Hypofractionated Brain Radiationcavity

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Brain Metastases, Adult; Cancer Brain
• Intervention / Treatment: Radiation: IGRT; Radiation: SRS

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 Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gianfranco A Pesce, MD; Phone Number: +41918119253; Email: GianfrancoAngelo.pesce@eoc.ch
• Study Contact Backup: Name: Che N Azinwi, MD; Phone Number: +41918118932; Email: NgwaChe.Azinwi@eoc.ch

Study Locations

• Switzerland
  • Basel, Switzerland, 4031
    • Universitätsspital Basel
  • Bern, Switzerland, 3010
    • Inselspital
  • Winterthur, Switzerland, 8401
    • Kantonsspital Winterthur
  • Zürich, Switzerland, 8032
    • Klinik Hirslanden
  • Zürich, Switzerland
    • University Hospital Zurich (USZ)
  • Ticino
    • Bellinzona, Ticino, Switzerland, 6500
      • Oncology Institute of Southern Switzerland (IOSI)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IGRT; Image-Guided Hypofractionated Stereotactic Radiation Therapy (IGRT) of the resection cavity	Radiation: IGRT; Image-Guided Radiation Therapy
Experimental: SRS; Stereotactic Radiosurgery of the resection cavity (SRS)	Radiation: SRS; stereotactic radiation therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relapse rate	Evaluate the recurrence probability in the surgical cavity after radiotherapy	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival	The proportion of surviving patients at 1 year	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	1 year
Time to neurological progression	Time to neurological deterioration (objective neurological examination and MMSE)	1 year
Quality of life assessment	Evaluation of the quality of life through questionnaire	1 year

Collaborators and Investigators

• Sponsor: Oncology Institute of Southern Switzerland
• Investigators: Principal Investigator: Gianfranco A Pesce, MD, IOSI, Bellinzona, Switzerland

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2015
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: January 19, 2017
• First Submitted That Met QC Criteria: June 18, 2018
• First Posted (Actual): June 19, 2018

Study Record Updates

• Last Update Posted (Actual): December 21, 2023
• Last Update Submitted That Met QC Criteria: December 20, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: quality of life; palliation; solid cancer; Radation therapy; sterotactic radiosurgery; neurologic functionning
• Additional Relevant MeSH Terms: Pathologic Processes; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms; Neoplasms by Site; Neoplastic Processes; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasm Metastasis; Brain Neoplasms
• Other Study ID Numbers: IOSI-RTO-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED