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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 : October 14, 2016
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

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
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
Study Start Date : January 2015
Estimated Primary Completion Date : January 2017
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Mucosal control rate [ Time Frame: 2 years ]
    from date of enrollment to date of first documented primary site emergence, assessed up to 2 years.


Secondary Outcome Measures :
  1. 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.

  2. Neck control rate [ Time Frame: 2 years ]
    from date of enrollment until date of first documented neck relapse, assessed up to 2 years.

  3. overall survival rate [ Time Frame: 2 years ]
    from date of enrollment until date of first death from any cause, assessed up to 2 years.

  4. Quality of life [ Time Frame: 2 years ]
    change in Qol scores since the beginning of radiotherapy to 2 years after radiotherpy

  5. 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



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02764216


Contacts
Contact: Guopei Zhu, M.D. antica@gmail.com

Locations
China, Shanghai
Shanghai ninth people's hospital Recruiting
Shanghai, Shanghai, China, 200011
Contact: Guopei Zhu, M.D.         
Fudan University Shanghai Cancer Center Recruiting
Shanghai, Shanghai, China, 200032
Contact: Guopei Zhu, M.D.    +8621 6417 5590    antica@gmail.com   
Principal Investigator: Guopei Zhu, M.D.         
Sponsors and Collaborators
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Shanghai Jiao Tong University School of Medicine

Responsible Party: Guopei Zhu, M.D., Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
ClinicalTrials.gov Identifier: NCT02764216     History of Changes
Other Study ID Numbers: 1501160-4
First Posted: May 6, 2016    Key Record Dates
Last Update Posted: October 14, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Head and Neck Neoplasms
Carcinoma
Neoplasms, Unknown Primary
Neoplasms by Site
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes