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

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ClinicalTrials.gov Identifier: NCT02942693
Recruitment Status : Not yet recruiting
First Posted : October 24, 2016
Last Update Posted : October 24, 2016
Sponsor:
Information provided by (Responsible Party):
Jiade J. Lu, Shanghai Proton and Heavy Ion Center

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 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
Study Start Date : November 2016
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Adenoids

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.




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. ]


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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

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

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 Posted: October 24, 2016    Key Record Dates
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