Hypofractionated Brain Radiationcavity
Stereotactic Radiosurgery or Hypofractionated Image-Guided Radiotherapy to the Surgical Cavity After Resection of Brain Metastases: a Multicenter, Single Arm, Open-label, Phase II Trial
1 other identifier
interventional
56
1 country
6
Brief Summary
Stereotactic radiosurgery or hypofractionated radiotherapy of the resection cavity after metastasectomy in cancer patients with brain metastases
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2015
Longer than P75 for not_applicable
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2015
CompletedFirst Submitted
Initial submission to the registry
January 19, 2017
CompletedFirst Posted
Study publicly available on registry
June 19, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 18, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 18, 2024
CompletedJuly 17, 2024
July 1, 2024
9.5 years
January 19, 2017
July 16, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Relapse rate
Evaluate the recurrence probability in the surgical cavity after radiotherapy
1 year
Secondary Outcomes (4)
Overall survival
1 year
Time to systemic progression
1 year
Time to neurological progression
1 year
Quality of life assessment
1 year
Study Arms (2)
IGRT
EXPERIMENTALImage-Guided Hypofractionated Stereotactic Radiation Therapy (IGRT) of the resection cavity
SRS
EXPERIMENTALStereotactic Radiosurgery of the resection cavity (SRS)
Interventions
Eligibility Criteria
You may qualify if:
- Patient underwent surgery for single brain metastasis arising from solid neoplasia (lung, breast, melanoma, kidney, colorectal), with initial histological diagnosis, or selected cases with a resected lesion and a further non-resected lesion (from 1 to 2 lesions), treatable with SRS / IGRT of the surgical cavity
- Patient ≥ 18 years
- Willngness to participate in the study, written informed consent
- Performance Status according to WHO 0-I
- Good general conditions and organ function
- Newly diagnosed chemotherapy-naïve disease or controlled systemic disease
- Good bone marrow, renal and hepatic function
- Stable steroid dose or reduced for at least 5 days
You may not qualify if:
- History of previous brain irradiation
- Pregnancy or breastfeeding
- Histological diagnosis other than lung, breast, melanoma, kidney and colorectal malignancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Oncology Institute of Southern Switzerland (IOSI)
Bellinzona, Canton Ticino, 6500, Switzerland
Universitätsspital Basel
Basel, 4031, Switzerland
Inselspital
Bern, 3010, Switzerland
Kantonsspital Winterthur
Winterthur, 8401, Switzerland
Klinik Hirslanden
Zurich, 8032, Switzerland
University Hospital Zurich (USZ)
Zurich, Switzerland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gianfranco A Pesce, MD
IOSI, Bellinzona, Switzerland
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
January 19, 2017
First Posted
June 19, 2018
Study Start
January 1, 2015
Primary Completion
June 18, 2024
Study Completion
June 18, 2024
Last Updated
July 17, 2024
Record last verified: 2024-07