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Fractionated Stereotactic Radiotherapy vs. Single Session Radiosurgery in Patients With Larger Brain Metastases

Primary Purpose

Cerebral Metastases of Solid Cancers

Status
Recruiting
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Radiosurgery
Fractionated stereotactic radiotherapy
Sponsored by
University of Erlangen-Nürnberg Medical School
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Metastases of Solid Cancers

Eligibility Criteria

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

Inclusion Criteria:

  • Age > 18 years, no upper age limit
  • Karnofsky Performance Score > 50 points
  • Expected Survival > 3 months
  • 1-4 cerebral metastases of metastatic solid cancer
  • Indication for local radiotherapy
  • Patients must be able to understand the protocol and provide informed consent

Exclusion Criteria:

  • Whole Brain radiotherapy no longer than 6 weeks before the start of stereotactic radiotherapy or planned whole brain radiotherapy after stereotactic radiotherapy
  • Prior irradiation of the cerebral metastasis that is to be treated in the study
  • Relevant overlap of prior radiation fields with the metastasis that is to be treated in the study
  • Metastasis in the brainstem
  • More than 6 cerebral metastases including the patient's prior history
  • Contraindication for cerebral MRI
  • Metastasis that is to be treated in the study can't be visualized in contrast-enhanced T1 MRI sequence
  • Pregnant or lactating women
  • Abuse of illicit drugs, alcohol or medication
  • Patient not able or willing to behave according to protocol
  • Participation in another clinical trial

Sites / Locations

  • Klinik für Strahlentherapie und Radioonkologie StuttgartRecruiting
  • Klinik für Strahlentherapie BayreuthRecruiting
  • Strahlentherapie CoburgRecruiting
  • Radio-Log Strahlentherapie HofRecruiting
  • Strahlentherapie Süd KemptenRecruiting
  • Klinik und Poliklinik für RadioOnkologie und Strahlentherapie München (TUM)Recruiting
  • Klinik und Poliklinik für Strahlentherapie RegensburgRecruiting
  • Klinik für Strahlentherapie und RadioonkologieRecruiting
  • Universitätsklinik und Poliklinik für Strahlentherapie HalleRecruiting
  • Klink und Praxis für Radioonkologie ChemnitzRecruiting
  • Klinik für Strahlentherapie und Radioonkologie Universitätsklinikum JenaRecruiting
  • Klinik für Radioonkologie und Strahlentherapie Charité BerlinRecruiting
  • Erlangen, Universitätsklinikum StrahlenklinikRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Radiosurgery with 1 x 18 Gy (2-3 cm) or 1 x 15 Gy (3-4 cm) and

Fractionated stereotactic radiotherapy with 12 x 4 Gy and 2 mm

Arm Description

Radiosurgery with 1 x 18 Gy (2-3 cm) or 1 x 15 Gy (3-4 cm) and no margin as defined by the RTOG 9005

Fractionated stereotactic radiotherapy with 12 x 4 Gy and 2 mm margin

Outcomes

Primary Outcome Measures

Time to local progression - TTLP
Local progression will be defined according to the RANO-BM criteria by an increase of at least 20% in the longest diameter of the metastasis relative to nadir or baseline. In addition to the relative increase of 20% the lesion must increase by an absolute value of 5 mm or more. TTLP is defined as the time from randomization until the detection of progression as per the RANO-BM criteria. Patients will be censored if they have no signs of local progression at the time of last tumor monitoring during follow-up or at the onset of one of the following competing risk events not associated with local progression: death, lost to follow up, unauthorized non-protocol treatment of the target lesion. Confirmatory analysis of the primary endpoint variable will be performed using a p-value of p≤0.05 as the global significance level.

Secondary Outcome Measures

CNS toxicity according to CTCAE v5.0
CNS toxicity according to CTCAE v5.0
Time to local progression (Volumetric RANO-BM criteria)
Based on the RANO-BM criteria, progression is defined as an increase in volume of 72.8% or more (corresponds to a 20% increase in diameter for a perfect sphere).
Quality of Life according to EORTC QLQ-C30
Quality of life measured by European Organization for Research and Treatment of Cancer (EORTC) questionnaire QLQ C30
Local-Progression-Free Survival
Local-Progression-Free Survival is defined like TTLP except that death not associated with local progression will not be censored but assessed as a separate event
Overall Survival
Overall Survival
Quality of Life according to EORTC QLQ-BN20
Quality of life measured by European Organization for Research and Treatment of Cancer (EORTC) questionnaire QLQ BN20

Full Information

First Posted
September 26, 2018
Last Updated
December 9, 2022
Sponsor
University of Erlangen-Nürnberg Medical School
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1. Study Identification

Unique Protocol Identification Number
NCT03697343
Brief Title
Fractionated Stereotactic Radiotherapy vs. Single Session Radiosurgery in Patients With Larger Brain Metastases
Official Title
Efficacy and Safety of Fractionated Stereotactic Radiotherapy (FSRT) in Comparison to Single Session Radiosurgery in Patients With Larger Brain Metastases (2-4 cm)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 18, 2021 (Actual)
Primary Completion Date
May 2026 (Anticipated)
Study Completion Date
May 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Erlangen-Nürnberg Medical School

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
Phase III trial comparing local control and side effects after fractionated stereotactic radiotherapy and single session radiosurgery in patients with larger brain metastases (2-4 cm)
Detailed Description
This is a prospective, multicenter randomized trial comparing local control and side effects after fractionated stereotactic radiotherapy with 12 x 4 Gy and single session radiosurgery according to RTOG 9005 in patients with larger brain metastases (2-4 cm). Patients will be randomized to either fractionated stereotactic radiotherapy with 12 x 4 Gy or radiosurgery with 1 x 18 Gy (2-3 cm) or 1 x 15 Gy (3-4 cm) as defined by the RTOG 9005. Randomization will be stratified by metastasis volume and histology.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Metastases of Solid Cancers

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Prospective, multicenter, Open-Label, randomized
Masking
None (Open Label)
Allocation
Randomized
Enrollment
382 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Radiosurgery with 1 x 18 Gy (2-3 cm) or 1 x 15 Gy (3-4 cm) and
Arm Type
Other
Arm Description
Radiosurgery with 1 x 18 Gy (2-3 cm) or 1 x 15 Gy (3-4 cm) and no margin as defined by the RTOG 9005
Arm Title
Fractionated stereotactic radiotherapy with 12 x 4 Gy and 2 mm
Arm Type
Other
Arm Description
Fractionated stereotactic radiotherapy with 12 x 4 Gy and 2 mm margin
Intervention Type
Radiation
Intervention Name(s)
Radiosurgery
Intervention Description
Radiosurgery with 1 x 18 Gy (2-3 cm) or 1 x 15 Gy (3-4 cm)
Intervention Type
Radiation
Intervention Name(s)
Fractionated stereotactic radiotherapy
Intervention Description
Fractionated stereotactic radiotherapy with 12 x 4 Gy and 2 mm
Primary Outcome Measure Information:
Title
Time to local progression - TTLP
Description
Local progression will be defined according to the RANO-BM criteria by an increase of at least 20% in the longest diameter of the metastasis relative to nadir or baseline. In addition to the relative increase of 20% the lesion must increase by an absolute value of 5 mm or more. TTLP is defined as the time from randomization until the detection of progression as per the RANO-BM criteria. Patients will be censored if they have no signs of local progression at the time of last tumor monitoring during follow-up or at the onset of one of the following competing risk events not associated with local progression: death, lost to follow up, unauthorized non-protocol treatment of the target lesion. Confirmatory analysis of the primary endpoint variable will be performed using a p-value of p≤0.05 as the global significance level.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
CNS toxicity according to CTCAE v5.0
Description
CNS toxicity according to CTCAE v5.0
Time Frame
12 months
Title
Time to local progression (Volumetric RANO-BM criteria)
Description
Based on the RANO-BM criteria, progression is defined as an increase in volume of 72.8% or more (corresponds to a 20% increase in diameter for a perfect sphere).
Time Frame
12 months
Title
Quality of Life according to EORTC QLQ-C30
Description
Quality of life measured by European Organization for Research and Treatment of Cancer (EORTC) questionnaire QLQ C30
Time Frame
Change from baseline to 3, 6, 12 and 24 months
Title
Local-Progression-Free Survival
Description
Local-Progression-Free Survival is defined like TTLP except that death not associated with local progression will not be censored but assessed as a separate event
Time Frame
12 months
Title
Overall Survival
Description
Overall Survival
Time Frame
24 months
Title
Quality of Life according to EORTC QLQ-BN20
Description
Quality of life measured by European Organization for Research and Treatment of Cancer (EORTC) questionnaire QLQ BN20
Time Frame
Change from baseline to 3, 6, 12 and 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age > 18 years, no upper age limit Karnofsky Performance Score > 50 points Expected Survival > 3 months 1-10 cerebral metastases of metastatic solid cancer Indication for local radiotherapy Patients must be able to understand the protocol and provide informed consent Exclusion Criteria: Whole Brain radiotherapy no longer than 6 weeks before the start of stereotactic radiotherapy or planned whole brain radiotherapy after stereotactic radiotherapy Prior irradiation of the cerebral metastasis that is to be treated in the study Relevant overlap of prior radiation fields with the metastasis that is to be treated in the study Metastasis in the brainstem Contraindication for cerebral MRI Metastasis that is to be treated in the study can't be visualized in contrast-enhanced T1 MRI sequence Pregnant or lactating women Abuse of illicit drugs, alcohol or medication Patient not able or willing to behave according to protocol Participation in another clinical trial
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Florian Putz, PD Dr. med.
Phone
++49(0)9131-85-33405
Email
florian.putz@uk-erlangen.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rainer Fietkau, Prof.
Organizational Affiliation
Universitätsklinikum Erlangen, Strahlenklinik
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Florian Putz, PD Dr.med.
Organizational Affiliation
Universitätsklinikum Erlangen, Strahlenklinik
Official's Role
Principal Investigator
Facility Information:
Facility Name
Klinik für Strahlentherapie und Radioonkologie Stuttgart
City
Stuttgart
State/Province
Baden-Württemberg
ZIP/Postal Code
70174
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marc Münter, Prof. Dr.
Phone
0711 278-34201
Email
k.stahl@klinikum-stuttgart.de
Facility Name
Klinik für Strahlentherapie Bayreuth
City
Bayreuth
State/Province
Bayern
ZIP/Postal Code
95445
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ludwig Keilholz, Prof. Dr.
Phone
0921 400-6802
Facility Name
Strahlentherapie Coburg
City
Coburg
State/Province
Bayern
ZIP/Postal Code
96450
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gerhard Grabenbauer, Prof. Dr.
Phone
09561 2491-0
Email
strahlentherapie@diacura.de
Facility Name
Radio-Log Strahlentherapie Hof
City
Hof
State/Province
Bayern
ZIP/Postal Code
95032
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christoph Straube, PD Dr.
Phone
09281-140369 0
Email
strahlentherapie-hof@radio-log.de
Facility Name
Strahlentherapie Süd Kempten
City
Kempten
State/Province
Bayern
ZIP/Postal Code
87439
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sterzing, Prof. Dr.
Phone
+49(0)831 9607940
Email
info@strahlentherapie-kempten.de
Facility Name
Klinik und Poliklinik für RadioOnkologie und Strahlentherapie München (TUM)
City
München
State/Province
Bayern
ZIP/Postal Code
81675
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Denise Bernhardt, PD Dr.
Phone
+49 89 4140 4501
Facility Name
Klinik und Poliklinik für Strahlentherapie Regensburg
City
Regensburg
State/Province
Bayern
ZIP/Postal Code
93053
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Oliver Kölbl, Prof. Dr.
Facility Name
Klinik für Strahlentherapie und Radioonkologie
City
Bonn
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
53127
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christopher Schmeel, PD Dr.
Phone
+49 228 287-10354
Email
Anmeldung.Strahlentherapie@ukbonn.de
Facility Name
Universitätsklinik und Poliklinik für Strahlentherapie Halle
City
Halle
State/Province
Sachsen-Anhalt
ZIP/Postal Code
06120
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christian Dietzel, Dr. med.
Phone
0345 557 4310
Email
Strahlentherapie@uk-halle.de
Facility Name
Klink und Praxis für Radioonkologie Chemnitz
City
Chemnitz
State/Province
Sachsen
ZIP/Postal Code
09113
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gunther Klautke, PD Dr. med.
Facility Name
Klinik für Strahlentherapie und Radioonkologie Universitätsklinikum Jena
City
Jena
State/Province
Thüringen
ZIP/Postal Code
07745
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrea Wittig, Prof. Dr.
Phone
03641/9-328401
Email
strahlentherapie@med.uni-jena.de
Facility Name
Klinik für Radioonkologie und Strahlentherapie Charité Berlin
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Felix Ehret, Dr. med.
Phone
+49 30 450 527 152
Email
melita.dimitrijevic@charite.de
Facility Name
Erlangen, Universitätsklinikum Strahlenklinik
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rainer Fietkau, Prof.
Phone
+499131-85-33405
Email
rainer.fietkau@uk-erlangen.de

12. IPD Sharing Statement

Learn more about this trial

Fractionated Stereotactic Radiotherapy vs. Single Session Radiosurgery in Patients With Larger Brain Metastases

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