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

NCT ID: NCT02848196

Last Updated: 2022-05-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-19
• Study Completion Date: 2023-01-31

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.

Conditions

Adrenal Gland Metastases

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Stereotactic Body Radiation Therapy

Intervention Type: RADIATION

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.

Interventions

Stereotactic 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.

Intervention Type: RADIATION

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istituto Clinico Humanitas

OTHER

Sponsor Role: lead

Responsible Party

Michele Tedeschi

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ciro Franzese, MD

Role: PRINCIPAL_INVESTIGATOR

Humanitas Cancer Center

Locations

Humanitas Research Hospital

Rozzano, Milan, Italy

Countries

Italy

Other Identifiers

1580

Identifier Type: -

Identifier Source: org_study_id