SAFESTEREO: Improving Therapeutic Ratio With Hypofractionated Stereotactic Radiotherapy for Brain Metastases

Sponsor
Haaglanden Medical Centre (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05346367
Collaborator
(none)
130
2
58

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Radiation: SRT
  • Radiation: fSRT
N/A

Detailed 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. radionecrosis) 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 radionecrosis, 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
130 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
1:1 randomization1:1 randomization
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Improving Therapeutic Ratio With Hypofractionated Stereotactic Radiotherapy for Brain Metastases
Anticipated Study Start Date :
May 1, 2022
Anticipated Primary Completion Date :
Mar 1, 2027
Anticipated Study Completion Date :
Mar 1, 2027

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: SRT (stereotactic radiotherapy)

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

Radiation: SRT
SRT

Experimental: fSRT (hypofractionated stereotactic radiotherapy)

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

Radiation: fSRT
fSRT

Outcome Measures

Primary Outcome Measures

  1. radionecrosis or local failure [2 years after treatment]

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

Secondary Outcome Measures

  1. Survival [2 years after treatment]

    median survival with Kaplan Meyer analysis

  2. symptomatic radionecrosis (RN) or local failure (LF) [2 years after treatment]

    incidence of RN or LF within 2 years after SRT

  3. salvage treatment [2 years after treatment]

    incidence of salvage treatment within 2 years after SRT

  4. distant brain recurrences [2 years after treatment]

    incidence of distant brain recurrences within 2 years after SRT

  5. Dose dexamethasone [baseline - 2 years after treatment]

    Dose dexamethasone in mg per day

  6. Anti-epileptic drug use [baseline - 2 years after treatment]

    Anti-epileptic drug use in mg per day

  7. Grade 2 or more toxicity (CTCAE v5.0) [baseline - 2 years after treatment]

    incidence of Grade 2 or more toxicity according to CTCAE version 5.0 within 2 years after SRT

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Age ≥ 18 years

  • At least one brain metastasis of large cell cancer suitable for SRT

  • Ability to provide written informed consent-

Exclusion Criteria:
  • Contra-indication for MRI scan

  • Primary tumor of small cell lung cancer, germinoma or lymphoma

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Haaglanden Medical Centre

Investigators

  • Principal Investigator: Jaap D Zindler, MD, PhD, Haaglanden MC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jaap Zindler, Principal Investigator, MD, PhD, radiation oncologist, Haaglanden Medical Centre
ClinicalTrials.gov Identifier:
NCT05346367
Other Study ID Numbers:
  • 2021-115LR
First Posted:
Apr 26, 2022
Last Update Posted:
Apr 26, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Jaap Zindler, Principal Investigator, MD, PhD, radiation oncologist, Haaglanden Medical Centre
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 26, 2022