Clinical trial NCT02942693: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Adenoid Cystic Carcinoma
Keywords: Apatinib
Particle therapy
Lead sponsor: Shanghai Proton and Heavy Ion Center
Sponsor class: OTHER
First posted: 2016-10-24
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Short-term treatment response of all patients
timeFrame: Three months after completion of particle therapy.
Secondary outcomes:
measure: Number of participants with treatment-related adverse events as assessed by NCI CTCAE v4.03
timeFrame: Time interval from start to 3 months after completion of particle therapy.
measure: Overall survival of all patients
timeFrame: From the diagnosis of H&N adenoid cystic carcinoma, a median of 3 years.
measure: Progression-free survival of all patients
timeFrame: From the completion of the particle therapy, a median of 3 years.
measure: Local progression-free survival of all patients
timeFrame: From the completion of the particle therapy, a median of 3 years.
measure: Distant metastasis-free survival of all patients
timeFrame: From the completion of the particle therapy, a median of 3 years.
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Proton and Heavy Ion Center
state: Shanghai
Study officials:
affiliation: Shanghai Proton and Heavy Ion Center,Shanghai, SPHIC
name: Jiade J Lu, MD
role: PRINCIPAL_INVESTIGATOR
References: