Have you or your loved ones been diagnosed with adrenal gland metastases?

You may be eligible to participate in a adrenal gland metastases clinical trial.

Have you or your loved ones been diagnosed with adrenal gland metastases? You may be eligible to participate in a adrenal gland metastases clinical trial.

What is a clinical trial? Is participating in a clinical trial right for you? Learn more

Adrenal Gland Metastases Clinical Trial in Rozzano Milan

NCT02848196 | Interventional

Have you or your loved ones been diagnosed with adrenal gland metastases?

You may be eligible to participate in a adrenal gland metastases clinical trial.

Have you or your loved ones been diagnosed with adrenal gland metastases? You may be eligible to participate in a adrenal gland metastases clinical trial.

Active not recruiting

Male & Female

18 Years +

This study has recruited 40 Participants

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

Show me more details

Details for the study

Brief Title

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

Official Title

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

Brief Summary

The study is designed to to assess the efficacy of ablative SBRT delivered with VMAT <br /> 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.

Treatments and/or Procedures

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.

Outcome Measures

Outcome measures are the tests that investigators perform to prove whether or not a treatment being tested in a clinical trial is having any effect.

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

Study 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.