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

Adrenal Gland Metastases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02848196
• Other study ID #: 1580
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 19, 2016
• Est. completion date: January 2023

Study information

• Verified date: May 2022
• Source: Istituto Clinico Humanitas
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: January 2023
• Est. primary completion date: January 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Adrenal Gland Metastases
• Adrenal Gland Neoplasms
• Neoplasm Metastasis

Intervention

Radiation:
• 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.

Locations

Country	Name	City	State
Italy	Humanitas Research Hospital	Rozzano	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Clinico Humanitas

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Control of local disease	Evaluation of proportion of patients free from progression from starting radiotherapy according to CTCAE v4.03	5 years
Secondary	Incidence of acute and late complications	Evaluation of early and late post treatment complications	5 years
Secondary	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