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

Adenoid Cystic Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02942693
• Other study ID #: SPHIC-TR-HNCNS-2016-08
• Status: Recruiting
• Phase: Phase 2
• Start date: November 2016
• Est. completion date: December 2019

Study information

• Verified date: August 2018
• Source: Shanghai Proton and Heavy Ion Center
• Contact: Lin Kong, MD
• Email: lin.kong[@]sphic.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2019
• Est. primary completion date: August 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Adenoid Cystic Carcinoma
• Carcinoma
• Carcinoma, Adenoid Cystic

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.

Locations

Country	Name	City	State
China	Shanghai Proton and Heavy Ion Center	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Proton and Heavy Ion Center

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Short-term treatment response of all patients		Three months after completion of particle therapy.
Secondary	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.
Secondary	Overall survival of all patients		From the diagnosis of H&N adenoid cystic carcinoma, a median of 3 years.
Secondary	Progression-free survival of all patients		From the completion of the particle therapy, a median of 3 years.
Secondary	Local progression-free survival of all patients		From the completion of the particle therapy, a median of 3 years.
Secondary	Distant metastasis-free survival of all patients		From the completion of the particle therapy, a median of 3 years.