Hypofractionated Brain Radiationcavity

Oncology Institute of Southern Switzerland56 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Brain Metastases, Adult Cancer Brain

Interventions

IGRTRADIATION

Image-Guided Radiation Therapy

SRSRADIATION

stereotactic radiation therapy

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (6)

Oncology Institute of Southern Switzerland (IOSI)

Bellinzona, Canton Ticino, Switzerland

Universitätsspital Basel

Basel, Switzerland

Inselspital

Bern, Switzerland

Kantonsspital Winterthur

Winterthur, Switzerland

Outcomes

Primary Outcomes

Relapse rate

Evaluate the recurrence probability in the surgical cavity after radiotherapy

Time frame: 1 year

Secondary Outcomes

Overall survival

The proportion of surviving patients at 1 year

Time frame: 1 year

Time to systemic progression

The proportion of patients with progression of disease in any location other than the brain, according to CTCAE Criteria

Time frame: 1 year

Time to neurological progression

Time to neurological deterioration (objective neurological examination and MMSE)

Time frame: 1 year

Quality of life assessment

Evaluation of the quality of life through questionnaire

Time frame: 1 year

Data from ClinicalTrials.gov

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