NCT05304468

Reduced-dose Versus Standard Dose Radiotherapy for Nasopharyngeal Carcinomain

Phase III Randomized Non-inferiority Trial of Reduced-dose Versus Standard Dose Radiotherapy for Stage II-III Nasopharyngeal Carcinoma Which Have Favorable Response After Induction Chemotherapy

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 452 (actual)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

To study the 2-year PFS (progression-free survival) of patients with stage II-III nasopharyngeal carcinoma treated with induction chemotherapy followed by two different doses of intensity modulated radiation therapy plus concurrent cisplatin chemotherapy

Detailed description

To explore the 2 year PFS of patients with stageII-III nasopharyngeal carcinoma treated with induction chemotherapy followed by reduced-dose radiotherapy and cisplatin versus standard dose radiotherapy plus cisplatin concurrent chemotherapy. The enrolled patients will receive 2 cycles of cisplatin-based induction chemotherapy, if radiographic CR/PR and EBV DNA=0 after induction chemotherapy, the patients will be randomised assigned to received 60 Gy IMRT combined with 2 cycles of cisplatin concurrent chemotherapy or 70Gy IMRT combined with 3 cycles of cisplatin concurrent chemotherapy.

Conditions

• Nasopharyngeal Carcinoma

Interventions

Type	Name	Description
RADIATION	IMRT	Patients in experimental group received reduced dose IMRT
DRUG	induction chemotherapy	cisplatin-based induction chemotherapy for two cycles
DRUG	cisplatin concurrent chemotherapy	cisplatin 100mg/m2, for two(60Gy) or three cycles(70Gy)

Timeline

• Start date: 2022-05-11
• Primary completion: 2026-10-29
• Completion: 2029-10-29
• First posted: 2022-03-31
• Last updated: 2025-03-21

Locations

1 site across 1 country: China