Completed

NCT Number: NCT02970955

Prospecitve Observational Study on a Risk Adaptive Scheme for SBRT for 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).

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Key information

Conditions

Thoracic Nodes Metastases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Davide Franceschini

Rozzano, Milano, 20090, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Inoperable thoracic nodes metastases

Procedure

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

Primary outcomes

Local control of disease

Time frame: 7 years

Local control of the thoracic nodes stereotactic radiation therapy schedules for medically inoperable oligometastatic patients

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

Istituto Clinico Humanitas

Other

Registry information

Official study title

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

Important dates

Study start: 2017
Primary completion: 2022
Study completion: 2022
First posted: Nov 22, 2016
Registry last updated: Feb 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.