Estado del programa
ReclutamientoFase
No aplicableInmunoterapia previa permitida
SíEnsayo dirigido por el CRC
SíEtiquetas
MSI-H/ MMRd, MSS/ MMRpComentarios
Trial for patients with colorectal cancer that has spread to up to 3 body sites (oligometastatic) before starting first or second line systemic therapy for his tumor. In the experimental arm, patients will have the lesions ablated with stereotactic ablative radiotherapy (SABR) before systemic treatment start, or before starting the second systemic treatment cycle at the latest.
Key inclusion criteria: Controlled primary tumor is required; lesions ≤ 5 cm.
Only in Italy. Similar rationale than ERASur study
| Ubicación | Situación |
|---|---|
| Italia | |
|
IRCCS Sacro Cuore Don Calabria di Negrar Negrar, Verona 37024 |
Reclutamiento |
Criterios de inclusión
Criterios de inclusión:
* 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
Criterios de exclusión
Criterios de exclusión:
* 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
