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
|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)|
|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|
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.
- Mucosal control rate [ Time Frame: 2 years ]from date of enrollment to date of first documented primary site emergence, assessed up to 2 years.
- 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
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
|Contact: Guopei Zhu, M.D.||firstname.lastname@example.org|
|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 email@example.com|
|Principal Investigator: Guopei Zhu, M.D.|