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Trial Title:
Low and Intermediate Risk oliGometastatic coloREctal cancEr patieNts Treated With Stereotactic ABlative Radiotherapy
NCT ID:
NCT06310564
Condition:
Colorectal Cancer
Conditions: Official terms:
Colorectal Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
SABR
Description:
A biological effective dose (BED) ≥125 Gy10 should be administered when constraints to
the organs at risk (OARs) are respected [10]; if not possible, a BED schedule no lower
than 100 Gy10 should be administered. In compliance with these instructions, treatment
schedules, total dose and fractionation will be prescribed according to the clinical
practice of each participating Center. The constraints for the organs at risk will be
respected according to the available data.
In any case, biological effective dose (BED) ≥125 Gy10 should be administered when
constraints to the organs at risk (OARs) are respected; if not possible, a BED schedule
no lower than 100 Gy10 should be administered.
SABR will be administered before systemic treatment start, or before starting the second
systemic treatment cycle at the latest.
Arm group label:
stereotactic ablative radiotherapy (SABR)
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 and/or 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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Age ≥18 years
- Histologically confirmed CRC
- Low and intermediate risk oligometastatic colorectal cancer with 1 to 3 metastases,
candidate to I or II line systemic treatment (Low risk: 1 to 3 metastases and
cumulative tumor volume smaller than 10 cm3; Intermediate risk: 1 to 3 metastases
and cumulative tumor volume bigger than 10 cm3).
- Controlled primary tumor regardless of primary surgery or primary systemic treatment
- ECOG/WHO 0-2
- Life expectancy > 6 months
- Lesions ≤ 5 cm
- Adequate organ function for the planned treatment according to local guidelines
- For patients with liver metastases: no cirrhosis or hepatitis, and evidence of
adequate hepatic function (Total bilirubin level < 1.5 x institutional ULN; ALT and
AST levels < 3.0 x institutional ULN, GGT and alkaline phosphatase levels < 3.0 x
institutional ULN; INR and APTT levels < 1.5 x institutional ULN, Albumin > 2.5
mg/dL)
- For patients with liver metastases: unresectable liver metastases (assessed by a
surgeon, preferably hepatobiliary) or refusal of liver surgery before study
screening.
- If childbearing potential, willing to use an effective form of contraception
throughout the duration of the study
- Signed informed consent and willingness to follow the trial procedures
Exclusion Criteria:
- Age < 18 years
- Brain metastases
- Having more than 3 metastases
- Malignant pleural effusion or ascites
- Unable to undergo imaging by either CT scan or MRI
- Evidence of any other medical conditions (such as psychiatric illness, infectious
diseases, neurological conditions, physical examination or laboratory findings) that
may interfere with the planned treatment or affect patient compliance.
- Pregnancy or breast-feeding
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
IRCCS Sacro Cuore Don Calabria di Negrar
Address:
City:
Negrar
Zip:
37024
Country:
Italy
Contact:
Last name:
Luca Nicosia, Doctor
Phone:
+39(0)456014800
Email:
luca.nicosia@sacrocuore.it
Start date:
April 2024
Completion date:
April 2031
Lead sponsor:
Agency:
IRCCS Sacro Cuore Don Calabria di Negrar
Agency class:
Other
Source:
IRCCS Sacro Cuore Don Calabria di Negrar
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06310564