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

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ClinicalTrials.gov Identifier: NCT02848196
Recruitment Status : Recruiting
First Posted : July 28, 2016
Last Update Posted : October 24, 2018
Sponsor:
Information provided by (Responsible Party):
Michele Tedeschi, Istituto Clinico Humanitas

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.

Condition or disease Intervention/treatment Phase
Adrenal Gland Metastases Radiation: Stereotactic Body Radiation Therapy Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 37 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial of Image-guided Stereotactic Body Radiation Therapy (SBRT) for Adrenal Gland Metastasis in Oligometastatic Patients
Actual Study Start Date : October 19, 2016
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : July 2021


Arm Intervention/treatment
Experimental: 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.
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.




Primary Outcome Measures :
  1. Control of local disease [ Time Frame: 5 years ]
    Evaluation of proportion of patients free from progression from starting radiotherapy according to CTCAE v4.03


Secondary Outcome Measures :
  1. Incidence of acute and late complications [ Time Frame: 5 years ]
    Evaluation of early and late post treatment complications

  2. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02848196


Contacts
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Contact: Ciro Franzese, MD +390282247454 ciro.franzese@cancercenter.humanitas.it

Locations
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Italy
Humanitas Research Hospital Recruiting
Rozzano, Milan, Italy, 20089
Contact: Ciro Franzese, MD    +390282247454    ciro.franzese@cancercenter.humanitas.it   
Principal Investigator: Ciro Franzese, MD         
Sub-Investigator: Lucia Di Brina, MD         
Sub-Investigator: Davide Franceschini, MD         
Sponsors and Collaborators
Istituto Clinico Humanitas
Investigators
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Principal Investigator: Ciro Franzese, MD Humanitas Cancer Center

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Responsible Party: Michele Tedeschi, MD, Istituto Clinico Humanitas
ClinicalTrials.gov Identifier: NCT02848196     History of Changes
Other Study ID Numbers: 1580
First Posted: July 28, 2016    Key Record Dates
Last Update Posted: October 24, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Neoplasm Metastasis
Adrenal Gland Neoplasms
Neoplastic Processes
Neoplasms
Pathologic Processes
Endocrine Gland Neoplasms
Neoplasms by Site
Adrenal Gland Diseases
Endocrine System Diseases
Epinephrine
Racepinephrine
Epinephryl borate
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Sympathomimetics
Vasoconstrictor Agents