NCT03668730

Reduced-dose Radiotherapy for Low-risk Stage III Patients With Nasopharyngeal Carcinoma

A Phase II Trial of Induction Chemotherapy Followed by Cisplatin With Low Dose vs. Standard Dose IMRT in Stage III Nasopharyngeal Carcinoma Patients With Pretreatment EBV DNA<4000 Copy/ml

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 215 (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 III nasopharyngeal carcinoma of pretreatment EBV DNA\<4000 copy/ml treated with induction chemotherapy followed by two different doses of intensity-modulated radiation therapy and cisplatin.

Detailed description

To explore the 2 year PFS of patients with stage III nasopharyngeal carcinoma of pretreatment EBV DNA\<4000 copy/ml treated with induction chemotherapy followed by reduced-dose radiation and cisplatin. The enrolled patients will receive 2 cycles of TPF regimen induction chemotherapy, if radiographic CR/PR and EBV DNA=0 after induction chemotherapy, the patients will be delivered by 60 Gy IMRT combined with 3 cycles of cisplatin concurrent chemotherapy. If radiographic SD/PD or EBV DNA\>0 after induction chemotherapy, the patients will receive a total of 70 Gy IMRT combined with 3 cycles of cisplatin concurrent chemotherapy. The included patients will be treated with 2 cycles of TPF regimen induction chemotherapy and 60Gy IMRT combined with cisplatin concurrent chemotherapy. The TPF regimen is consist of paclitaxel liposome 135mg/m2 d1, cisplatin 25mg/m2d1-d3 and 5-Fu 3750mg/m2 civ120h, with a total of two cycles. Concurrent cisplatin chemotherapy is delivered with dose of 100mg/m2, a total of three cycles. The third cycle of cisplatin concurrent chemotherapy is allowed to be delivered within one week after IMRT finished.

Conditions

• Nasopharyngeal Carcinoma

Interventions

Type	Name	Description
RADIATION	Intensity-modulated radiation therapy	Patients undergo low-dose OR standard dose IMRT based on their radiographic response to induction chemotherapy
DRUG	Paclitaxel liposome	Patients receive Paclitaxel liposome by 135mg/m2 with a total of two cycles.
DRUG	Cisplatin	Patients receive Cisplatin by 25mg/m2 on day1-day3 with a total of two cycles as induction chemotherapy ; patients receive cisplatin by 100mg/m2 with a total of three cycles as concurrent chemotherapy.
DRUG	5-Fluorouracil	Patients receive 5-Fluorouracil by 3750mg/m2 civ120h with a total of three cycles.

Timeline

• Start date: 2018-10-19
• Primary completion: 2021-12-31
• Completion: 2023-12-30
• First posted: 2018-09-13
• Last updated: 2021-08-24

Locations

1 site across 1 country: China