NCT03919552

Cisplatin-based and Carboplatin-based Chemoradiation in Locoregionally Advanced Nasopharyngeal Carcinoma

Intensity-modulated Radiation Therapy Combined With Cisplatin-based or Carboplatin-based Chemotherapy in Locoregionally Advanced Nasopharyngeal Carcinoma：: A Phase 3 Trial

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 482 (estimated)
• Sponsor: Nanfang Hospital, Southern Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Cisplatin
• Carboplatin
• NPC

Interventions

Type	Name	Description
DRUG	Docetaxel,Carboplatin	Patients receive docetaxel (75mg/m2 on day 1), carboplatin (AUC 4 on day 1) every three weeks for two cycles before the radiotherapy.
DRUG	Docetaxel,Cisplatin	Patients receive docetaxel (75mg/m2 on day 1), cisplatin (75mg/m2 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.
RADIATION	Cisplatin-based concurrent chemoradiotherapy	Patients receive radical radiotherapy and cisplatin (100mg/m2) every three weeks for three cycles during radiotherapy.

Timeline

• Start date: 2018-01-31
• Primary completion: 2025-12-31
• Completion: 2026-12-31
• First posted: 2019-04-18
• Last updated: 2023-06-18

Locations

1 site across 1 country: China