Improving Therapeutic Ratio With Hypo Fractionated Stereotactic Radiotherapy for Brain Metastases (SAFESTEREO)

Haaglanden Medical Centre

Status: Enrolling

Conditions: Brain Metastases

Treatments: Radiation: SRT; Radiation: fSRT

Study type: Interventional

Funder types: Other

Identifiers

NCT05346367

2021-115LR

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 130 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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130 participants in 2 patient groups

SRT (stereotactic radiotherapy)

Active Comparator group

Description:

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

Treatment:

Radiation: SRT

fSRT (hypo fractionated stereotactic radiotherapy)

Experimental group

Description:

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

Treatment:

Radiation: fSRT