Improving Therapeutic Ratio With Hypo Fractionated Stereotactic Radiotherapy for Brain Metastases

Study Purpose

Randomized phase II trial. The study aims to investigate a different and potentially safer radio therapeutic treatment method for brain metastases. The current standard of stereotactic radiotherapy (SRT) in one or three fractions is compared to fractionated stereotactic radiotherapy (fSRT) in five fractions.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Age ≥ 18 years.
  • - At least one brain metastasis of large cell cancer suitable for SRT.
  • - Karnofsky Performance Status ≥ 70.
  • - Ability to provide written informed consent.
  • - New brain metastases during follow-up after surgery allowed (when outside of resection cavity area) - New brain metastases during follow-up after previous SRT allowed (when outside of previous irradiation field)

    Exclusion Criteria:

    - Contra-indication for MRI scan.
  • - Primary tumor of small cell lung cancer, germinoma or lymphoma.
  • - Prior whole brain radiotherapy or SRT on the current target brain metastases (in field re-irradiation) - Presence of leptomeningeal metastases.
- Previous inclusion in the SAFESTEREO study

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05346367
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Haaglanden Medical Centre
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Jaap D Zindler, MD, PhD
Principal Investigator Affiliation Haaglanden MC
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries Netherlands
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Brain Metastases
Additional Details

Randomized phase II trial. Stereotactic radiotherapy is one of the most frequently chosen treatment options for brain metastases. There are an increasing number of long term survivors. Brain necrosis (e.g. radio necrosis) is the most important long term side effect of the treatment, occurring in up to 40% of patients, dependent on the size of the metastasis and delivered radiotherapy dose. Retrospective studies have shown that the incidence of radio necrosis, as well as local tumor recurrence, can be decreased with a risk difference of around 20% by administrating fractionated stereotactic radiotherapy (fSRT, e.g. five fractions) over single fraction stereotactic radiotherapy, especially in large brain metastases. In this trial, one group is treated with SRT in one or three fractions. The other group is treated with fSRT in five fractions. Survival, toxicity and patient reported quality of life are monitored.

Arms & Interventions

Arms

Active Comparator: SRT (stereotactic radiotherapy)

stereotactic radiotherapy in 1 or 3 fractions of 8 Gy up to 15-24 Gy

Experimental: fSRT (hypo fractionated stereotactic radiotherapy)

hypo fractionated stereotactic radiotherapy in 5 fractions of 7 Gy up to 35 Gy. Brain stem metastases 5 fractions of 6 Gy up to 30 Gy

Interventions

Radiation: - SRT

SRT

Radiation: - fSRT

fSRT

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Haaglanden Medisch Centrum, Leidschendam, Zuid-Holland, Netherlands

Status

Recruiting

Address

Haaglanden Medisch Centrum

Leidschendam, Zuid-Holland, 2262 BA

Site Contact

Jaap Zindler, Dr

[email protected]

+31-88-9792013

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