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).
Adenocarcinoma
/ drug therapy
Adult
Antineoplastic Combined Chemotherapy Protocols
/ adverse effects
Chemotherapy, Adjuvant
/ adverse effects
Female
Fluorouracil
/ administration & dosage
Germany
Humans
Irinotecan
/ administration & dosage
Leucovorin
/ administration & dosage
Liposomes
Liver Neoplasms
/ mortality
Male
Neoadjuvant Therapy
/ adverse effects
Oxaliplatin
/ administration & dosage
Pancreatic Neoplasms
/ drug therapy
Progression-Free Survival
Quality of Life
Chemotherapy
Clinical trials
Liver metastasis
Pancreatic cancer
Pancreatic surgery
Journal
BMC cancer
ISSN: 1471-2407
Titre abrégé: BMC Cancer
Pays: England
ID NLM: 100967800
Informations de publication
Date de publication:
18 Nov 2021
18 Nov 2021
Historique:
received:
23
07
2021
accepted:
04
11
2021
entrez:
19
11
2021
pubmed:
20
11
2021
medline:
22
2
2022
Statut:
epublish
Résumé
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. 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. This is the first clinical study to prospectively evaluate the value of multimodality therapy concepts in oligometastatic pancreatic cancer. EudraCT 2019-002734-37 ; NCT04617457 .
Sections du résumé
BACKGROUND
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
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
CONCLUSIONS
This is the first clinical study to prospectively evaluate the value of multimodality therapy concepts in oligometastatic pancreatic cancer.
TRIAL REGISTRATION NUMBERS
BACKGROUND
EudraCT 2019-002734-37 ; NCT04617457 .
Identifiants
pubmed: 34794396
doi: 10.1186/s12885-021-08966-3
pii: 10.1186/s12885-021-08966-3
pmc: PMC8600696
doi:
Substances chimiques
Liposomes
0
Oxaliplatin
04ZR38536J
Irinotecan
7673326042
Leucovorin
Q573I9DVLP
Fluorouracil
U3P01618RT
Banques de données
ClinicalTrials.gov
['NCT04617457']
Types de publication
Clinical Trial Protocol
Clinical Trial, Phase II
Journal Article
Multicenter Study
Langues
eng
Sous-ensembles de citation
IM
Pagination
1239Informations de copyright
© 2021. The Author(s).
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