Hypofractionated Brain Radiationcavity

Oncology Institute of Southern Switzerland (IOSI)

Status

Completed

Conditions

Brain Metastases, Adult

Cancer Brain

Treatments

Radiation: SRS

Radiation: IGRT

Study type

Interventional

Funder types

Other

Identifiers

NCT03561896

IOSI-RTO-001

Details and patient eligibility

About

Stereotactic radiosurgery or hypofractionated radiotherapy of the resection cavity after metastasectomy in cancer patients with brain metastases

Full 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.

Enrollment

56 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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