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

This study is not yet open for participant recruitment.
Verified October 2016 by Jiade J. Lu, Shanghai Proton and Heavy Ion Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT02942693
First Posted: October 24, 2016
Last Update Posted: October 24, 2016
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Jiade J. Lu, Shanghai Proton and Heavy Ion Center
  Purpose
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 Intervention Phase
Adenoid Cystic Carcinoma Drug: Apatinib Radiation: Particle Therapy Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Jiade J. Lu, Shanghai Proton and Heavy Ion Center:

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

Secondary Outcome Measures:
  • 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. ]
  • Overall survival of all patients [ Time Frame: From the diagnosis of H&N adenoid cystic carcinoma, a median of 3 years. ]
  • Progression-free survival of all patients [ Time Frame: From the completion of the particle therapy, a median of 3 years. ]
  • Local progression-free survival of all patients [ Time Frame: From the completion of the particle therapy, a median of 3 years. ]
  • Distant metastasis-free survival of all patients [ Time Frame: From the completion of the particle therapy, a median of 3 years. ]

Estimated Enrollment: 50
Study Start Date: November 2016
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: July 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.
  Eligibility

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Ages Eligible for Study:   18 Years to 65 Years   (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
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
Contact: Lin Kong, MD lin.kong@sphic.org.cn
Contact: Jiyi Hu, MD jiyi.hu@sphic.org.cn

Sponsors and Collaborators
Shanghai Proton and Heavy Ion Center
Investigators
Principal Investigator: Jiade J Lu, MD Shanghai Proton and Heavy Ion Center,Shanghai, SPHIC
  More 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     History of Changes
Other Study ID Numbers: SPHIC-TR-HNCNS-2016-08
First Submitted: October 18, 2016
First Posted: October 24, 2016
Last Update Posted: October 24, 2016
Last Verified: October 2016
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:
Carcinoma
Carcinoma, Adenoid Cystic
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma