NCT02654106

Brief Summary

This clinical trial was designed to investigate the efficiency and toxicity of fractionated stereotactic radiotherapy(FSRT) combined with Temozolomide(TMZ) for refractory brain metastases.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
65

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Oct 2011

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

October 1, 2011

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 10, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 13, 2016

Completed
Last Updated

June 6, 2017

Status Verified

June 1, 2017

Enrollment Period

4.1 years

First QC Date

January 10, 2016

Last Update Submit

June 5, 2017

Conditions

Brain Metastases

Keywords

multiple brain metastaseslarge brain metastasesmeningeal metastasesfractionated stereotactic radiotherapytemozolomide

Outcome Measures

Primary Outcomes (1)

  • intracranial progress free survival rate

    defined as no progress of the treated lesions and no distant progress in the brain

    up to 2 years

Secondary Outcomes (6)

  • Overall survival rate

    up to 3 year

  • progress free survival rate

    up to 1 year

  • local control rate

    up to 1 year

  • disease control rate (DCR)

    2-3 months after radiation

  • adverse event

    from the day of radiation to the end of adjuvant TMZ，up to 6 months

  • +1 more secondary outcomes

Study Arms (1)

Refractory Brain Metastases

EXPERIMENTAL

Group A: multiple brain metastases: no less than 3 lesions in the brain Group B: Large Brain Metastases: the volume of lesion is no smaller than 6cc or the maximum diameter of the lesion is no shorter than 3cm Group C:Meningeal Metastases

Radiation: Fractionated Stereotactic RadiotherapyDrug: Temozolomide

Interventions

Fractionated Stereotactic RadiotherapyRADIATION

The regular fraction modes were as follows: a. lesions≥3 cm：52Gy/4Gy/13f or 52.5Gy/3.5Gy/15f; b. lesions\<2cm：36Gy/12Gy/3f or 24Gy/24Gy/1f; for lesions located in function areas, it would be adjusted to 40Gy/8Gy/5f; c. lesions 2-3cm：40-48Gy/8-10Gy/6-4f; d. lesions located in brainstem：50-60Gy/2.5-3Gy/20f.

Also known as: FSRT
Refractory Brain Metastases
TemozolomideDRUG

concomitant TMZ: 75mg/m2 adjuvant TMZ: 150mg/m2\*5d, q28d, 6cycles

Also known as: TMZ
Refractory Brain Metastases

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologic or cytologic diagnosis of primary tumor and conformed brain metastases by enhanced MRI or CT
  • the lesion number is no less than 3; or the tumor volume is no smaller than 6cc; or tumor diameter is no shorter than 3cm; or uncontrolled brain tumor after whole brain radiotherapy(WBRT); or the tumor is adjacent to essential structures of the brain, such as brain stem, optic chiasma, optic tract, etc.
  • KPS ≥60，or KPS ≥40 and the limitation of motion is simply caused by brain tumor that is adjacent to the motor function areas.
  • Age: 18-75 years old.
  • Adequate end-organ function:
  • WBC≥4.0x109/L Neu ≥ 1.5x109/L Hemoglobin ≥ 110 g/L Platelets ≥100 x109/L Total bilirubin ≤ 1.5x ULN AST and ALT ≤ 1.5x ULN BUN and Cr: within the normal range

You may not qualify if:

  • Other clinically significant diseases (e.g.myocardial infarction within the past 6 months, severe arrhythmia).
  • Unable or unwilling to comply with the study protocol.
  • The expected survival time is less than 3 months.
  • Patients who are anticipated in other clinical trials of brain metastases.
  • Patients who has been treated with SRT in other hospitals
  • Pregnant patients or female patients whose HCG is positive
  • Unsuitable to participate in study, that in the opinion of the treating physician.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

Location

Related Publications (1)

  • Bi N, Ma Y, Xiao J, Zhang H, Xu Y, Tian Y, Li J, Zhang Y, Liu Q, Wang K, Deng L, Wang W, Chen X, Liu F, Zhao R, Yang S, Huang X, Yi J, Hu C, Li Y. A Phase II Trial of Concurrent Temozolomide and Hypofractionated Stereotactic Radiotherapy for Complex Brain Metastases. Oncologist. 2019 Sep;24(9):e914-e920. doi: 10.1634/theoncologist.2018-0702. Epub 2019 Apr 17.

    PMID: 30996008DERIVED

MeSH Terms

Conditions

Brain NeoplasmsMeningeal Carcinomatosis

Interventions

Temozolomide

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMeningeal Neoplasms

Intervention Hierarchy (Ancestors)

DacarbazineTriazenesOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Jianping Xiao

    Chinese Academy of Medical Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

January 10, 2016

First Posted

January 13, 2016

Study Start

October 1, 2011

Primary Completion

November 1, 2015

Study Completion

November 1, 2015

Last Updated

June 6, 2017

Record last verified: 2017-06

Locations

CN(1)