RecruitingPhase 2NCT05841420

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

A Randomized Phase II Study of Gemcitabine Versus Reduced-dose Combination Chemotherapy in Fragile Patients with Non-resectable Pancreatic Cancer


Sponsor

Morten Ladekarl

Enrollment

98 participants

Start Date

Jun 12, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study compares two chemotherapy approaches for people with pancreatic cancer that cannot be surgically removed and who are not well enough to tolerate standard full-dose combination chemotherapy. It compares single-agent gemcitabine (a milder option) against a lower-dose combination chemotherapy regimen. **You may be eligible if...** - You are 18 or older with confirmed pancreatic adenocarcinoma - Your cancer is locally advanced or has spread (metastatic) and cannot be surgically removed - You are not a candidate for full-dose combination chemotherapy - Your overall health and organ function allow for chemotherapy - You have not yet received chemotherapy for your pancreatic cancer **You may NOT be eligible if...** - You have already received chemotherapy for pancreatic cancer - Your organ function (kidneys, liver, bone marrow) is too impaired to safely receive any chemotherapy - You have serious uncontrolled infections or other medical problems Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGGemcitabine

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

DRUGNab paclitaxel

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


Locations(1)

Department of Oncology, Aalborg University Hospital

Aalborg, Denmark

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NCT05841420


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