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

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ClinicalTrials.gov Identifier: NCT03697343
Recruitment Status : Not yet recruiting
First Posted : October 5, 2018
Last Update Posted : October 9, 2018
Sponsor:
Information provided by (Responsible Party):
University of Erlangen-Nürnberg Medical School

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)

Condition or disease Intervention/treatment Phase
Cerebral Metastases of Solid Cancers Radiation: Radiosurgery Radiation: Fractionated stereotactic radiotherapy Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 302 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective, multicenter, Open-Label, randomized
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Estimated Study Start Date : January 2019
Estimated Primary Completion Date : January 2024
Estimated Study Completion Date : January 2024

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

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




Primary Outcome Measures :
  1. Time to local progression - TTLP [ Time Frame: 12 months ]

    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 :
  1. CNS toxicity according to CTCAE v5.0 [ Time Frame: 12 months ]
    CNS toxicity according to CTCAE v5.0

  2. Time to local progression (Volumetric RANO-BM criteria) [ Time Frame: 12 months ]
    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).

  3. Quality of Life according to EORTC QLQ-C30 [ Time Frame: Change from baseline to 3, 6, 12 and 24 months ]
    Quality of life measured by European Organization for Research and Treatment of Cancer (EORTC) questionnaire QLQ C30

  4. Local-Progression-Free Survival [ Time Frame: 12 months ]
    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

  5. Overall Survival [ Time Frame: 24 months ]
    Overall Survival

  6. Quality of Life according to EORTC QLQ-BN20 [ Time Frame: Change from baseline to 3, 6, 12 and 24 months ]
    Quality of life measured by European Organization for Research and Treatment of Cancer (EORTC) questionnaire QLQ BN20



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03697343


Contacts
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Contact: Florian Putz, Dr. med. ++49(0)9131-85-33405 florian.putz@uk-erlangen.de

Locations
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Germany
Erlangen, Universitätsklinikum Strahlenklinik
Erlangen, Germany, 91054
Sponsors and Collaborators
University of Erlangen-Nürnberg Medical School
Investigators
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Principal Investigator: Rainer Fietkau, Prof. Universitätsklinikum Erlangen, Strahlenklinik
Principal Investigator: Florian Putz, Dr.med. Universitätsklinikum Erlangen, Strahlenklinik
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Responsible Party: University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier: NCT03697343    
Other Study ID Numbers: FSRT-Trial
First Posted: October 5, 2018    Key Record Dates
Last Update Posted: October 9, 2018
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasm Metastasis
Brain Neoplasms
Neoplastic Processes
Neoplasms
Pathologic Processes
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases