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

• ClinicalTrials.gov Identifier: NCT02942693
• Recruitment Status: Recruiting
• First Posted: October 24, 2016
• Last Update Posted: September 28, 2018
• Sponsor: Shanghai Proton and Heavy Ion Center
• Information provided by (Responsible Party): Jiade J. Lu, Shanghai Proton and Heavy Ion Center

Tracking Information

• First Submitted Date: October 18, 2016
• First Posted Date: October 24, 2016
• Last Update Posted Date: September 28, 2018
• Actual Study Start Date: November 2016
• Estimated Primary Completion Date: August 2019 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: October 20, 2016): Short-term treatment response of all patients [ Time Frame: Three months after completion of particle therapy. ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: October 20, 2016)

• 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. ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Adenoid Cystic Carcinoma

Intervention

• 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.

Study Arms

• 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).
  Interventions:

  • Drug: Apatinib
  • Radiation: Particle Therapy
• Experimental: Particle Therapy
  Participants will receive particle radiotherapy alone (proton: 56 GyE/28 Fx, plus carbon: 15 GyE/5 Fx for boost).
  Intervention: Radiation: Particle Therapy

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: October 20, 2016): 50
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 2019
• Estimated Primary Completion Date: August 2019 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Lin Kong, MD; lin.kong@sphic.org.cn

Contact: Jiyi Hu, MD; jiyi.hu@sphic.org.cn

• Listed Location Countries: China

Administrative Information

• NCT Number: NCT02942693
• Other Study ID Numbers: SPHIC-TR-HNCNS-2016-08
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Responsible Party: Jiade J. Lu, Shanghai Proton and Heavy Ion Center
• Study Sponsor: Shanghai Proton and Heavy Ion Center
• Collaborators: Not Provided

Investigators

• Principal Investigator: Jiade J Lu, MD; Shanghai Proton and Heavy Ion Center,Shanghai, SPHIC

• PRS Account: Shanghai Proton and Heavy Ion Center
• Verification Date: August 2018