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

Istituto Clinico Humanitas

Status: Unknown

Conditions: Adrenal Gland Metastases

Treatments: Radiation: Stereotactic Body Radiation Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02848196

1580

Details and patient eligibility

About

The study is designed to to assess the efficacy of ablative SBRT delivered with VMAT technique in oligometastatic patients affected by adrenal gland metastases.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Stereotactic body radiation therapy

Experimental group

Description:

Oligometastatic patients with adrenal gland metastases are treated with high dose of Stereotactic Body Radiation Therapy delivered with VMAT/Rapid Arc technique.

Treatment:

Radiation: Stereotactic Body Radiation Therapy