Ignite Creation Date:
2024-05-06 @ 8:15 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06310564
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-15
First Post:
2024-03-07
Brief Title:
Low and Intermediate Risk oliGometastatic coloREctal cancEr patieNts Treated With Stereotactic ABlative Radiotherapy
Sponsor:
IRCCS Sacro Cuore Don Calabria di Negrar
Organization:
IRCCS Sacro Cuore Don Calabria di Negrar
Study Overview
Official Title:
A Prospective Randomized Clinical Trial of Low and Intermediate Risk oliGometastatic coloREctal cancEr patieNts Treated With Stereotactic ABlative Radiotherapy GREEN LaIT-SABR Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GREENLaIT-SABR
Brief Summary:
This is an experimental study without drug or device randomized open-label non-profit sponsored by the IRCCS Sacro Cuore Don Calabria Hospital in Negrar which will take place at the Department of Advanced Oncological Radiotherapy and 18 other Italian centers
The reason for this research study is to evaluate whether stereotactic radiotherapy treatment SABR in addition to the systemic chemotherapy treatment foreseen by clinical practice for low-intermediate risk oligometastatic colorectal cancer is able to
delay possible local recurrence andor distant polymetastatic progression
improve disease-free survival
reduce side effects in the short and long term
thus inducing an improvement in the quality of life of patients suffering from this type of pathology
Therefore as part of this randomized study before starting first or second line systemic therapy for his tumor the patient will be randomized to one of the following treatment arms
Experimental arm ablative stereotactic radiotherapy on all sites of oligometastatic disease from 1 to 3 sites performed at most within the second cycle of systemic therapy
Control arm no ablative stereotactic radiotherapy to sites of oligometastatic disease
The procedure that is intended to be tested in the experimental arm is a stereotactic radiotherapy treatment on oligometastases up to a maximum of 3 sites with ablative dosage effective biological dose 100 Gy performed before the start of systemic therapy of I or II line at most within the second cycle of the same
It is hoped that the addition of this type of radiotherapy will increase the potential clinical benefit of the treatment in the context of colorectal cancer
The reason for this research study is to evaluate whether stereotactic radiotherapy treatment SABR in addition to the systemic chemotherapy treatment foreseen by clinical practice for low-intermediate risk oligometastatic colorectal cancer is able to
delay possible local recurrence andor distant polymetastatic progression
improve disease-free survival
reduce side effects in the short and long term
thus inducing an improvement in the quality of life of patients suffering from this type of pathology
Therefore as part of this randomized study before starting first or second line systemic therapy for his tumor the patient will be randomized to one of the following treatment arms
Experimental arm ablative stereotactic radiotherapy on all sites of oligometastatic disease from 1 to 3 sites performed at most within the second cycle of systemic therapy
Control arm no ablative stereotactic radiotherapy to sites of oligometastatic disease
The procedure that is intended to be tested in the experimental arm is a stereotactic radiotherapy treatment on oligometastases up to a maximum of 3 sites with ablative dosage effective biological dose 100 Gy performed before the start of systemic therapy of I or II line at most within the second cycle of the same
It is hoped that the addition of this type of radiotherapy will increase the potential clinical benefit of the treatment in the context of colorectal cancer
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None