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Tumor Bed Hypofractionated IMRT After Surgery for Patients With Single,Large Brain Metastases From Solid Tumor

Primary Purpose

Brain Metastases

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
brain metastatic patients
Sponsored by
Istituto Clinico Humanitas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain Metastases

Eligibility Criteria

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

Inclusion Criteria:

  • Age > 18 years
  • Karnosky performance status (KPS) ≥70
  • All Solid tumor (esclusion SCLC and Germinal tumors)
  • Controlled primary tumor
  • Controlled other metastatic site
  • Single metastatic lesion at diagnosis
  • Lesions ≥ 2.1 cm in maximum diameter (4 cm3), < 3 cm conditioning mass effect or neurological deficits or massive aedema, unknown primary tumor
  • Estimated survival ≥ 3 months.
  • Written informed consent

Exclusion Criteria:

  • Prior WBRT
  • KPS ≤ 70
  • Other primary cancer
  • Pregnant women

Sites / Locations

  • Istituto Clinico Humanitas

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

brain metastatic patients

Arm Description

Patients with single, large brain metastases from solid tumors

Outcomes

Primary Outcome Measures

Local control rate

Secondary Outcome Measures

Distant brain failure
Overall survival, statistical
Morbidity/mortality after surgery
Radionecrosis after treatments
Neuropsycological alterations after treatments, questionnaire

Full Information

First Posted
October 7, 2015
Last Updated
May 24, 2019
Sponsor
Istituto Clinico Humanitas
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1. Study Identification

Unique Protocol Identification Number
NCT02576522
Brief Title
Tumor Bed Hypofractionated IMRT After Surgery for Patients With Single,Large Brain Metastases From Solid Tumor
Official Title
Tumor Bed Hypofractionated IMRT (VMAT-RA) After Surgical Resection for Patients With Single, Large (≥2.1 cm) Brain Metastases From Solid Tumor
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
June 29, 2015 (Actual)
Primary Completion Date
January 22, 2019 (Actual)
Study Completion Date
January 22, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istituto Clinico Humanitas

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Investigators designed a study of a multimodality approach: surgery followed by hypofractionated intensity modulated radiation therapy (IMRT) using VMAT approach for patients with single, large brain metastases from solid primary tumor
Detailed Description
Investigators designed a study to recruit patients with single, large brain metastases from solid primary tumor for a multimodality approach: surgery followed by hypofractionated intensity modulated radiation therapy (IMRT) using VMAT approach. The potential advantage of this treatment is to improve local control and to reduce toxicity compared with WBRT or SRS after surgical resection.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Metastases

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
87 (Actual)

8. Arms, Groups, and Interventions

Arm Title
brain metastatic patients
Arm Type
Experimental
Arm Description
Patients with single, large brain metastases from solid tumors
Intervention Type
Radiation
Intervention Name(s)
brain metastatic patients
Intervention Description
Surgery followed by hypofractionated intensity modulated radiation therapy (IMRT) using VMAT approach
Primary Outcome Measure Information:
Title
Local control rate
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Distant brain failure
Time Frame
6 months
Title
Overall survival, statistical
Time Frame
6 months
Title
Morbidity/mortality after surgery
Time Frame
1 month
Title
Radionecrosis after treatments
Time Frame
6 months
Title
Neuropsycological alterations after treatments, questionnaire
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age > 18 years Karnosky performance status (KPS) ≥70 All Solid tumor (esclusion SCLC and Germinal tumors) Controlled primary tumor Controlled other metastatic site Single metastatic lesion at diagnosis Lesions ≥ 2.1 cm in maximum diameter (4 cm3), < 3 cm conditioning mass effect or neurological deficits or massive aedema, unknown primary tumor Estimated survival ≥ 3 months. Written informed consent Exclusion Criteria: Prior WBRT KPS ≤ 70 Other primary cancer Pregnant women
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierina Navarria, MD
Organizational Affiliation
Istituto Clinico Humanitas
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istituto Clinico Humanitas
City
Rozzano
State/Province
Milano
ZIP/Postal Code
20089
Country
Italy

12. IPD Sharing Statement

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Tumor Bed Hypofractionated IMRT After Surgery for Patients With Single,Large Brain Metastases From Solid Tumor

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