Your browser doesn't support javascript.
loading
Study protocol of an open-label, single arm phase II trial investigating the efficacy, safety and quality of life of neoadjuvant chemotherapy with liposomal irinotecan combined with Oxaliplatin and 5-fluorouracil/Folinic acid followed by curative surgical resection in patients with hepatic Oligometastatic adenocarcinoma of the pancreas (HOLIPANC).
Gebauer, Florian; Damanakis, Alexander Ioannis; Popp, Felix; Quaas, Alexander; Kütting, Fabian; Lutz, Katrin; Held, Swantje; Deuß, Burkhard; Göser, Tobias; Waldschmidt, Dirk; Bruns, Christiane.
Afiliación
  • Gebauer F; Department of General, Visceral, Tumor and Transplantation Surgery, University of Cologne, Kerpener Strasse 62, 50937, Cologne, Germany. florian.gebauer@uk-koeln.de.
  • Damanakis AI; Department of General, Visceral, Tumor and Transplantation Surgery, University of Cologne, Kerpener Strasse 62, 50937, Cologne, Germany.
  • Popp F; Department of General, Visceral, Tumor and Transplantation Surgery, University of Cologne, Kerpener Strasse 62, 50937, Cologne, Germany.
  • Quaas A; Institute of Pathology, University of Cologne, Cologne, Germany.
  • Kütting F; Department of Gastroenterology, University of Cologne, Cologne, Germany.
  • Lutz K; ClinAssess GmbH, Leverkusen, Germany.
  • Held S; ClinAssess GmbH, Leverkusen, Germany.
  • Deuß B; ClinAssess GmbH, Leverkusen, Germany.
  • Göser T; Department of Gastroenterology, University of Cologne, Cologne, Germany.
  • Waldschmidt D; Department of Gastroenterology, University of Cologne, Cologne, Germany.
  • Bruns C; Department of General, Visceral, Tumor and Transplantation Surgery, University of Cologne, Kerpener Strasse 62, 50937, Cologne, Germany.
BMC Cancer ; 21(1): 1239, 2021 Nov 18.
Article en En | MEDLINE | ID: mdl-34794396
BACKGROUND: According to current guidelines, treatment of patients with hepatic oligometastasis in pancreatic cancer is not reflected and systemic chemotherapy is recommended in those patients. Retrospective data suggest beneficial outcomes in patients with hepatic oligometastasis, though prospective data from clinical trials addressing this particular patient group is not available. METHODS: In this single arm, phase-2 trial, survival data from patients receiving neoadjuvant chemotherapy followed by R0/R1 resection will be compared to historic data from patients with oligometastatic adenocarcinoma of the pancreas. The clinical trial will focus on a well-defined patient collective with metastatic load limited to the liver as target organ with a maximum of five metastases. The combination of liposomal irinotecan (nal-IRI), oxaliplatin (OX) and 5-fluouracil (5-FU)/folinic acid (FA) (nal-IRI + OX+ 5-FU/FA, NAPOX) was chosen as neoadjuvant chemotherapy; the choice was based on an ongoing clinical study in which NAPOX appeared manageable, with promising anti-tumor activity in first-line treatment of patients with metastatic pancreatic adenocarcinoma. In total 150 patients will be enrolled for this trial with an aim of 55 patients receiving a complete macroscopic synchronous tumor and metastatic resection. DISCUSSION: This is the first clinical study to prospectively evaluate the value of multimodality therapy concepts in oligometastatic pancreatic cancer. TRIAL REGISTRATION NUMBERS: EudraCT 2019-002734-37 ; NCT04617457 .
Asunto(s)
Palabras clave
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Neoplasias Pancreáticas / Calidad de Vida / Adenocarcinoma / Protocolos de Quimioterapia Combinada Antineoplásica / Terapia Neoadyuvante / Neoplasias Hepáticas Tipo de estudio: Clinical_trials / Guideline / Qualitative_research Aspecto: Patient_preference Límite: Adult / Female / Humans / Male País/Región como asunto: Europa Idioma: En Revista: BMC Cancer Asunto de la revista: NEOPLASIAS Año: 2021 Tipo del documento: Article País de afiliación: Alemania Pais de publicación: Reino Unido
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Neoplasias Pancreáticas / Calidad de Vida / Adenocarcinoma / Protocolos de Quimioterapia Combinada Antineoplásica / Terapia Neoadyuvante / Neoplasias Hepáticas Tipo de estudio: Clinical_trials / Guideline / Qualitative_research Aspecto: Patient_preference Límite: Adult / Female / Humans / Male País/Región como asunto: Europa Idioma: En Revista: BMC Cancer Asunto de la revista: NEOPLASIAS Año: 2021 Tipo del documento: Article País de afiliación: Alemania Pais de publicación: Reino Unido