drugset / Trial / NCT01479504
A Multicenter Trial Evaluating the Efficacy of Nedaplatin in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma
Phase 3
Unknown
2 enrolled
Guangxi Medical University
303rd Hospital of the People's Liberation Army · collabFirst People's Hospital of Yulin · collabGuangxi Naxishan Hospital · collabGuangxi Traditional Chinese Medical University · collabGuigang People's Hospital · collabGuilin Medical College · collabLiuZhou People's Hospital · collabLiuzhou Cancer Hospital · collabLiuzhou Hospital of Traditional Chinese Medicine · collabLiuzhou Railway hospital · collabLiuzhou Workers' Hospital · collabNanning Second People's Hospital · collabPeople's Hospital of Guangxi Zhuang Autonomous Region · collabThe Red Cross hospital of YuLin · collabWuzhou Red Cross Hospital · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
This study is a multicenter trial.The primary objective is to estimate short-term efficacy and acute toxicities of nedaplatin to the combination of docetaxel in neoadjuvant chemotherapy followed by nedaplatin in concurrent chemoradiotherapy, compared to cisplatin to the combination of docetaxel in neoadjuvant chemotherapy followed by cisplatin in concurrent chemoradiotherapy for patients with locoregionally advanced nasopharyngeal carcinoma. Secondary objectives are to evaluate the overall survival, the distant metastases free survival, and disease free survival of patients with locoregionally advanced nasopharyngeal carcinoma treated with these regimens.Furthermore,analyze the cost-effectiveness of the regimens.
Timeline
- Start
- 2011-11
- Primary completion
- 2012-11
- Completion
- 2017-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Cisplatin | Other / unclassified | 40 mg/m2 | — |
| Subject | Nedaplatin | Small molecule | 40 mg/m2 | — |
| Comparator | Docetaxel | Small molecule | 65 mg/m2 | — |