Improving Therapeutic Ratio With Hypo Fractionated Stereotactic Radiotherapy for Brain Metastases

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHaaglanden Medical Centre

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • SRT

    Radiation

    SRT

  • fSRT

    Radiation

    fSRT

Treatment groups

130 Participants
are divided into 2 treatment groups
Group A: SRT (stereotactic radiotherapy)Active comparator 1 intervention
Group B: fSRT (hypo fractionated stereotactic radiotherapy)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

radio necrosis or local failure

Incidence of either radio necrosis or local failure according to Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM).

Time frame
2 years after treatment

Secondary outcomes

1

Survival

median survival with Kaplan Meyer analysis

Time frame
2 years after treatment
2

symptomatic radio necrosis (RN) or local failure (LF)

incidence of RN or LF within 2 years after SRT

Time frame
2 years after treatment
3

salvage treatment

incidence of salvage treatment within 2 years after SRT

Time frame
2 years after treatment
4

distant brain recurrences

incidence of distant brain recurrences within 2 years after SRT

Time frame
2 years after treatment

Other outcomes

Sponsors and contacts

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