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 ]

from date of enrollment until date of first documented disease progression or death from any cause, assessed up to 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