Patients suffering from malignancies in advanced stages often develop brain metastases, which limit both the life span and the quality of life.
Therapy options for multiple brain metastases may vary and range from stereotactic radiosurgery (SRS), whole-brain radiotherapy (WBRT), chemotherapy, immunotherapy to palliative best supportive care. Especially the efficacy and toxicity of SRS compared to WBRT in patients with extensive brain metastases (\>4) is not yet clear but of incremental relevance in this seriously ill cohort with a limited life span. These health-impaired patients might especially profit from a less toxic treatment that is also time sparing with 1 or few sessions in SRS versus 10 sessions in WBRT. On the other hand, no compromises in efficacy want to be done.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* histologically confirmed malignant illness
* 4-15 suspect intracranial lesions, taking into consideration all available MRI series
* age ≥ 18 years of age
* For women with childbearing potential, (and men) adequate contraception.
* Ability of subject to understand character and individual consequences of the clinical trial
* Written informed consent (must be available before enrolment in the trial)
Exclusion Criteria:
* Refusal of the patients to take part in the study
* Inability to tolerate irradiation consistent with the protocol
* Small-cell lung cancer (SCLC) or lymphoma as primary malignant illness
* \>15 suspect intracranial lesions, taking into consideration all available MRI series
* leptomeningeal disease
* Previous radiotherapy of the brain
* Patients who have not yet recovered from acute high-grade toxicities of prior therapies
* Pregnant or lactating women
* Participation in another competing clinical study or observation period of competing trials, respectively
* MRI contraindication (i.e. cardiac pacemaker, implanted defibrillator, certain cardiac valve replacements, certain metal implants)
Primary outcome measure(s)
overall survival — time from randomisation until the date of death from any cause, assesd up to 24 month number of alive patients
quality of life according to QLQ-C15 (questionaire for patients with advanced cancer referred for palliative radiotherapy — time from randomisation until the date of death from any cause, assesd up to 24 month changes in QLQ-C15 scores, scale is 1-100 points, 100 points representing maximum score
quality of life according to BN-20 (questionaire for patients with brain neoplasm) — time from randomisation until the date of death from any cause, assesd up to 24 month changes in BN-20 scores, scale is 1-100 points, 100 points representing maximum score
Trial sites (1)
Facility
City
Region
Status
University Hospital of Heidelberg, Radiation Oncology
Heidelberg
Germany
Recruiting
More University Hospital Heidelberg trials in Germany
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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