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

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

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

Brief 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.

Detailed Summary: 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.
Sponsor: Shanghai Proton and Heavy Ion Center

Current Primary Outcome: Short-term treatment response of all patients [ Time Frame: Three months after completion of particle therapy. ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Number of participants with treatment-related adverse events as assessed by NCI CTCAE v4.03 [ Time Frame: Time interval from start to 3 months after completion of particle therapy. ]
  • Overall survival of all patients [ Time Frame: From the diagnosis of H&N adenoid cystic carcinoma, a median of 3 years. ]
  • Progression-free survival of all patients [ Time Frame: From the completion of the particle therapy, a median of 3 years. ]
  • Local progression-free survival of all patients [ Time Frame: From the completion of the particle therapy, a median of 3 years. ]
  • Distant metastasis-free survival of all patients [ Time Frame: From the completion of the particle therapy, a median of 3 years. ]


Original Secondary Outcome: Same as current

Information By: Shanghai Proton and Heavy Ion Center

Dates:
Date Received: October 18, 2016
Date Started: November 2016
Date Completion: December 2018
Last Updated: October 20, 2016
Last Verified: October 2016