AzTrials
AzTrials

Brain MetastasesPhase 2SRTRBMNCT02654106

Stereotactic Radiotherapy Plus Temozolomide for Refractory Brain Metastases

A Phase 2 study testing Fractionated Stereotactic Radiotherapy and Temozolomide in people with Brain Metastases, run by Chinese Academy of Medical Sciences at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Brain Metastases
What is being tested?
Fractionated Stereotactic Radiotherapy and Temozolomide
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
65 participants
Where
1 siteChina
Study dates
Oct 2011to Nov 2015
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality, 100021

Other trials in China

About this study

Official title: Fractionated Stereotactic Radiotherapy Combined With Temozolomide for Refractory Brain Metastases: A Single-arm, Single-center Phase II Trial

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

Read the detailed description

This is a single-arm, single center, phase II trial to investigate the feasibility and toxicity of FSRT plus TMZ for refractory brain metastases, which are defined as A: multiple brain metastases(≥3 lesions); B: large brain metastases(with one lesion's volume is no smaller than 6cc or the longest diameter is no shorter than 3cm); C: meningeal metastases.

Being tested
Fractionated Stereotactic Radiotherapy, Temozolomide
Keywords
multiple brain metastases, large brain metastases, meningeal metastases, fractionated stereotactic radiotherapy, temozolomide
Medical subject headings
Brain Neoplasms, Meningeal Carcinomatosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Fractionated Stereotactic RadiotherapyRadiation

    Also called FSRT

    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.

  • TemozolomideDrug

    Also called TMZ

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

Study groups in NCT02654106
Study groupRoleWhat they receive
Refractory Brain MetastasesExperimentalGroup 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
Receives: Radiation: Fractionated Stereotactic Radiotherapy; Drug: Temozolomide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. intracranial progress free survival rate

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

    Measured: up to 2 years

Secondary outcomes (6)

  1. Overall survival rate

    Measured: up to 3 year

  2. progress free survival rate

    Measured: up to 1 year

  3. local control rate

    Measured: up to 1 year

  4. disease control rate (DCR)

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

    Measured: 2-3 months after radiation

  5. adverse event

    assessed by CTCAE criteria, v4.0 and RTOG criteria of the central nervous system

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

  6. causes of death

    collect the data of causes of death and analyze

    Measured: from the day of radiation to death date, up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jan 2016 (estimated)
  2. Study startOct 2011
  3. Primary completionNov 2015
  4. Study completionNov 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
65 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02654106
Sponsor's protocol ID
CH-H&N-003
Acronym
SRTRBM
Status last verified
Jun 2017
First submitted
10 Jan 2016
Last updated
6 Jun 2017
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 30996008

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Fractionated Stereotactic Radiotherapy and Temozolomide in people with Brain Metastases, run by Chinese Academy of Medical Sciences at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

intracranial progress free survival rate (time frame: up to 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02654106, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2017.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in