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

NCT03697343 | Recruiting Phase 3 DMC

• 1 other identifier: FSRT-Trial
• Study Type: interventional
• Target: 382
• Locations: 1 country
• Sites: 13

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)

Conditions

Cerebral Metastases of Solid Cancers

Outcome Measures

Primary Outcomes (1)

• 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.

  12 months

Secondary Outcomes (6)

• CNS toxicity according to CTCAE v5.0

  12 months

• Time to local progression (Volumetric RANO-BM criteria)

  12 months

• Quality of Life according to EORTC QLQ-C30

  Change from baseline to 3, 6, 12 and 24 months

• Local-Progression-Free Survival

  12 months

• Overall Survival

  24 months

Study Arms (2)

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

OTHER

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

Radiation: Radiosurgery

Fractionated stereotactic radiotherapy with 12 x 4 Gy and 2 mm

OTHER

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

Radiation: Fractionated stereotactic radiotherapy

Interventions

Radiosurgery RADIATION

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

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

Fractionated stereotactic radiotherapy RADIATION

Fractionated stereotactic radiotherapy with 12 x 4 Gy and 2 mm

Fractionated stereotactic radiotherapy with 12 x 4 Gy and 2 mm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Erlangen-Nürnberg Medical School: lead

Study Sites (13)

Klinik für Strahlentherapie und Radioonkologie Stuttgart

Stuttgart, Baden-Wurttemberg, 70174, Germany

RECRUITING

Klinik für Strahlentherapie Bayreuth

Bayreuth, Bavaria, 95445, Germany

RECRUITING

Strahlentherapie Coburg

Coburg, Bavaria, 96450, Germany

RECRUITING

Radio-Log Strahlentherapie Hof

Hof, Bavaria, 95032, Germany

RECRUITING

Strahlentherapie Süd Kempten

Kempten (Allgäu), Bavaria, 87439, Germany

RECRUITING

Klinik und Poliklinik für RadioOnkologie und Strahlentherapie München (TUM)

München, Bavaria, 81675, Germany

RECRUITING

Klinik und Poliklinik für Strahlentherapie Regensburg

Regensburg, Bavaria, 93053, Germany

RECRUITING

Klinik für Strahlentherapie und Radioonkologie

Bonn, North Rhine-Westphalia, 53127, Germany

RECRUITING

Klink und Praxis für Radioonkologie Chemnitz

Chemnitz, Saxony, 09113, Germany

RECRUITING

Universitätsklinik und Poliklinik für Strahlentherapie Halle

Halle, Saxony-Anhalt, 06120, Germany

RECRUITING

Klinik für Strahlentherapie und Radioonkologie Universitätsklinikum Jena

Jena, Thuringia, 07745, Germany

RECRUITING

Klinik für Radioonkologie und Strahlentherapie Charité Berlin

Berlin, 13353, Germany

RECRUITING

Erlangen, Universitätsklinikum Strahlenklinik

Erlangen, 91054, Germany

RECRUITING

MeSH Terms

Interventions

Radiosurgery

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Rainer Fietkau, Prof.

  Universitätsklinikum Erlangen, Strahlenklinik

  PRINCIPAL INVESTIGATOR

• Florian Putz, PD Dr.med.

  Universitätsklinikum Erlangen, Strahlenklinik

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Florian Putz, PD Dr. med.

CONTACT

++49(0)9131-85-33405; florian.putz@uk-erlangen.de

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, multicenter, Open-Label, randomized

Study Record Dates

• First Submitted: September 26, 2018
• First Posted: October 5, 2018
• Study Start: May 18, 2021
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: December 13, 2022

Record last verified: 2022-12

Locations

DE (13)