Hypofractionated Brain Radiationcavity

Brain Metastases, Adult Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03561896
• Other study ID #: IOSI-RTO-001
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 2015
• Est. completion date: December 2024

Study information

• Verified date: December 2023
• Source: Oncology Institute of Southern Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Metastases, Adult
• Brain Neoplasms
• Cancer Brain
• Neoplasm Metastasis

Intervention

Radiation:
• IGRT
Image-Guided Radiation Therapy
• SRS
stereotactic radiation therapy

Locations

Country	Name	City	State
Switzerland	Universitätsspital Basel	Basel
Switzerland	Oncology Institute of Southern Switzerland (IOSI)	Bellinzona	Ticino
Switzerland	Inselspital	Bern
Switzerland	Kantonsspital Winterthur	Winterthur
Switzerland	Klinik Hirslanden	Zürich
Switzerland	University Hospital Zurich (USZ)	Zürich

Sponsors (1)

Lead Sponsor	Collaborator
Oncology Institute of Southern Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relapse rate	Evaluate the recurrence probability in the surgical cavity after radiotherapy	1 year
Secondary	Overall survival	The proportion of surviving patients at 1 year	1 year
Secondary	Time to systemic progression	The proportion of patients with progression of disease in any location other than the brain, according to CTCAE Criteria	1 year
Secondary	Time to neurological progression	Time to neurological deterioration (objective neurological examination and MMSE)	1 year
Secondary	Quality of life assessment	Evaluation of the quality of life through questionnaire	1 year