Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Inoperable thoracic nodes metastases | Oligometastatic patients with inoperable thoracic nodes metastases from any primary |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Patients with inoperable thoracic nodes metastases from any primary, except for hematologic malignancies
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Davide Franceschini, MD | Istituto Clinico Humanitas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Davide Franceschini | Rozzano | Milano | 20090 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38772477 | Derived | Franceschini D, Teriaca MA, Mancosu P, Bertolini A, Lo Faro L, Spoto R, Dominici L, Badalamenti M, Bellu L, Dei D, La Fauci F, Franzese C, Scorsetti M. Prospective phase II trial on ablative stereotactic body radiation therapy (SBRT) for medically inoperable thoracic nodes metastases. Radiother Oncol. 2024 Aug;197:110335. doi: 10.1016/j.radonc.2024.110335. Epub 2024 May 19. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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 |