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Trail Evaluating Particle Therapy With or Without Apatinib for H&N Adenoid Cystic Carcinoma

Adenoid Cystic Carcinoma Clinical Trial

Official title:
A Phase II Randomized Trial of Efficacy and Safety of Particle Therapy With or Without Apatinib as Induction Therapy for Treatment of Head and Neck Adenoid Cystic Carcinoma

Clinical Trial Summary

It is a randomized phase II study to determine the efficacy and safety of particle therapy with or without apatinib as induction therapy for the treatment of head and neck adenoid cystic carcinoma. Participants will be randomized to arm 1: receiving apatinib for 6 weekly followed by particle radiotherapy; arm 2: particle radiotherapy alone.

Clinical Trial Description

The purpose of this study is to determine the efficacy and safety of particle therapy with or without apatinib as induction therapy for the treatment of head and neck adenoid cystic carcinoma. It is a randomized phase II clinical trial with single phase and 2 experimental arms. Participants will be randomized to arm 1, receiving apatinib (0.5g, daily) for 6 weekly followed by particle radiotherapy (proton: 56 GyE/28 Fx, plus carbon: 15 GyE/5 Fx for boost); arm 2: particle radiotherapy alone (proton: 56 GyE/28 Fx, plus carbon: 15 GyE/5 Fx for boost). The short term response will be evaluated using RECIST criteria. And the acute and late toxicities will be evaluated according to NCI CTCAE v4.03. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02942693
Study type Interventional
Source Shanghai Proton and Heavy Ion Center
Contact Lin Kong, MD
Email lin.kong@sphic.org.cn
Status Recruiting
Phase Phase 2
Start date November 2016
Completion date December 2019
View Details
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