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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Adenoid Cystic Carcinoma

Intervention / Treatment
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* Drug: Apatinib
* Radiation: Particle Therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Apatinib with Particle Therapy<br>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). | Drug: Apatinib<br>* Apatinib will be used as induction therapy in experimental arm.<br>Radiation: Particle Therapy<br>* Same total dose and fractionation will be used in both arms.<br>|
| Experimental: Particle Therapy<br>Participants will receive particle radiotherapy alone (proton: 56 GyE/28 Fx, plus carbon: 15 GyE/5 Fx for boost). | Radiation: Particle Therapy<br>* Same total dose and fractionation will be used in both arms.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short-term treatment response of all patients |  | Three months after completion of particle therapy. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 
| 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. | 
| Distant metastasis-free survival of all patients |  | From the completion of the particle therapy, a median of 3 years. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Apatinib, Particle therapy