An Image-guided SBRT for Adrenal Gland Metastasis in Oligometastatic Patients

Not Applicable

• Conditions: Adrenal Gland Metastases
• Interventions: Radiation: Stereotactic Body Radiation Therapy

• Registration Number: NCT02848196
• Lead Sponsor: Istituto Clinico Humanitas

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.

Study Timeline

• Study First Submitted: 2016-07-21
• Study First Submitted QC: 2016-07-25
• Study First Posted: 2016-07-28
• Study Start: 2016-10-19
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-03
• Last Update Posted: 2022-05-04
• Primary Completion: 2023-01
• Study Completion: 2023-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Stereotactic body radiation therapy	Stereotactic Body Radiation Therapy	Oligometastatic patients with adrenal gland metastases are treated with high dose of Stereotactic Body Radiation Therapy delivered with VMAT/Rapid Arc technique.

Primary Outcome Measures

Name	Time	Method
Control of local disease	5 years	Evaluation of proportion of patients free from progression from starting radiotherapy according to CTCAE v4.03

Secondary Outcome Measures

Name	Time	Method
Incidence of acute and late complications	5 years	Evaluation of early and late post treatment complications
Endocrine mechanisms of hormonal production	5 years	Assessment acute and late toxicity in terms of maintenance of endocrine mechanisms of hormonal production according to CTCAE v4.03

Trial Locations

Locations (1)

Humanitas Research Hospital; 🇮🇹 Rozzano, Milan, Italy