Hypofractionated Brain Radiationcavity

NCT ID: NCT03561896

Last Updated: 2024-07-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2024-06-18

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.

Conditions

Brain Metastases, Adult; Cancer Brain

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

IGRT

Image-Guided Hypofractionated Stereotactic Radiation Therapy (IGRT) of the resection cavity

Group Type: EXPERIMENTAL

IGRT

Intervention Type: RADIATION

Image-Guided Radiation Therapy

SRS

Stereotactic Radiosurgery of the resection cavity (SRS)

Group Type: EXPERIMENTAL

SRS

Intervention Type: RADIATION

stereotactic radiation therapy

Interventions

IGRT

Image-Guided Radiation Therapy

Intervention Type: RADIATION

SRS

stereotactic radiation therapy

Intervention Type: RADIATION

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Oncology Institute of Southern Switzerland

OTHER

Sponsor Role: lead

Responsible Party

Gianfranco Angelo Pesce

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gianfranco A Pesce, MD

Role: PRINCIPAL_INVESTIGATOR

IOSI, Bellinzona, Switzerland

Locations

Oncology Institute of Southern Switzerland (IOSI)

Bellinzona, Canton Ticino, Switzerland

Universitätsspital Basel

Basel, , Switzerland

Inselspital

Bern, , Switzerland

Kantonsspital Winterthur

Winterthur, , Switzerland

Klinik Hirslanden

Zurich, , Switzerland

University Hospital Zurich (USZ)

Zurich, , Switzerland

Countries

Switzerland

Other Identifiers

IOSI-RTO-001

Identifier Type: -

Identifier Source: org_study_id