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NCT04678583

Resección anatómica de metástasis hepáticas en pacientes con cáncer colorrectal con mutaciones en los genes RAS.

Reclutando

Descripción

El ensayo ARMANI evaluará la hipótesis de si una resección anatómica (RA) mejora el resultado a largo plazo en comparación con una resección no anatómica (RNA) en pacientes sometidos a cirugía por metástasis hepáticas de cáncer colorrectal con mutación en los genes RAS (CRLM).

Evidencia de la diana molecular en cáncer colorrectal (KRAS/RAS/NRAS)

Fármaco / régimen ORR SLP (m) Fase / n Evidencia Fuente
Induction systemic treatment followed by R0/R1 resection or ablation este fármaco — — Phase 3 / n=78 2B PMID 41238984
Induction systemic treatment followed by R0/R1 resection or ablation este fármaco — — Phase 3 / n=78 2B PMID 41238984
mFOLFOXIRI + Panitumumab contexto de la diana 75% — Phase 3 / n=218 1 PMID 41505697 · 2026
mFOLFOX + Panitumumab contexto de la diana 78% — Phase 3 / n=217 1 PMID 41505697 · 2026
Sotorasib 960mg + Panitumumab contexto de la diana 30.2% — Phase 3 / n=53 1 PMID 40215429 · 2025
Sotorasib 240mg + Panitumumab contexto de la diana 7.5% — Phase 3 / n=53 1 PMID 40215429 · 2025

Criterios de Elegibilidad

Criterios de inclusión:

  • Cáncer colorrectal con mutación de RAS (KRAS o NRAS)
  • Metástasis hepáticas de cáncer colorrectal (únicas o múltiples)
  • Resección quirúrgica R0 planeada de las metástasis hepáticas (y del tumor primario, si está presente)
  • Resección hepática anatómica y no anatómica técnicamente factible
  • Pacientes de ambos sexos, edad ≥ 18 años
  • Consentimiento informado por escrito

Criterios de exclusión:

  • Metástasis extrahepáticas
  • Resección hepática escalonada planeada (por ejemplo, hepatectomía en dos etapas)
  • Diagnóstico de otro cáncer < 5 años antes de la aleatorización. Excepciones: cáncer cervical in situ tratado de forma curativa, cáncer de piel no melanoma extirpado de forma curativa
  • Posible falta de cumplimiento
  • Adicción u otras enfermedades que impidan a la persona en cuestión evaluar la naturaleza y el alcance del ensayo clínico y sus posibles consecuencias

Información del Ensayo

NCT04678583
Reclutando
Sin fase definida
240 participantes
Ene 2021

Ubicaciones37

Germany (37)
Intestinal Center West Middle Franconia, ANregiomed Clinic Ansbach
Ansbach
Clinic for General, Vizeral and Transplant Surgery, Augsburg University Hospital
Augsburg
Department of General, Visceral and Vascular Surgery, Charité, University Medicine Berlin, Campus Benjamin Franklin Berlin
Berlin
Clinic and Polyclinic for General, Visceral, Thoracic and Vascular Surgery, University Hospital Bonn
Bonn
Surgical Clinic, Municipal Hospital Braunschweig gGmbH
Braunschweig
Cancer Center, Helios Amper-Hospital Dachau
Dachau
Surgical Clinic, Dortmund Hospital
Dortmund
Clinic for General and Visceral Surgery, Municipal Hospital Dresden
Dresden
Department of Gastrointestinal-, Thoracic and Vascular Surgery University Hospital Carl Gustav Carus Technische Universität Dresden
Dresden
Clinic for General, Visceral and Pediatric Surgery, University Hospital Düsseldorf
Düsseldorf
Surgical Clinic, University Hospital Erlangen
Erlangen
Clinic for General, Visceral and Transplant Surgery, University Hospital Frankfurt, Goethe University Frankfurt am Main
Frankfurt
Department for General and Visceral Surgery, Medical Center, University of Freiburg, Faculty of Medicine, University of Freiburg
Freiburg im Breisgau
JLU Gießen, Department for General, Visceral, Thoracic and Transplant Surgery
Giessen
Clinic for General, Visceral and Pediatric Surgery, University Medical Center Göttingen, Georg-August-University
Göttingen
Clinic and Polyclinic for General Surgery, Department of Gastrointestinal, Thoracic and Vascular Surgery, University Greifswald, University Hospital Greifswald
Greifswald
University Hospital and Polyclinic for Visceral, Vascular and Endocrine Surgery, University Hospital Halle (Saale)
Halle
Center for Surgical Medicine - Clinic and Polyclinic for General, Visceral and Thoracic Surgery, University Hospital Hamburg-Eppendorf
Hamburg
Department of Liver, Bile Duct and Pancreas Surgery, University Department of surgery, Asklepios Klinik Barmbek
Hamburg
Clinic for General, Visceral and Minimally Invasive Surgery, KRH Clinic Siloah, Hannover
Hanover
Medizinische Hochschule Hannover, Department of General, Visceral and Transplant Surgery
Hanover
Department of General, Visceral and Transplantation Surgery, University of Heidelberg
Heidelberg
General Visceral and Vascular Surgery, Jena University Medical Center
Jena
Clinic for Surgery, University Hospital Schleswig-Holstein Lübeck Campus
Lübeck
University Department of General, Visceral, Vascular and Transplant Surgery, Faculty of Medicine, Otto von Guericke University Magdeburg
Magdeburg
Clinic for General, Visceral and Transplantation Surgery, University Medical Center of the Johannes Gutenberg-University Mainz
Mainz
Department of Surgery at the University Medical Center Mannheim, Medical Faculty Mannheim, Heidelberg University
Mannheim
Clinic for Visceral, Thoracic and Vascular Surgery, University Hospital Giessen and Marburg
Marburg
Department Hepato-Pancreato-Biliary Surgery, Barmherzige Brüder gGmbH of the Hospital Barmherzige Brüder Munich
München
Department of Surgery, University Hospital rechts der Isar
München
LMU Munich Hospital, Clinic for General, Visceral and Transplant Surgery
Munich
Clinic for General, Visceral and Transplant Surgery, University of Münster
Münster
University Hospital for General and Visceral Surgery, Oldenburg Hospital
Oldenburg
Department of General, Visceral and Transplant Surgery, University of Tübingen, Comprehensive Cancer Center
Tübingen
Clinic for General and Visceral Surgery, Ulm University Medical Center
Ulm
General and Visceral Surgery, Helios University Medical Center Wuppertal, University Witten/Herdecke
Wuppertal
Department for General, Visceral, Transplant, Vascular and Pediatric Surgery, Julius-Maximilian-University Würzburg, University Hospital Würzburg
Würzburg

Fuente Oficial

Ver en ClinicalTrials.gov