Chemotherapy and Surgical Resection in Patients With Hepatic Oligometastatic Adenocarcinoma of the Pancreas

Sponsor
University of Cologne
Study ID
NCT04617457
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

This is an interventional, open-label, non-randomised, multicentre, single-arm phase II clinical trial. Eligible patients with hepatic oligometastatic adenocarcinoma of the pancreas will receive neoadjuvant combination chemotherapy (liposomal irinotecan, oxaliplatin, 5-fluouracil, folinic acid (NAPOX)) in cycles of 14 days. Patients with tumour response or stable disease and a resectable primary tumour after the first 4 cycles will undergo explorative laparotomy and synchronous resection of the tumour and hepatic metastases, if feasible; these patients may receive 4 more cycles of neoadjuvant chemotherapy 2-4 weeks after the explorative laparotomy if the surgeon rated the primary tumour as non-resectable during the explorative laparotomy.

Key Dates

Start date
Oct 10, 2021
Status verified
Jan 2024
Primary completion
Dec 31, 2024
Completion
Sep 30, 2025

Study Design

Enrollment
150 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: NAPOX chemotherapy
    NAPOX chemotherapy in 14-day cycles with the four IMPs given intravenously in the following order: nal-irinotecan, oxaliplatin, folinic acid and 5-fluouracil.

Primary Outcome Measure

Overall survival after R0/R1 resection (OS-res) [ Time Frame: max 24 months follow-up ]

Central Contacts

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