Brain Metastases, Adult, Cancer Brain
Conditions
Keywords
Radation therapy, sterotactic radiosurgery, quality of life, solid cancer, palliation, neurologic functionning
Brief summary
Stereotactic radiosurgery or hypofractionated radiotherapy of the resection cavity after metastasectomy in cancer patients with brain metastases
Detailed description
Patients with limited number of brain metastases from solid tumors are at high risk of local recurrence after surgical removal of the tumor mass. The standard Whole-brain radiotherapy (WBRT) demonstrated to reduce the risk of recurrence without improving survival. At the same time WBRT have substantial acute and late toxicity. Preliminary experiences with Stereotactic radiosurgery or hypofractionated radiotherapy of the resection cavity indicate promising local control and good tolerance. This attitude was only partially explored in prospective trials. In this research patients with limited number of brain metastases and controlled systemic disease will be treated, with such a stereotactic irradiation, at the same time with evaluation of the local control (Primary endpoint) by repeated MRI and of quality of life, neurologic functionning (with a battery of thsts, e.g. MMSE, QLQ-C30, EORTC BN-20) as well as overall survival as secondary endpoints.
Sponsors
Oncology Institute of Southern Switzerland
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* History of previous brain irradiation * Pregnancy or breastfeeding * Histological diagnosis other than lung, breast, melanoma, kidney and colorectal malignancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Relapse rate | 1 year | Evaluate the recurrence probability in the surgical cavity after radiotherapy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | 1 year | The proportion of surviving patients at 1 year |
| Time to systemic progression | 1 year | The proportion of patients with progression of disease in any location other than the brain, according to CTCAE Criteria |
| Time to neurological progression | 1 year | Time to neurological deterioration (objective neurological examination and MMSE) |
| Quality of life assessment | 1 year | Evaluation of the quality of life through questionnaire |
Countries
Switzerland
Outcome results
None listed