  ICMJE Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Collaborators  ICMJE Shanghai Jiao Tong University School of Medicine
Investigators  ICMJE Not Provided
PRS Account Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP