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Hypofractionated Brain Radiationcavity

Primary Purpose

Brain Metastases, Adult, Cancer Brain

Status
Active
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
IGRT
SRS
Sponsored by
Oncology Institute of Southern Switzerland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain Metastases, Adult focused on measuring Radation therapy, sterotactic radiosurgery, quality of life, solid cancer, palliation, neurologic functionning

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Oncology Institute of Southern Switzerland (IOSI)
  • Universitätsspital Basel
  • Inselspital
  • Kantonsspital Winterthur
  • Klinik Hirslanden
  • University Hospital Zurich (USZ)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

IGRT

SRS

Arm Description

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

Stereotactic Radiosurgery of the resection cavity (SRS)

Outcomes

Primary Outcome Measures

Relapse rate
Evaluate the recurrence probability in the surgical cavity after radiotherapy

Secondary Outcome Measures

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

Full Information

First Posted
January 19, 2017
Last Updated
September 12, 2023
Sponsor
Oncology Institute of Southern Switzerland
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1. Study Identification

Unique Protocol Identification Number
NCT03561896
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 2015 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oncology Institute of Southern Switzerland

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Metastases, Adult, Cancer Brain
Keywords
Radation therapy, sterotactic radiosurgery, quality of life, solid cancer, palliation, neurologic functionning

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
IGRT
Arm Type
Experimental
Arm Description
Image-Guided Hypofractionated Stereotactic Radiation Therapy (IGRT) of the resection cavity
Arm Title
SRS
Arm Type
Experimental
Arm Description
Stereotactic Radiosurgery of the resection cavity (SRS)
Intervention Type
Radiation
Intervention Name(s)
IGRT
Intervention Description
Image-Guided Radiation Therapy
Intervention Type
Radiation
Intervention Name(s)
SRS
Intervention Description
stereotactic radiation therapy
Primary Outcome Measure Information:
Title
Relapse rate
Description
Evaluate the recurrence probability in the surgical cavity after radiotherapy
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Overall survival
Description
The proportion of surviving patients at 1 year
Time Frame
1 year
Title
Time to systemic progression
Description
The proportion of patients with progression of disease in any location other than the brain, according to CTCAE Criteria
Time Frame
1 year
Title
Time to neurological progression
Description
Time to neurological deterioration (objective neurological examination and MMSE)
Time Frame
1 year
Title
Quality of life assessment
Description
Evaluation of the quality of life through questionnaire
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gianfranco A Pesce, MD
Organizational Affiliation
IOSI, Bellinzona, Switzerland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oncology Institute of Southern Switzerland (IOSI)
City
Bellinzona
State/Province
Ticino
ZIP/Postal Code
6500
Country
Switzerland
Facility Name
Universitätsspital Basel
City
Basel
ZIP/Postal Code
4031
Country
Switzerland
Facility Name
Inselspital
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Facility Name
Kantonsspital Winterthur
City
Winterthur
ZIP/Postal Code
8401
Country
Switzerland
Facility Name
Klinik Hirslanden
City
Zürich
ZIP/Postal Code
8032
Country
Switzerland
Facility Name
University Hospital Zurich (USZ)
City
Zürich
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Hypofractionated Brain Radiationcavity

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