An Image-guided SBRT for Adrenal Gland Metastasis in Oligometastatic Patients
Primary Purpose
Adrenal Gland Metastases
Status
Active
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Stereotactic Body Radiation Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Adrenal Gland Metastases
Eligibility Criteria
Inclusion Criteria:
- Age ≥ 18years.
- WHO performance status ≤ 1 (ECOG - KPS).
- Histologically-proven of primary cancer disease
- Metastases at adrenal gland radiologically proven
- Written informed consent
Exclusion Criteria:
- Prior radiation to the interested adrenal gland.
- Patients allergic to contrast used in CT scans or who cannot be premedicated for the use of contrast.
Sites / Locations
- Humanitas Research Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Stereotactic body radiation therapy
Arm Description
Oligometastatic patients with adrenal gland metastases are treated with high dose of Stereotactic Body Radiation Therapy delivered with VMAT/Rapid Arc technique.
Outcomes
Primary Outcome Measures
Control of local disease
Evaluation of proportion of patients free from progression from starting radiotherapy according to CTCAE v4.03
Secondary Outcome Measures
Incidence of acute and late complications
Evaluation of early and late post treatment complications
Endocrine mechanisms of hormonal production
Assessment acute and late toxicity in terms of maintenance of endocrine mechanisms of hormonal production according to CTCAE v4.03
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02848196
Brief Title
An Image-guided SBRT for Adrenal Gland Metastasis in Oligometastatic Patients
Official Title
A Phase II Trial of Image-guided Stereotactic Body Radiation Therapy (SBRT) for Adrenal Gland Metastasis in Oligometastatic Patients
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 19, 2016 (Actual)
Primary Completion Date
January 2023 (Anticipated)
Study Completion Date
January 2023 (Anticipated)
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
The study is designed to to assess the efficacy of ablative SBRT delivered with VMAT technique in oligometastatic patients affected by adrenal gland metastases.
Detailed Description
This is a phase II, single arm, trial for testing efficacy of ablative high hypofractionated dose delivered with VMAT technique in oligometastatic patients with adrenal gland metastases. The potential advantages of this approach include the possibility to lead an increased local control in irradiated adrenal gland metastases. Other purpose of this study is to assess acute and late toxicity in terms of maintenance of endocrine mechanisms of hormonal production.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adrenal Gland 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
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Stereotactic body radiation therapy
Arm Type
Experimental
Arm Description
Oligometastatic patients with adrenal gland metastases are treated with high dose of Stereotactic Body Radiation Therapy delivered with VMAT/Rapid Arc technique.
Intervention Type
Radiation
Intervention Name(s)
Stereotactic Body Radiation Therapy
Intervention Description
The schedule will be 3 fractions of 15 Gy up to a total dose of 45 Gy delivered every day with VMAT and Flattening filter-free (FFF) beams. Image-guided systems, including CBCT, will be used for all patients.
Primary Outcome Measure Information:
Title
Control of local disease
Description
Evaluation of proportion of patients free from progression from starting radiotherapy according to CTCAE v4.03
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Incidence of acute and late complications
Description
Evaluation of early and late post treatment complications
Time Frame
5 years
Title
Endocrine mechanisms of hormonal production
Description
Assessment acute and late toxicity in terms of maintenance of endocrine mechanisms of hormonal production according to CTCAE v4.03
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age ≥ 18years.
WHO performance status ≤ 1 (ECOG - KPS).
Histologically-proven of primary cancer disease
Metastases at adrenal gland radiologically proven
Written informed consent
Exclusion Criteria:
Prior radiation to the interested adrenal gland.
Patients allergic to contrast used in CT scans or who cannot be premedicated for the use of contrast.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ciro Franzese, MD
Organizational Affiliation
Humanitas Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Humanitas Research Hospital
City
Rozzano
State/Province
Milan
ZIP/Postal Code
20089
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
An Image-guided SBRT for Adrenal Gland Metastasis in Oligometastatic Patients
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