Adenoid Cystic Carcinoma
Conditions
Keywords
Apatinib, Particle therapy
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.
Interventions
DRUGApatinib
Apatinib will be used as induction therapy in experimental arm.
RADIATIONParticle Therapy
Same total dose and fractionation will be used in both arms.
Sponsors
Shanghai Proton and Heavy Ion Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Short-term treatment response of all patients | Three months after completion of particle therapy. |
Secondary
| Measure | 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. |
Countries
China
Contacts
Primary ContactLin Kong, MD
Backup ContactJiyi Hu, MD
Outcome results
None listed