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

Sponsor
Shanghai Proton and Heavy Ion Center
Study ID
NCT02942693
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Apatinib — DRUG
    Apatinib will be used as induction therapy in experimental arm.
  • Particle Therapy — RADIATION
    Same total dose and fractionation will be used in both arms.

Study Details

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.

Key Dates

Start date
Nov 30, 2016
Status verified
Aug 2018
Primary completion
Aug 31, 2019
Completion
Dec 31, 2019

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Apatinib with Particle Therapy
    Participants will receive apatinib (0.5g, daily) for 6 weekly followed by particle radiotherapy (proton: 56 GyE/28 Fx, plus carbon: 15 GyE/5 Fx for boost).
  • Experimental: Particle Therapy
    Participants will receive particle radiotherapy alone (proton: 56 GyE/28 Fx, plus carbon: 15 GyE/5 Fx for boost).

Primary Outcome Measure

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

Central Contacts

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