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Second Line Treatment With Nal-IRI and S1 in Pancreatic Cancer

NCT03986294 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 122

Last updated 2021-01-15

No results posted yet for this study

Summary

To determine the optimal second line treatment strategy in patients with metastatic pancreatic cancer who underwent a therapy with gemcitabine.

Conditions

Interventions

DRUG

S1 + Nal-IRI

S-1 will be given for 14 consecutive days, twice daily, followed by 2 weeks rest. Nal-IRI will be administered as an intravenous infusion on day 1 and 15. Courses of treatment will be repeated every 4 weeks.

DRUG

Nal-IRI+Leucovorin+5-FU

Nal-IRI 80 mg/m2 will be administered first, followed by LV 400 mg/m2, followed by 5-FU 2400 mg/m2 as an IV infusion over 46-hours on days 1-3. Each cycle consists of 14 days. Courses of treatment will be repeated every 2 weeks.

Sponsors & Collaborators

  • UMC Utrecht

    collaborator OTHER

  • Isala

    collaborator OTHER

  • Maastricht University Medical Center

    collaborator OTHER

  • Vall de Hebron, Barcelona, Spain

    collaborator UNKNOWN

  • University Hospital Verona, Italy

    collaborator UNKNOWN

  • Odense University Hospital

    collaborator OTHER

  • Medical University of Vienna

    collaborator OTHER

  • Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

    lead OTHER

Principal Investigators

  • J W Wilmink, MD, PhD · Ademic Medical Center Amsterdam

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-01
Primary Completion
2022-01-01
Completion
2022-01-01

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03986294 on ClinicalTrials.gov