We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Information provided by (Responsible Party):
Jiade J. Lu, Shanghai Proton and Heavy Ion Center

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Adenoid Cystic Carcinoma Drug: Apatinib Radiation: Particle Therapy Phase 2

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : November 2016
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Adenoids

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: 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).
 Drug: Apatinib
Apatinib will be used as induction therapy in experimental arm.

Radiation: Particle Therapy
Same total dose and fractionation will be used in both arms.
Experimental: Particle Therapy
Participants will receive particle radiotherapy alone (proton: 56 GyE/28 Fx, plus carbon: 15 GyE/5 Fx for boost).
 Radiation: Particle Therapy
Same total dose and fractionation will be used in both arms.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Short-term treatment response of all patients [ Time Frame: Three months after completion of particle therapy. ]

Secondary Outcome Measures :
  1. Number of participants with treatment-related adverse events as assessed by NCI CTCAE v4.03 [ Time Frame: Time interval from start to 3 months after completion of particle therapy. ]
  2. Overall survival of all patients [ Time Frame: From the diagnosis of H&N adenoid cystic carcinoma, a median of 3 years. ]
  3. Progression-free survival of all patients [ Time Frame: From the completion of the particle therapy, a median of 3 years. ]
  4. Local progression-free survival of all patients [ Time Frame: From the completion of the particle therapy, a median of 3 years. ]
  5. Distant metastasis-free survival of all patients [ Time Frame: From the completion of the particle therapy, a median of 3 years. ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02942693


Contacts
Layout table for location contacts
Contact: Lin Kong, MD lin.kong@sphic.org.cn
Contact: Jiyi Hu, MD jiyi.hu@sphic.org.cn

Locations
Layout table for location information
China, Shanghai
Shanghai Proton and Heavy Ion Center Recruiting
Shanghai, Shanghai, China, 201315
Contact: Lin Kong, MD       lin.kong@sphic.org.cn   
Contact: Jiyi Hu, MD       jiyi.hu@sphic.org.cn   
Principal Investigator: Jiade J Lu, MD         
Sponsors and Collaborators
Shanghai Proton and Heavy Ion Center
Investigators
Layout table for investigator information
Principal Investigator: Jiade J Lu, MD Shanghai Proton and Heavy Ion Center,Shanghai, SPHIC
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Jiade J. Lu, Executive Vice President of Shanghai Proton and Heavy Ion Center, Shanghai Proton and Heavy Ion Center
ClinicalTrials.gov Identifier: NCT02942693    
Other Study ID Numbers: SPHIC-TR-HNCNS-2016-08
First Posted: October 24, 2016    Key Record Dates
Last Update Posted: September 28, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Jiade J. Lu, Shanghai Proton and Heavy Ion Center:
Apatinib
Particle therapy
Additional relevant MeSH terms:
Layout table for MeSH terms
Carcinoma
Carcinoma, Adenoid Cystic
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
 Apatinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action