Trail Evaluating Particle Therapy With or Without Apatinib for H&N Adenoid Cystic Carcinoma
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ClinicalTrials.gov Identifier: NCT02942693 |
Recruitment Status : Unknown
Verified August 2018 by Jiade J. Lu, Shanghai Proton and Heavy Ion Center.
Recruitment status was: Recruiting
First Posted : October 24, 2016
Last Update Posted : September 28, 2018
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Sponsor:
Shanghai Proton and Heavy Ion Center
Information provided by (Responsible Party):
Jiade J. Lu, Shanghai Proton and Heavy Ion Center
Tracking Information | ||||
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First Submitted Date ICMJE | October 18, 2016 | |||
First Posted Date ICMJE | October 24, 2016 | |||
Last Update Posted Date | September 28, 2018 | |||
Actual Study Start Date ICMJE | November 2016 | |||
Estimated Primary Completion Date | August 2019 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Short-term treatment response of all patients [ Time Frame: Three months after completion of particle therapy. ] | |||
Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Trail Evaluating Particle Therapy With or Without Apatinib for H&N Adenoid Cystic Carcinoma | |||
Official Title ICMJE | 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 | |||
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. | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Adenoid Cystic Carcinoma | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Unknown status | |||
Estimated Enrollment ICMJE |
50 | |||
Original Estimated Enrollment ICMJE | Same as current | |||
Estimated Study Completion Date ICMJE | December 2019 | |||
Estimated Primary Completion Date | August 2019 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 65 Years (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | China | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT02942693 | |||
Other Study ID Numbers ICMJE | SPHIC-TR-HNCNS-2016-08 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE |
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Responsible Party | Jiade J. Lu, Shanghai Proton and Heavy Ion Center | |||
Study Sponsor ICMJE | Shanghai Proton and Heavy Ion Center | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Shanghai Proton and Heavy Ion Center | |||
Verification Date | August 2018 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |