NCT05860868

Two Cycles VS Three Cycles Induction Chemotherapy in T1-4N2-3 Locally Advanced Nasopharyngeal Carcinoma

Two Cycles VS Three Cycles Induction Chemotherapy Plus Concurrent Chemoradiotherapy in T1-4N2-3 Locally Advanced Nasopharyngeal Carcinoma

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 474 (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 2 cycles induction chemotherapy combined with concurrent chemoradiotherapy is not inferior to 3 cycles induction chemotherapy combined with concurrent chemoradiotherapy in patients with locally advanced nasopharyngeal carcinoma.

Conditions

• Locally Advanced Nasopharyngeal Carcinoma

Interventions

Type	Name	Description
DRUG	2 cycles induction chemotherapy	Drug: 2 cycles 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).
DRUG	3 cycles induction chemotherapy	Drug: 3 cycles 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: 2023-05-01
• Primary completion: 2028-05-01
• Completion: 2030-05-01
• First posted: 2023-05-16
• Last updated: 2023-05-16

Locations

1 site across 1 country: China