NCT04136886

Concurrent Chemotherapy for Recurrent T3/T4 Nasopharyngeal Carcinoma

Intensity-modulated Radiotherapy Plus Concurrent Chemotherapy Versus Intensity-modulated Radiotherapy Alone In Patients With rT3/T4 Locally Advanced Recurrent Nasopharyngeal Carcinoma: A Phase 3 Multicenter Prospective Randomised Controlled Trial (IMRT)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 346 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether concurrent chemotherapy and IMRT is effective in the treatment of locally stage T3/T4 recurrent nasopharyngeal carcinoma patients compared with IMRT alone.

Detailed description

Locally T3/T4 recurrent nasopharyngeal carcinoma (NPC) may be salvaged by intensity modulated-radiotherapy (IMRT), but local control is not good enough and late toxicities is usually severe The aim of this phase III randomized controlled study is to address the efficacy of concurrent chemotherapy (cisplatin) with IMRT to improve local control and lower the occurrence of severe late toxicities compared with IMRT alone for locally T3/T4 recurrent NPC patients.

Conditions

• Nasopharyngeal Carcinoma

Interventions

Type	Name	Description
DRUG	Cisplatin	cisplatin is to give from the first Day of radiation therapy D1,D22 Q3W for 2 cycles Radiation: IMRT IMRT is to give 60Gy in 27 fraction
RADIATION	IMRT	Radiation: IMRT IMRT is to give 60Gy in 27 fraction

Timeline

• Start date: 2020-01-01
• Primary completion: 2027-12-01
• Completion: 2027-12-01
• First posted: 2019-10-23
• Last updated: 2019-10-23

Locations

1 site across 1 country: China