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
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Short-term treatment response of all patients
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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).
干预措施: Apatinib (Drug)
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).
干预措施: Particle Therapy (Radiation)
Particle Therapy
Participants will receive particle radiotherapy alone (proton: 56 GyE/28 Fx, plus carbon: 15 GyE/5 Fx for boost).
干预措施: Particle Therapy (Radiation)
结局指标
主要结局
Short-term treatment response of all patients
时间窗: Three months after completion of particle therapy.
次要结局
- Overall survival of all patients(From the diagnosis of H&N adenoid cystic carcinoma, a median of 3 years.)
- Progression-free survival of all patients(From the completion of the particle therapy, a median of 3 years.)
- Local progression-free survival of all patients(From the completion of the particle therapy, a median of 3 years.)
- Number of participants with treatment-related adverse events as assessed by NCI CTCAE v4.03(Time interval from start to 3 months after completion of particle therapy.)
- Distant metastasis-free survival of all patients(From the completion of the particle therapy, a median of 3 years.)
研究者
Jiade J. Lu
Executive Vice President of Shanghai Proton and Heavy Ion Center
Shanghai Proton and Heavy Ion Center