NCT05062005

ICCRT vs. CRT for Locally Advanced Nasopharyngeal Carcinoma

Induction Chemotherapy+Chemoradiotherapy vs. Chemoradiotherapy for Locally Advanced Nasopharyngeal Carcinoma

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 447 (estimated)
• Sponsor: First Affiliated Hospital, Sun Yat-Sen University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This trial is a multi-center phase III clinical trial. The purpose of this trial is to explore whether concurrent chemoradiotherapy is not inferior to induction chemotherapy combined with concurrent chemoradiotherapy in patients with locally advanced nasopharyngeal carcinoma.

Conditions

• Locally Advanced Nasopharyngeal Carcinoma

Interventions

Type	Name	Description
DRUG	Induction Chemotherapy	Induction regimens: TP (docetaxel 75 mg/m²; cisplatin 75 mg/m²) Q3w, TPF (docetaxel 60 mg/m²; cisplatin 60 mg/m²; 5-fluorouracil 600-750 mg/m² per day, continuous intravenous infusion d1-5) Q3w, or GP (gemcitabine: 1000 mg/m2 d1, d8; cisplatin 80 mg/m2) Q3w.
DRUG	Concurrent Chemotherapy	Cisplatin 100 mg/m², Q3w.
RADIATION	Definitive Radiotherapy	For all patients, the prescribed dose is 66-70 Gy (once a day, 5 times a week).

Timeline

• Start date: 2021-09-22
• Primary completion: 2027-08-31
• Completion: 2027-08-31
• First posted: 2021-09-30
• Last updated: 2021-09-30

Locations

1 site across 1 country: China