Clinical Trial: Postoperative Concurrent Chemoradiotherapy in Treating Patients With High-Risk Malignant Salivary Gland Tumors
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Postoperative Concurrent Chemoradiotherapy in Treating Patients With High-Risk Malignant Salivary Gland Tumors of Head and Neck, A Non-Randomized, Phase II Trial
Brief Summary: This is a non-randomized, phase II, open label study of postoperative current chemoradiotherapy for high-risk malignant salivary gland tumors of head and neck.The primary purpose of this study is to evaluate the efficacy and safety of concurrent chemoradiotherapy in these patients.
Detailed Summary:
Sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Current Primary Outcome: Disease-free survival [ Time Frame: 2 years ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Overall survival rate [ Time Frame: 2 years ]from date of enrollment until date of first death from any cause, assessed up to 2 years
- Acute toxicity profiles, graded according to the NCI CTCAE version 3.0 [ Time Frame: up to 6 weeks ]Number of participants with treatment-related acute toxicity as assessed weekly by CTCAE v3.0 during the course of treatment
- Late toxicity profiles, graded according to the NCI CTCAE version 3.0 [ Time Frame: up to 2 years ]Number of participants with treatment-related late toxicity as assessed every 3 months by CTCAE v3.0 up to 2 years
- Score of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Head and Neck Core 35 (EORTC QLQ-HN35) during the concurrent treatment [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 6 weeks ]QoL score will be documented on each weekend during the course of radiotherapy
Original Secondary Outcome: Same as current
Information By: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Dates:
Date Received: May 12, 2016
Date Started: June 2016
Date Completion: December 2019
Last Updated: September 30, 2016
Last Verified: September 2016