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Currently, you can access the following clinical trials being conducted worldwide:
Clinicaltrials.gov identifier NCT03919552
Recruitment Status Recruiting
First Posted April 18, 2019
Last update posted April 18, 2019
The purpose of this study is to compare cisplatin-based with carboplatin-based chemoradiotherapy in patients with locoregionally advanced nasopharyngeal carcinoma (NPC), in order to confirm the value of carboplatin-based chemoradiotherapy in NPC patients.
Patients presented with non-keratinizing NPC and stage T3-4NxM0/TxN2-3M0 are randomly assigned to receive cisplatin-based (control arm) with carboplatin-based (investigational arm) chemoradiotherapy. Patients in the investigational arm receive docetaxel (75mg/m2 on day 1), carboplatin (AUC 4 on day 1) every three weeks for two cycles before the radiotherapy, and then receive radical radiotherapy and carboplatin (AUC 5 on day 1) every three weeks for three cycles during radiotherapy. Patients in the control arm receive docetaxel (75mg/m2 on day 1), cisplatin (75mg/m2 on day 1) every three weeks for two cycles before the radiotherapy, and then receive radical radiotherapy and cisplatin (100mg/m2 on day 1) every three weeks for three cycles during radiotherapy. Patients are stratified according to stage. The primary end point is overall survival (OS). Secondary end points include failure-free survival (FFS), distant failure-free survival (D-FFS), locoregional failure-free survival (LR-FFS), initial response rates after treatments and toxic effects. All efficacy analyses are conducted in the intention-to-treat population; the safety population include only patients who receive their randomly assigned treatment.
Patients receive docetaxel (75mg/m2 on day 1), carboplatin (AUC 4 on day 1) every three weeks for two cycles before the radiotherapy, and then receive radical radiotherapy and carboplatin (AUC 5 on day 1) every three weeks for three cycles during radiotherapy.
Patients receive docetaxel (75mg/m2 on day 1), carboplatin (AUC 4 on day 1) every three weeks for two cycles before the radiotherapy.
Radiation: Carboplatin-based concurrent chemoradiotherapy
Patients receive radical radiotherapy and carboplatin (AUC 5) every three weeks for three cycles during radiotherapy.
|Active Comparator: Cisplatin
Patients receive docetaxel (75mg/m2 on day 1), cisplatin (75mg/m2 on day 1) every three weeks for two cycles before the radiotherapy, and then receive radical radiotherapy and cisplatin (100mg/m2 on day 1) every three weeks for three cycles during radiotherapy.
Patients receive docetaxel (75mg/m2 on day 1), cisplatin (75mg/m2 on day 1) every three weeks for two cycles before the radiotherapy.
Radiation: Cisplatin-based concurrent chemoradiotherapy
Patients receive radical radiotherapy and cisplatin (100mg/m2) every three weeks for three cycles during radiotherapy.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, , Learn About Clinical Studies.-->
- Patients with newly histologically confirmed non-keratinizing (according to World
Health Organization (WHO) histologically type).
- Tumor staged as T3-4Nx/TxN2-3 (according to the 8th American Joint Commission on
- No evidence of distant metastasis (M0).
- Satisfactory performance status: Karnofsky scale (KPS) > 70.
- Adequate marrow: leucocyte count ≥4000/μL, hemoglobin ≥90g/L and platelet count
- Normal liver function test: Alanine Aminotransferase (ALT)、Aspartate Aminotransferase
(AST) <1.5×upper limit of normal (ULN) concomitant with alkaline phosphatase (ALP) ≤2.5×ULN, and bilirubin ≤ULN. - Adequate renal function: creatinine clearance ≥60 ml/min. - Patients must be informed of the investigational nature of this study and give written informed consent. Exclusion Criteria: - WHO Type keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma. - Age ≥65 years or 1.5×ULN), and emotional disturbance.
Contact: Jian Guan, Ph.D. +86-13632102247 email@example.com
Southern medical university
Nanfang Hospital of Southern Medical University
Study Chair: Jian Guan Nanfang Hospital of Southern Medical University
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