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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Thoracic Nodes Metastases

Intervention / Treatment
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* Procedure: Inoperable thoracic nodes metastases


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Inoperable thoracic nodes metastases<br>Oligometastatic patients with inoperable thoracic nodes metastases from any primary | Procedure: Inoperable thoracic nodes metastases<br>* 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<br>|

What is the study measuring?
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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 |