NCT02672995

Brief Summary

The investigators propose a new treatment strategy of fractionated stereotactic radiosurgery with concurrent bevacizumab for brain metastases. This phase I dose-escalation study is to establish the feasibility of this strategy and find the recommended doses.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 28, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 3, 2016

Completed
1.9 years until next milestone

Study Start

First participant enrolled

January 1, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

August 18, 2017

Status Verified

August 1, 2017

Enrollment Period

11 months

First QC Date

January 28, 2016

Last Update Submit

August 15, 2017

Conditions

Brain Neoplasm

Keywords

stereotactic radiosurgery,Bevacizumab

Outcome Measures

Primary Outcomes (1)

  • Maximum tolerated dose

    The maximum tolerated dose of fractionated stereotactic radiosurgery with concurrent bevacizumab for brain metastases.

    4 months

Secondary Outcomes (3)

  • Response rate

    4 months

  • Time to progression

    4 months

  • The incidence of radiation-induced adverse effects

    4 months

Study Arms (1)

Single arm dose-escalation

EXPERIMENTAL

Fractionated stereotactic radiosurgery: Group 1: tumors 1.5\~2.5 cm in diameter Dose level 1: 21 Gy in 3 fractions Dose level 2: 24 Gy in 3 fractions Dose level 3: 27 Gy in 3 fractions Group 2: tumors 2.5\~3.5 cm in diameter Dose level 1: 18 Gy in 3 fractions Dose level 2: 21 Gy in 3 fractions Dose level 3: 24 Gy in 3 fractions Three fractions will be given in one week with at least 1 day break. Concurrent bevacizumab: Bevacizumab 7.5 mg/kg will be given one day before the first fraction of radiosurgery and 2 weeks after the first dose of bevacizumab.

Radiation: Fractionated stereotactic radiosurgeryDrug: bevacizumab

Interventions

Fractionated stereotactic radiosurgeryRADIATION

Fractionated stereotactic radiosurgery: Group 1: tumors 1.5\~2.5 cm in diameter Dose level 1: 21 Gy in 3 fractions Dose level 2: 24 Gy in 3 fractions Dose level 3: 27 Gy in 3 fractions Group 2: tumors 2.5\~3.5 cm in diameter Dose level 1: 18 Gy in 3 fractions Dose level 2: 21 Gy in 3 fractions Dose level 3: 24 Gy in 3 fractions Three fractions will be given in one week with at least 1 day break.

Also known as: Fractionated SRS
Single arm dose-escalation
bevacizumabDRUG

Concurrent bevacizumab: Bevacizumab 7.5 mg/kg will be given one day before the first fraction of radiosurgery and 2 weeks after the first dose of bevacizumab.

Also known as: Avastin
Single arm dose-escalation

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with a histologic diagnosis of non-hematopoietic malignancy and radiographic evidence of measurable brain metastases (1.5\~3.5 cm).
  • The number of brain metastases receiving fractionated SRS: ≤3.
  • No evidence of leptomeningeal metastasis on gadolinium-enhanced MRI within 30 days prior registration.
  • Age ≥ 20 years.
  • Karnofsky Performance Status ≥ 60.
  • Life expectancy of ≥ 4 months.
  • Women of childbearing potential and male participants must practice adequate contraception.
  • Patients must be able to comply with the study protocol and follow-up schedules and provide study-specific informed consent.

You may not qualify if:

  • Serum creatinine \> 2.0 mg/dL within 30 days prior registration
  • Contraindication to magnetic resonance (MR) imaging such as implanted metal devices or foreign bodies, severe claustrophobia
  • Patients with evidence of bleeding diathesis or coagulopathy, international normalized ratio (INR) \>1.5
  • Patients who require the use of warfarin sodium \> 1 mg
  • Patients with active GI ulcers, GI bleeding, or active inflammatory bowel disease
  • Patients with clinically significant cardiac disease (e.g., uncontrolled hypertension \[blood pressure of \>160/90 mmHg on medication\], history of myocardial infarction or unstable angina within 12 months of registration), New York Heart Association (NYHA) Class II or greater congestive heart failure, unstable symptomatic arrhythmia requiring medication (subjects with chronic atrial arrhythmia, i.e., atrial fibrillation or paroxysmal supraventricular tachycardia) are not eligible
  • Patients with a history of aneurysms, cerebrovascular accident (CVA) and arteriovenous malformations
  • Patients with arterial thromboembolic events, including transient ischemic attack (TIA), or clinically significant peripheral artery disease within 6 months of registration
  • Patients with serious, non-healing wound, ulcer, or current healing fracture
  • Patients with a history of any type of fistula (vesicovaginal, gastrointestinal, etc) or gastrointestinal perforation
  • Severe, active comorbidities which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and adverse events of the protocol, or limit compliance with study requirements, defined as follows:
  • Uncontrolled active infection requiring intravenous antibiotics at the time of registration
  • Transmural myocardial infarction ≤ 6 months prior to registration
  • Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
  • Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

RECRUITING

MeSH Terms

Conditions

Brain Neoplasms

Interventions

Bevacizumab

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Chia-Chun Wang

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chia-Chun Wang, MD

CONTACT

chiachun@ntuh.gov.tw

Feng-Ming Hsu

CONTACT

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2016

First Posted

February 3, 2016

Study Start

January 1, 2018

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

August 18, 2017

Record last verified: 2017-08

Locations

TW(1)