Hypofractionated Brain Radiationcavity

Not Applicable

Completed

• Conditions: Brain Metastases, Adult; Cancer Brain
• Interventions: Radiation: IGRT; Radiation: SRS

• Registration Number: NCT03561896
• Lead Sponsor: Oncology Institute of Southern Switzerland

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.

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2017-01-19
• Study First Submitted QC: 2018-06-18
• Study First Posted: 2018-06-19
• Primary Completion: 2024-06-18
• Study Completion: 2024-06-18
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-16
• Last Update Posted: 2024-07-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

Not provided

Exclusion Criteria

• History of previous brain irradiation
• Pregnancy or breastfeeding
• Histological diagnosis other than lung, breast, melanoma, kidney and colorectal malignancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IGRT	IGRT	Image-Guided Hypofractionated Stereotactic Radiation Therapy (IGRT) of the resection cavity
SRS	SRS	Stereotactic Radiosurgery of the resection cavity (SRS)

Primary Outcome Measures

Name	Time	Method
Relapse rate	1 year	Evaluate the recurrence probability in the surgical cavity after radiotherapy

Secondary Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (6)

Klinik Hirslanden; 🇨🇭 Zürich, Switzerland

Universitätsspital Basel; 🇨🇭 Basel, Switzerland

Inselspital; 🇨🇭 Bern, Switzerland

University Hospital Zurich (USZ); 🇨🇭 Zürich, Switzerland

Oncology Institute of Southern Switzerland (IOSI); 🇨🇭 Bellinzona, Ticino, Switzerland

Kantonsspital Winterthur; 🇨🇭 Winterthur, Switzerland