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

Shanghai Proton and Heavy Ion Center50 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Adenoid Cystic Carcinoma

Interventions

ApatinibDRUG

Apatinib will be used as induction therapy in experimental arm.

Particle TherapyRADIATION

Same total dose and fractionation will be used in both arms.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Shanghai Proton and Heavy Ion Center

Shanghai, Shanghai Municipality, China

RECRUITING

Outcomes

Primary Outcomes

Short-term treatment response of all patients

Time frame: Three months after completion of particle therapy.

Secondary Outcomes

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.

Central Contacts

Lin Kong, MD

CONTACT

lin.kong@sphic.org.cn

Jiyi Hu, MD

CONTACT

jiyi.hu@sphic.org.cn

Data from ClinicalTrials.gov

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