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

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Brief Title

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

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 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 Phase

Phase 2

Study Type

Interventional


Primary Outcome

Short-term treatment response of all patients

Secondary Outcome

 Number of participants with treatment-related adverse events as assessed by NCI CTCAE v4.03

Condition

Adenoid Cystic Carcinoma

Intervention

Apatinib

Study Arms / Comparison Groups

 Apatinib with Particle Therapy
Description:  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).

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

50

Start Date

November 2016

Completion Date

December 2019

Primary Completion Date

August 2019

Eligibility Criteria

        Inclusion Criteria:

          -  Pathologically confirmed ACC

          -  Inoperable disease or postoperative residual disease detected by imaging studies

          -  Age ≥ 18 and ≤ 65 years of age

          -  ECOG < 2, no significant active concurrent medical illnesses

          -  Adequate laboratory values within 30 dyas of enrollment to study defined as follows: N
             > 2000/mm^3; PLT > 100,000/mm^3; total bilirubin < 1.5mg/dl; AST/ALT < 1.5 ULN; SCr <
             1.5mg/dl; CCR > 60ml/min

          -  Willing to accept adequate contraception for women with childbearing potential

          -  Ability to understand character and individual consequences of the clinical trial

          -  Willing to sign the written informed consent; Informed consent must be signed before
             the enrollment in the trial

        Exclusion Criteria:

          -  Presence of distant metastasis

          -  Pregnant or lactating women

          -  A diagnosis of malignancy other than CIS of the cervix, BCC and SCC of the skin within
             the past 5 years

          -  Refusal of the patient to participate into the study
      

Gender

All

Ages

18 Years - 65 Years

Accepts Healthy Volunteers

No

Contacts

Jiade J Lu, MD, , [email protected]

Location Countries

China

Location Countries

China

Administrative Informations


NCT ID

NCT02942693

Organization ID

SPHIC-TR-HNCNS-2016-08


Responsible Party

Principal Investigator

Study Sponsor

Shanghai Proton and Heavy Ion Center


Study Sponsor

Jiade J Lu, MD, Principal Investigator, Shanghai Proton and Heavy Ion Center,Shanghai, SPHIC


Verification Date

August 2018