A Phase 2 interventional study of Cisplatin 2 and Docetaxel in Nasopharyngeal Carcinoma, sponsored by Sun Yat-sen University. Status unknown at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2016-05-26.
Sponsored by Sun Yat-sen University · Phase 2, Interventional, and Treatment
The investigators aim to evaluate the efficiency and toxicities of concurrent docetaxel and cisplatin with intensity-modulated radiotherapy in high risk locoregionally advanced nasopharyngeal carcinoma.
Eligible patients are randomly assigned to receive intensity-modulated radiotherapy (IMRT) with concurrent chemotherapy of docetaxel plus cisplatin or cisplatin alone. IMRT is delivered with a total dose of 68 Gy or higher in 33 fractions to the primary tumor. Concurrent chemotherapy in the experimental arm consists of docetaxel 60 mg/m², D1 and cisplatin 25 mg/m², D1-3 every 3 weeks for 3 cycles. Concurrent chemotherapy in the control arm consists of cisplatin 100 mg/m², D1 every 3 weeks for 3 cycles.The primary endpoint is overall survival (OS), defined as time from randomization to the day of death from any cause. Secondary end points include failure-free survival (FFS), locoregional relapse-free survival (LRFS), distant metastasis-free survival (DMFS) and the incidence of grade 3 or higher acute toxicities. All efficacy analyses are conducted in the intention-to-treat population, and the safety population include only patients who receive their randomly assigned treatment.
824 studies on the registry are indexed under Nasopharyngeal Carcinoma; 281 are open to participants now.
This study's planned enrollment of 130 is above the median of 84 across 674 interventional studies indexed under Nasopharyngeal Carcinoma.
Browse Nasopharyngeal Carcinoma studies →Sun Yat-sen University is the lead sponsor of 1,680 studies on the registry; 609 are open to participants now.
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Exclusion Criteria:
Concurrent chemotherapy: TP - Docetaxel 60mg/m2, D1 and cisplatin 25 mg/m2, D1-3 every 3 weeks for 3 cycles; Radiation: Intensity-modulated radiotherapy
Drug: Docetaxel · Drug: Cisplatin 1 · Radiation: Intensity-modulated radiotherapy
Concurrent chemotherapy: DDP - Cisplatin 100 mg/m2, D1 every 3 weeks for 3 cycles; Radiation: Intensity-modulated radiotherapy
Drug: Cisplatin 2 · Radiation: Intensity-modulated radiotherapy
Cisplatin 100 mg/m2, D1 every 3 weeks for 3 cycles
Also known as: DDP
Docetaxel 60 mg/m2, D1 every 3 weeks for 3 cycles
Also known as: T
Cisplatin 25 mg/m2, D1-3 every 3 weeks for 3 cycles
Also known as: P
Intensity-modulated radiotherapy
Also known as: IMRT
overall survival
Time frame: two year
failure-free survival
Time frame: two year
distant metastasis-free survival
Time frame: two year
locoregional relapse-free survival
Time frame: two year
Number of participants with treatment-related acute adverse events as assessed by CTCAE v4.0
Time frame: up to two months
This study is status unknown, as verified in May 2016. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Docetaxel