Trail Evaluating Particle Therapy With or Without Apatinib for H&N Adenoid Cystic Carcinoma
NCT ID: NCT02942693
Last Updated: 2018-09-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
50 participants
INTERVENTIONAL
2016-11-30
2019-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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).
Apatinib
Apatinib will be used as induction therapy in experimental arm.
Particle Therapy
Same total dose and fractionation will be used in both arms.
Particle Therapy
Participants will receive particle radiotherapy alone (proton: 56 GyE/28 Fx, plus carbon: 15 GyE/5 Fx for boost).
Particle Therapy
Same total dose and fractionation will be used in both arms.
Interventions
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Apatinib
Apatinib will be used as induction therapy in experimental arm.
Particle Therapy
Same total dose and fractionation will be used in both arms.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
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Shanghai Proton and Heavy Ion Center
OTHER
Responsible Party
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Jiade J. Lu
Executive Vice President of Shanghai Proton and Heavy Ion Center
Principal Investigators
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Jiade J Lu, MD
Role: PRINCIPAL_INVESTIGATOR
Shanghai Proton and Heavy Ion Center,Shanghai, SPHIC
Locations
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Shanghai Proton and Heavy Ion Center
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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SPHIC-TR-HNCNS-2016-08
Identifier Type: -
Identifier Source: org_study_id
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