NCT04528394

Proton Versus Photon Radiotherapy for Nasopharyngeal Carcinoma

A Randomized Phase II Trial Evaluating Toxicity and Efficacy Between Proton and Photon for Nasopharyngeal Carcinoma

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 136 (estimated)
• Sponsor: Shanghai Proton and Heavy Ion Center · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare the toxicity and therapeutic efficacy of proton or photon combined with carbon ion radiotherapy for newly diagnosed nasopharyngeal carcinoma.Participants will be randomized to 2 arms. Arm 1, participants received photon combined with carbon ion radiotherapy group, Arm 2, participants received proton combined with carbon ion radiotherapy.

Detailed description

The purpose of this study is to compare the toxicity and therapeutic efficacy of photon or proton combined with carbon ion radiotherapy for newly diagnosed nasopharyngeal carcinoma.Participants will be randomized to 2 arms. Arm 1 participants received photon combined with carbon ion radiotherapy (photon: 56 Gy/28 Fx, plus carbon: 15-17.5 gray equivalent \[GyE\]/5 Fx for boost). Arm 2, participants received proton combined with carbon ion radiotherapy (proton: 56 GyE/28 Fx, plus carbon: 15-17.5 GyE/5 Fx for boost). Adverse events will be documented according to CTCAE v4.03.The response of treatment will be evaluated according to RECIST criteria.

Conditions

• Nasopharyngeal Carcinoma

Interventions

Type	Name	Description
RADIATION	Photon	Photon combined with Carbon ion in Arm 1
RADIATION	Proton	Proton combined with Carbon ion in Arm 2
RADIATION	Carbon ion	Same dose and fractionation will be used in both arms.

Timeline

• Start date: 2019-04-29
• Primary completion: 2021-06-30
• Completion: 2022-06-30
• First posted: 2020-08-27
• Last updated: 2020-08-27

Locations

1 site across 1 country: China