Trasplante hepático comparado con quimioterapia en pacientes con cáncer colorrectal

Estado del programa

Reclutamiento

Fase

No aplicable

Inmunoterapia previa permitida

No

Ensayo dirigido por el CRC

Drogas

Quimioterapia

Etiquetas

MSI-H/ MMRd, MSS/ MMRp
Ubicación Situación
Noruega
Hospital Universitario de Oslo
Oslo
Reclutamiento

Contactos

Dr. Magnus Smedman
Contacto
23026600 torha@ous-hf.no
Maria Gjerde
Contacto
+4723070000 mgjerde@ous-hf.no

Criterios de inclusión

Criterios de inclusión:

Histologically verified adenocarcinoma in colon/rectum.
Liver metastases, not amenable to liver resection
No signs of extra hepatic metastatic disease or local recurrence according to PET/CT scan within 6 weeks prior to the faculty meeting at the transplant unit, except patients may have resectable lung lesions all < 15mm.
No signs of extra hepatic metastatic disease on CT or MRI thorax/abdomen/pelvis within 6 weeks prior to the faculty meeting at the transplant unit, except resectable lung lesions all < 15mm.
No signs of extra hepatic metastatic disease on PET/CT within 6 weeks prior to the faculty meeting at the transplant unit, except patients may have resectable lung lesions all < 15mm Good performance status, ECOG 0 or 1. Satisfactory blood tests Hb >10g/dl, neutrophiles >1.0 (after any G-CSF), TRC >75, Bilirubin<1.5 x upper normal level, ASAT, ALAT<5 x upper normal level, Creatinine 10% the last 6 months
Patient BMI > 30
Previous resection of local relapse or non-hepatic metastasis within the last 2 years or resection of pulmonary or liver hilus lymph node metastases the last year.
Previous diagnosed bone or CNS metastatic disease or thoracic or abdominal metastatic lymph nodes.
Previous diagnosed cancer mammae or malignant melanoma.
Non resected or palliative resection of primary CRC tumor.
Liver metastases affecting the diaphragm determined by CT-scan and/or ultrasound examination.
Liver lesion>10cm
Three negative prognostic factors at time of randomization (CEA>80, less than 2 years from diagnosis, diameter of largest liver lesion >5.5cm).
Any reason why, in the opinion of the investigator, the patient should not participate.

NCT ID

NCT03494946

Fecha en que se añadió el juicio

2018-04-11

Fecha de actualización

2024-02-06