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Gemcitabine Versus Reduced-dose Combination Chemotherapy in Fragile Patients with Non-resectable Pancreatic Cancer

NCT05841420 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 98

Last updated 2025-01-29

No results posted yet for this study

Summary

The aim of the study is to compare the efficacy and toxicity of full-dose Gemcitabine and reduced-dose combination chemotherapy in patients with non-resectable pancreatic cancer, who are unfit for full-dose combination chemotherapy.

The patients will be equally randomized to arm A or arm B:

Arm A: Full-dose single agent treatment with Gemcitabine 1000 mg/m2 weekly on days 1, 8,and 15 every 4 weeks.

Arm B: Reduced-dose (80%) combination-treatment with Gemcitabine plus Nab-Paclitaxel (Gemcitabine: 800 mg/m2 plus Nab-Paclitaxel: 100 mg/m2 on day 1, 8 and 15 every 4 weeks)

Progression-free survival, overall survival and response rate will be estimated for each group, as well as toxicity and quality of life will be prospectively registered.

Conditions

  • Pancreas Cancer
  • Non-Resectable Pancreas Carcinoma

Interventions

DRUG

Gemcitabine

Gemcitabine monotherapy, 1000 mg/m2 weekly on days 1, 8, and 15 every 4 weeks or gemcitabine: 800 mg/m2 on day 1, 8 and 15 every 4 weeks

DRUG

Nab paclitaxel

Nab-Paclitaxel: 100mg/m2 on day 1, 8 and 15 every 4 weeks

Sponsors & Collaborators

  • Aarhus University Hospital

    collaborator OTHER

  • Odense University Hospital

    collaborator OTHER

  • Herlev and Gentofte Hospital

    collaborator OTHER

  • Gødstrup Hospital

    collaborator OTHER

  • Vejle Hospital

    collaborator OTHER

  • Morten Ladekarl

    lead OTHER

Principal Investigators

  • Morten Ladekarl, Professor · Aalborg Universitets Hospital, Department of Oncology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-12
Primary Completion
2025-06-30
Completion
2025-06-30

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Drugs

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 NCT05841420 on ClinicalTrials.gov