NCT02848196

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 21, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 28, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

October 19, 2016

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
Last Updated

May 4, 2022

Status Verified

May 1, 2022

Enrollment Period

6.2 years

First QC Date

July 21, 2016

Last Update Submit

May 3, 2022

Conditions

Adrenal Gland Metastases

Outcome Measures

Primary Outcomes (1)

  • Control of local disease

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

    5 years

Secondary Outcomes (2)

  • Incidence of acute and late complications

    5 years

  • Endocrine mechanisms of hormonal production

    5 years

Study Arms (1)

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.

Radiation: Stereotactic Body Radiation Therapy

Interventions

Stereotactic Body Radiation TherapyRADIATION

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.

Stereotactic body radiation therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 18years.
  • WHO performance status ≤ 1 (ECOG - KPS).
  • Histologically-proven of primary cancer disease
  • Metastases at adrenal gland radiologically proven
  • Written informed consent

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Humanitas Research Hospital

Rozzano, Milan, 20089, Italy

Location

MeSH Terms

Interventions

Radiosurgery

Intervention Hierarchy (Ancestors)

RadiotherapyTherapeuticsStereotaxic TechniquesNeurosurgical ProceduresSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Ciro Franzese, MD

    Humanitas Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

July 21, 2016

First Posted

July 28, 2016

Study Start

October 19, 2016

Primary Completion

January 1, 2023

Study Completion

January 1, 2023

Last Updated

May 4, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)