NCT02500940

Comparison the Effects of Different Neoadjuvant Chemotherapy Regimen on Acute Toxicity, Tumor Response, and Survival in Patients With Advanced Nasopharyngeal Carcinoma

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 54 (estimated)
• Sponsor: Taichung Veterans General Hospital · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to investigate the impact of different neoadjuvant chemotherapy schedules of cisplatin and 5-FU on acute toxicity, tumor response, and long-term survival in patients with advanced nasopharyngeal carcinoma

Detailed description

Control group: Neoadjuvant chemotherapy with tri-weekly PF × 3 cycles (cisplatin 100 mg/m2, day 1, followed by 5-FU 1000 mg/m2/d, days 1-4 continuous iv infusion, repeated every 3 weeks) + IMRT ≧ 70 Gy/35 fractions Test group: Neoadjuvant chemotherapy with weekly P-FL × 10 weeks (cisplatin 60 mg/m2 at days 1, 15, 29, 43, 57; alternatively with 5-FU 2500 mg/m2 + Leucovorin 250 mg/m2 at days 8, 22, 36, 50, 64) + IMRT ≧ 70 Gy/35 fractions

Conditions

• Nasopharyngeal Carcinoma

Interventions

Type	Name	Description
DRUG	Cisplatin	Neoadjuvant chemotherapy regimen with cisplatin
DRUG	Fluorouracil	Neoadjuvant chemotherapy regimen with Fluorouracil
RADIATION	Radiation therapy	Intensity-Modulated Radiation Therapy
DRUG	Leucovorin	Neoadjuvant chemotherapy regimen with Leucovorin

Timeline

• Start date: 2015-05-01
• Primary completion: 2016-05-01
• Completion: 2021-05-01
• First posted: 2015-07-17
• Last updated: 2015-07-17

Locations

1 site across 1 country: Taiwan