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

Primary Purpose

Brain Metastases

Status
Recruiting
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
SRT
fSRT
Sponsored by
Haaglanden Medical Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain Metastases focused on measuring fractionated stereotactic radiotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Haaglanden Medisch CentrumRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

SRT (stereotactic radiotherapy)

fSRT (hypo fractionated stereotactic radiotherapy)

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Survival
median survival with Kaplan Meyer analysis
symptomatic radio necrosis (RN) or local failure (LF)
incidence of RN or LF within 2 years after SRT
salvage treatment
incidence of salvage treatment within 2 years after SRT
distant brain recurrences
incidence of distant brain recurrences within 2 years after SRT
Dose dexamethasone
Dose dexamethasone in mg per day
Anti-epileptic drug use
Anti-epileptic drug use in mg per day
Grade 2 or more toxicity (CTCAE v5.0)
incidence of Grade 2 or more toxicity according to CTCAE version 5.0 within 2 years after SRT

Full Information

First Posted
April 13, 2022
Last Updated
September 7, 2022
Sponsor
Haaglanden Medical Centre
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1. Study Identification

Unique Protocol Identification Number
NCT05346367
Brief Title
Improving Therapeutic Ratio With Hypo Fractionated Stereotactic Radiotherapy for Brain Metastases
Acronym
SAFESTEREO
Official Title
Improving Therapeutic Ratio With Hypo Fractionated Stereotactic Radiotherapy for Brain Metastases
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 18, 2022 (Actual)
Primary Completion Date
March 2027 (Anticipated)
Study Completion Date
March 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Haaglanden Medical Centre

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Metastases
Keywords
fractionated stereotactic radiotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
1:1 randomization
Masking
None (Open Label)
Allocation
Randomized
Enrollment
130 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SRT (stereotactic radiotherapy)
Arm Type
Active Comparator
Arm Description
stereotactic radiotherapy in 1 or 3 fractions of 8 Gy up to 15-24 Gy
Arm Title
fSRT (hypo fractionated stereotactic radiotherapy)
Arm Type
Experimental
Arm 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
Intervention Type
Radiation
Intervention Name(s)
SRT
Intervention Description
SRT
Intervention Type
Radiation
Intervention Name(s)
fSRT
Intervention Description
fSRT
Primary Outcome Measure Information:
Title
radio necrosis or local failure
Description
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 Outcome Measure Information:
Title
Survival
Description
median survival with Kaplan Meyer analysis
Time Frame
2 years after treatment
Title
symptomatic radio necrosis (RN) or local failure (LF)
Description
incidence of RN or LF within 2 years after SRT
Time Frame
2 years after treatment
Title
salvage treatment
Description
incidence of salvage treatment within 2 years after SRT
Time Frame
2 years after treatment
Title
distant brain recurrences
Description
incidence of distant brain recurrences within 2 years after SRT
Time Frame
2 years after treatment
Title
Dose dexamethasone
Description
Dose dexamethasone in mg per day
Time Frame
baseline - 2 years after treatment
Title
Anti-epileptic drug use
Description
Anti-epileptic drug use in mg per day
Time Frame
baseline - 2 years after treatment
Title
Grade 2 or more toxicity (CTCAE v5.0)
Description
incidence of Grade 2 or more toxicity according to CTCAE version 5.0 within 2 years after SRT
Time Frame
baseline - 2 years after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jaap D Zindler, MD, PhD
Phone
+31-88-9792013
Email
j.zindler@haaglandenmc.nl
First Name & Middle Initial & Last Name or Official Title & Degree
Mirjam Mast, PhD
Phone
+31-88-9792013
Email
m.mast@haaglandenmc.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jaap D Zindler, MD, PhD
Organizational Affiliation
Haaglanden MC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Haaglanden Medisch Centrum
City
Leidschendam
State/Province
Zuid-Holland
ZIP/Postal Code
2262 BA
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jaap Zindler, Dr
Email
j.zindler@haaglandenmc.nl
First Name & Middle Initial & Last Name & Degree
Ursula Fisscher, PhD
Email
u.fisscher@haaglandenmc.nl

12. IPD Sharing Statement

Plan to Share IPD
No

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Improving Therapeutic Ratio With Hypo Fractionated Stereotactic Radiotherapy for Brain Metastases

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