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

Primary Purpose

Adenoid Cystic Carcinoma

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Apatinib
Particle Therapy
Sponsored by
Shanghai Proton and Heavy Ion Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adenoid Cystic Carcinoma focused on measuring Apatinib, Particle therapy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Shanghai Proton and Heavy Ion CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Apatinib with Particle Therapy

Particle Therapy

Arm Description

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).

Participants will receive particle radiotherapy alone (proton: 56 GyE/28 Fx, plus carbon: 15 GyE/5 Fx for boost).

Outcomes

Primary Outcome Measures

Short-term treatment response of all patients

Secondary Outcome Measures

Number of participants with treatment-related adverse events as assessed by NCI CTCAE v4.03
Overall survival of all patients
Progression-free survival of all patients
Local progression-free survival of all patients
Distant metastasis-free survival of all patients

Full Information

First Posted
October 18, 2016
Last Updated
September 26, 2018
Sponsor
Shanghai Proton and Heavy Ion Center
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1. Study Identification

Unique Protocol Identification Number
NCT02942693
Brief Title
Trail Evaluating Particle Therapy With or Without Apatinib for H&N Adenoid Cystic Carcinoma
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Unknown status
Study Start Date
November 2016 (Actual)
Primary Completion Date
August 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Proton and Heavy Ion Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adenoid Cystic Carcinoma
Keywords
Apatinib, Particle therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Apatinib with Particle Therapy
Arm Type
Experimental
Arm Description
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).
Arm Title
Particle Therapy
Arm Type
Experimental
Arm Description
Participants will receive particle radiotherapy alone (proton: 56 GyE/28 Fx, plus carbon: 15 GyE/5 Fx for boost).
Intervention Type
Drug
Intervention Name(s)
Apatinib
Intervention Description
Apatinib will be used as induction therapy in experimental arm.
Intervention Type
Radiation
Intervention Name(s)
Particle Therapy
Intervention Description
Same total dose and fractionation will be used in both arms.
Primary Outcome Measure Information:
Title
Short-term treatment response of all patients
Time Frame
Three months after completion of particle therapy.
Secondary Outcome Measure Information:
Title
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.
Title
Overall survival of all patients
Time Frame
From the diagnosis of H&N adenoid cystic carcinoma, a median of 3 years.
Title
Progression-free survival of all patients
Time Frame
From the completion of the particle therapy, a median of 3 years.
Title
Local progression-free survival of all patients
Time Frame
From the completion of the particle therapy, a median of 3 years.
Title
Distant metastasis-free survival of all patients
Time Frame
From the completion of the particle therapy, a median of 3 years.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lin Kong, MD
Email
lin.kong@sphic.org.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Jiyi Hu, MD
Email
jiyi.hu@sphic.org.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jiade J Lu, MD
Organizational Affiliation
Shanghai Proton and Heavy Ion Center,Shanghai, SPHIC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai Proton and Heavy Ion Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
201315
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lin Kong, MD
Email
lin.kong@sphic.org.cn
First Name & Middle Initial & Last Name & Degree
Jiyi Hu, MD
Email
jiyi.hu@sphic.org.cn
First Name & Middle Initial & Last Name & Degree
Jiade J Lu, MD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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