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

Completed

• Conditions: Thoracic Nodes Metastases
• Interventions: Procedure: Inoperable thoracic nodes metastases

• Registration Number: NCT02970955
• Lead Sponsor: Istituto Clinico Humanitas

Brief Summary

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).

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 Timeline

• Study First Submitted: 2016-11-16
• Study First Submitted QC: 2016-11-18
• Study First Posted: 2016-11-22
• Study Start: 2017-03-22
• Primary Completion: 2022-11-01
• Study Completion: 2022-12-01
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-03
• Last Update Posted: 2023-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Inoperable thoracic nodes metastases	Inoperable thoracic nodes metastases	Oligometastatic patients with inoperable thoracic nodes metastases from any primary

Primary Outcome Measures

Name	Time	Method
Local control of disease	7 years	Local control of the thoracic nodes stereotactic radiation therapy schedules for medically inoperable oligometastatic patients

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Davide Franceschini; 🇮🇹 Rozzano, Milano, Italy