Shanghai ninth people's hospital
Shanghai, Shanghai Municipality, 200011, China
NCT Number: NCT02776163
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.
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Notify Me18 year–70 year
All sexes
Interventional
Phase 2
Shanghai, Shanghai Municipality, 200011, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
nedaplatin 35mg/m^2,D1-2,2 cycles
Docetaxel 70mg/m^2,D1,2 cycles
a total dose of 60-66Gy in 30-33 fractions over 6-7 weeks
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
Time frame: 2 years
from date of enrollment until date of first death from any cause, assessed up to 2 years
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
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
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
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Other
Postoperative Concurrent Chemoradiotherapy in Treating Patients With High-Risk Salivary Gland Carcinomas of Head and Neck, A Non-Randomized, Phase II Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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