Overview

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

Status:
Not yet recruiting

Trial end date:
2025-06-01

Target enrollment:

Participant gender:

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.

Phase:

Phase 2

Details

Lead Sponsor:

Morten Ladekarl

Collaborators:

Aarhus University Hospital
Gødstrup Hospital
Herlev and Gentofte Hospital
Odense University Hospital
Vejle Hospital

Treatments:

Gemcitabine
Paclitaxel