Prospecitve Observational Study on a Risk Adaptive Scheme for SBRT for Thoracic Nodes Metastases

Prospective Observational Study on a Risk Adaptive Scheme for Stereotactic Body Radiation Therapy (SBRT) for Medically Inoperable Thoracic Nodes Metastases

Oligometastatic patients with inoperable thoracic nodes metastases from any primary, except for hematologic malignancies, will undergo a risk adaptive scheme of stereotactic body radiation therapy (SBRT).

Study Overview

• Status: Completed
• Conditions: Thoracic Nodes Metastases
• Intervention / Treatment: Procedure: Inoperable thoracic nodes metastases

Detailed Description

The observational study is designed to evaluate safety and efficacy of a risk adaptive scheme of stereotactic body radiation therapy (SRT) in oligometastatic patients with thoracic nodes metastases, medically inoperable, using VMAT RapidArc approach. The potential advantage of this technique is the ability to deliver a more selective irradiation to tumour's target while reducing doses to normal tissue, optimizing the therapeutic window.

• Study Type: Observational
• Enrollment (Actual): 32

Contacts and Locations

Study Locations

• Italy
  • Milano
    • Rozzano, Milano, Italy, 20090
      • Davide Franceschini

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with inoperable thoracic nodes metastases from any primary, except for hematologic malignancies

Description

Inclusion Criteria:

• Patients aged >18 years with ECOG 0-2
• Karnofsky index > 70% (ECOG >2)
• Any primary, except for hematologic malignancies
• DFI (Disease-free interval) from diagnosis > 6 months
• Unresectable lesions or inoperable patients or patients who refused surgery
• Less than 3 metastatic thoracic nodes
• No extrathoracic disease or other metastatic sites stable or responding after chemotherapy, with less than 5 metastatic sites
• No life threatening conditions
• Chemotherapy completed at least 1 week before treatment
• Chemotherapy started at least 1 week after treatment allowed
• Systemic therapies other than chemotherapy allowed (i.e hormonal therapies and/or immunotherapy)
• Written informed consent

Exclusion Criteria:

• Previous RT in the same region
• Pregnant women
• Patients with inability to consent

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Inoperable thoracic nodes metastases; Oligometastatic patients with inoperable thoracic nodes metastases from any primary	Procedure: Inoperable thoracic nodes metastases; The radiation treatment will be delivered with three possible schedules, with a risk adaptive scheme according to number, site and size of metastatic nodes and based on the possibility to respect the constraints of healthy tissues

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Local control of disease	Local control of the thoracic nodes stereotactic radiation therapy schedules for medically inoperable oligometastatic patients	7 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free survival for patients	A measure of the activity of the SBRT treatment on the disease by statistical methods	7 years
Overall survival for patients	Percentage of patients who are alive after a length of time	7 years
Quality of life evaluated by EORTC QLQ C30 questionnaires	At the end of the treatment and during the first follow-up appointment patients will complete the EORTC QLQ C30	7 years
Hematologic and non-hematologic toxicities	Hematologic and non-hematologic toxicities will be graded according to Common Terminology Criteria for Adverse Events version 4.0	7 years

Collaborators and Investigators

• Sponsor: Istituto Clinico Humanitas
• Investigators: Principal Investigator: Davide Franceschini, MD, Istituto Clinico Humanitas

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 22, 2017
• Primary Completion (ACTUAL): November 1, 2022
• Study Completion (ACTUAL): December 1, 2022

Study Registration Dates

• First Submitted: November 16, 2016
• First Submitted That Met QC Criteria: November 18, 2016
• First Posted (ESTIMATE): November 22, 2016

Study Record Updates

• Last Update Posted (ACTUAL): February 6, 2023
• Last Update Submitted That Met QC Criteria: February 3, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Neoplastic Processes; Neoplasm Metastasis
• Other Study ID Numbers: 1633

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO