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