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

Overview

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).

Full Title of Study: “Prospective Observational Study on a Risk Adaptive Scheme for Stereotactic Body Radiation Therapy (SBRT) for Medically Inoperable Thoracic Nodes Metastases”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: November 1, 2022

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.

Interventions

  • 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

Arms, Groups and Cohorts

  • Inoperable thoracic nodes metastases
    • Oligometastatic patients with inoperable thoracic nodes metastases from any primary

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Istituto Clinico Humanitas
  • Provider of Information About this Clinical Study
    • Principal Investigator: Michele Tedeschi, Medical Doctor – Istituto Clinico Humanitas
  • Overall Official(s)
    • Davide Franceschini, MD, Principal Investigator, Istituto Clinico Humanitas

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