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

Thoracic Nodes Metastases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02970955
• Other study ID #: 1633
• Status: Completed
• Start date: March 22, 2017
• Est. completion date: December 1, 2022

Study information

• Verified date: February 2023
• Source: Istituto Clinico Humanitas
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: December 1, 2022
• Est. primary completion date: November 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neoplasm Metastasis
• Thoracic Nodes Metastases

Intervention

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

Locations

Country	Name	City	State
Italy	Davide Franceschini	Rozzano	Milano

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Clinico Humanitas

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Local control of disease	Local control of the thoracic nodes stereotactic radiation therapy schedules for medically inoperable oligometastatic patients	7 years
Secondary	Progression-free survival for patients	A measure of the activity of the SBRT treatment on the disease by statistical methods	7 years
Secondary	Overall survival for patients	Percentage of patients who are alive after a length of time	7 years
Secondary	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
Secondary	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