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

A Phase II Trial of Image-guided Stereotactic Body Radiation Therapy (SBRT) for Adrenal Gland Metastasis in Oligometastatic Patients

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02848196

Enrollment

Registered

2016-07-28

Start date

2016-10-19

Completion date

2023-01-31

Last updated

2022-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adrenal Gland Metastases

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.

Interventions

RADIATIONStereotactic Body Radiation Therapy

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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026