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

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

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.

Study Overview

• Status: Unknown
• Conditions: Adenoid Cystic Carcinoma
• Intervention / Treatment: Drug: Apatinib; Radiation: Particle Therapy

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
• Enrollment (Anticipated): 50
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 201315
      • Recruiting
      • Shanghai Proton and Heavy Ion Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Short-term treatment response of all patients	Three months after completion of particle therapy.

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Shanghai Proton and Heavy Ion Center

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2016
• Primary Completion (Anticipated): August 1, 2019
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: October 18, 2016
• First Submitted That Met QC Criteria: October 20, 2016
• First Posted (Estimate): October 24, 2016

Study Record Updates

• Last Update Posted (Actual): September 28, 2018
• Last Update Submitted That Met QC Criteria: September 26, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: Apatinib; Particle therapy
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Carcinoma; Carcinoma, Adenoid Cystic; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Apatinib
• Other Study ID Numbers: SPHIC-TR-HNCNS-2016-08

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided