Clinical trial NCT03561896: Hypofractionated Brain Radiationcavity
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Brain Metastases, Adult
Cancer Brain
Keywords: Radation therapy
sterotactic radiosurgery
quality of life
solid cancer
palliation
neurologic functionning
Lead sponsor: Oncology Institute of Southern Switzerland
Sponsor class: OTHER
First posted: 2018-06-19
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Relapse rate
timeFrame: 1 year
Secondary outcomes:
measure: Overall survival
timeFrame: 1 year
measure: Time to systemic progression
timeFrame: 1 year
measure: Time to neurological progression
timeFrame: 1 year
measure: Quality of life assessment
timeFrame: 1 year
Other outcomes:
Locations:
city: Bellinzona
country: Switzerland
facility: Oncology Institute of Southern Switzerland (IOSI)
state: Ticino
city: Basel
country: Switzerland
facility: Universitätsspital Basel
city: Bern
country: Switzerland
facility: Inselspital
city: Winterthur
country: Switzerland
facility: Kantonsspital Winterthur
city: Zürich
country: Switzerland
facility: Klinik Hirslanden
city: Zürich
country: Switzerland
facility: University Hospital Zurich (USZ)
Study officials:
affiliation: IOSI, Bellinzona, Switzerland
name: Gianfranco A Pesce, MD
role: PRINCIPAL_INVESTIGATOR
References: