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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Adrenal Gland Metastases

Intervention / Treatment
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* Radiation: Stereotactic Body Radiation Therapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stereotactic body radiation therapy<br>Oligometastatic patients with adrenal gland metastases are treated with high dose of Stereotactic Body Radiation Therapy delivered with VMAT/Rapid Arc technique. | Radiation: Stereotactic Body Radiation Therapy<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of acute and late complications | Evaluation of early and late post treatment complications | 5 years | 
| 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 | 5 years |