A Phase 2 interventional study of Nedaplatin and Docetaxel in Salivary Gland Tumors and Head and Neck Cancer, sponsored by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University. Completed at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-07-30.
Sponsored by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University · Phase 2, Interventional, and Treatment
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.
2,344 studies on the registry are indexed under Head and Neck Neoplasms; 551 are open to participants now.
This study's enrollment of 107 is above the median of 47 across 1,751 interventional studies indexed under Head and Neck Neoplasms.
Browse Head and Neck Neoplasms studies →Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University is the lead sponsor of 160 studies on the registry; 70 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adequate organ function including the following:
Exclusion Criteria:
Intensity-modulated radiotherapy+concurrent chemotherapy with docetaxel and Nedaplatin
Drug: Nedaplatin · Drug: Docetaxel · Radiation: Intensity-modulated radiotherapy
Intensity-modulated radiotherapy+concurrent chemotherapy with docetaxel and Nedaplatin
Drug: Nedaplatin · Drug: Docetaxel · Radiation: Intensity-modulated radiotherapy
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
Disease-free survival
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
Overall survival rate
from date of enrollment until date of first death from any cause, assessed up to 2 years
Time frame: 2 years
Acute toxicity profiles, graded according to the NCI CTCAE version 3.0
Number of participants with treatment-related acute toxicity as assessed weekly by CTCAE v3.0 during the course of treatment
Time frame: up to 6 weeks
Late toxicity profiles, graded according to the NCI CTCAE version 3.0
Number of participants with treatment-related late toxicity as assessed every 3 months by CTCAE v3.0 up to 2 years
Time frame: 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
QoL score will be documented on each weekend during the course of radiotherapy
Time frame: participants will be followed for the duration of hospital stay, an expected average of 6 weeks
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University