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The study is designed to to assess the efficacy of ablative SBRT delivered with VMAT technique in oligometastatic patients affected by adrenal gland metastases.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stereotactic body radiation therapy | Experimental | Oligometastatic patients with adrenal gland metastases are treated with high dose of Stereotactic Body Radiation Therapy delivered with VMAT/Rapid Arc technique. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stereotactic Body Radiation Therapy | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Control of local disease | Evaluation of proportion of patients free from progression from starting radiotherapy according to CTCAE v4.03 | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of acute and late complications | Evaluation of early and late post treatment complications | 5 years |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ciro Franzese, MD | Humanitas Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Humanitas Research Hospital | Rozzano | Milan | 20089 | Italy |
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| ID | Term |
|---|---|
| D016634 | Radiosurgery |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D013238 | Stereotaxic Techniques |
| D019635 | Neurosurgical Procedures |
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| 5 years |
| D013514 |
| Surgical Procedures, Operative |
| D008919 | Investigative Techniques |