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

NCT02942693 | Unknown Phase 2 DMC

• 1 other identifier: SPHIC-TR-HNCNS-2016-08
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Adenoid Cystic Carcinoma

Keywords

Apatinib; Particle therapy

Outcome Measures

Primary Outcomes (1)

• Short-term treatment response of all patients

  Three months after completion of particle therapy.

Secondary Outcomes (5)

• 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.

Study Arms (2)

Apatinib with Particle Therapy

EXPERIMENTAL

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; Radiation: Particle Therapy

Particle Therapy

EXPERIMENTAL

Participants will receive particle radiotherapy alone (proton: 56 GyE/28 Fx, plus carbon: 15 GyE/5 Fx for boost).

Radiation: Particle Therapy

Interventions

Apatinib DRUG

Apatinib will be used as induction therapy in experimental arm.

Apatinib with Particle Therapy

Particle Therapy RADIATION

Same total dose and fractionation will be used in both arms.

Apatinib with Particle Therapy; Particle Therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Proton and Heavy Ion Center: lead

Study Sites (1)

Shanghai Proton and Heavy Ion Center

Shanghai, Shanghai Municipality, 201315, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Adenoid Cystic

Interventions

apatinib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Jiade J Lu, MD

  Shanghai Proton and Heavy Ion Center,Shanghai, SPHIC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lin Kong, MD

CONTACT

lin.kong@sphic.org.cn

Jiyi Hu, MD

CONTACT

jiyi.hu@sphic.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Executive Vice President of Shanghai Proton and Heavy Ion Center

Study Record Dates

• First Submitted: October 18, 2016
• First Posted: October 24, 2016
• Study Start: November 1, 2016
• Primary Completion: August 1, 2019
• Study Completion: December 1, 2019
• Last Updated: September 28, 2018

Record last verified: 2018-08

Locations

CN (1)