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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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 technique in oligometastatic patients affected by adrenal gland metastases.

Detailed Summary: 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.
Sponsor: Istituto Clinico Humanitas

Current Primary Outcome: Control of local disease [ Time Frame: 5 years ]

Evaluation of proportion of patients free from progression from starting radiotherapy according to CTCAE v4.03


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Incidence of acute and late complications [ Time Frame: 5 years ]
    Evaluation of early and late post treatment complications
  • Endocrine mechanisms of hormonal production [ Time Frame: 5 years ]
    Assessment acute and late toxicity in terms of maintenance of endocrine mechanisms of hormonal production according to CTCAE v4.03


Original Secondary Outcome:

  • Incidence of acute and late complications [ Time Frame: 5 years ]
    Evaluation of early and late post treatment complications
  • To assess the endocrine mechanisms of hormonal production [ Time Frame: 5 years ]
    Assessment acute and late toxicity in terms of mantainance of endocrine mechanisms of hormonal production according to CTCAE v4.03


Information By: Istituto Clinico Humanitas

Dates:
Date Received: July 21, 2016
Date Started: July 2016
Date Completion: July 2021
Last Updated: July 28, 2016
Last Verified: July 2016