NCT03027544

Brief Summary

This clinical trial was designed to investigate the efficiency and toxicity of tomotherapy for refractory brain metastases.

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
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2014

Longer than P75 for not_applicable

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

Study Start

First participant enrolled

September 1, 2014

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

January 19, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 23, 2017

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
Last Updated

January 23, 2017

Status Verified

January 1, 2017

Enrollment Period

4 years

First QC Date

January 19, 2017

Last Update Submit

January 19, 2017

Conditions

Brain Metastases

Keywords

multiple brain metastaseslarge brain metastasesmeningeal metastasestomotherapy

Outcome Measures

Primary Outcomes (1)

  • Objective response rate

    Using RTOG9508 criteria, Tumor control is defined as CR+PR+SD

    2-3 months after radiation

Secondary Outcomes (6)

  • Overall survival rate

    up to 3 years

  • progress free survival rate

    up to 1 year

  • local control rate

    up to 1 year

  • intracranial progress free survival rate

    up to 1 year

  • adverse event

    from the day of radiation, up to 6 months

  • +1 more secondary outcomes

Study Arms (1)

experimental arm

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. Intervention：tomotherapy

Radiation: tomotherapy

Interventions

tomotherapyRADIATION

Tomotherapy: 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; 3. multiple lesions with large lesion: whole brain radiation (WBRT) with 40Gy/2Gy/20f and concurrent boost of 60Gy/3Gy/20f of the lesions. TMZ is used if necessary: concomitant TMZ: 75mg/m2 adjuvant TMZ: 150mg/ m2\*5d, q28d, up to 6cycles.

experimental arm

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

RECRUITING

MeSH Terms

Conditions

Brain NeoplasmsMeningeal Carcinomatosis

Interventions

Radiotherapy, Intensity-Modulated

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Radiotherapy, ConformalRadiotherapy, Computer-AssistedRadiotherapyTherapeutics

Study Officials

  • Jianping Xiao

    Chinese Academy of Medical Sciences

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jianping Xiao

CONTACT

86-13811026919jpxiao8@163.com

Study Design

Study Type
interventional
Phase
not applicable
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 19, 2017

First Posted

January 23, 2017

Study Start

September 1, 2014

Primary Completion

September 1, 2018

Study Completion

September 1, 2018

Last Updated

January 23, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share

the baseline characteristics and treatment plan can be shared with other researchers when the research paper has been published. The IPD will be sent by email if applied.

Locations

CN(1)