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Clinical Trials in Denmark / NCT05841420
Recruiting Phase 2

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

NCT05841420 · tracked via the Priya Life Science Denmark tracker
Sponsor
Morten Ladekarl
Phase
Phase 2
Started
2023-06-12
Last updated
2025-01-29

Condition(s) studied

Pancreas CancerNon-Resectable Pancreas Carcinoma

Investigational drug(s) / intervention(s)

Gemcitabine →Nab paclitaxel →

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

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

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Age ≥ 18 years * Adenocarcinoma of the pancreas, histopathologically or cytologically verified * Non-resectable (locally advanced or metastatic) PC * Patients unfit or not candidate for full-dose combination chemotherapy * Patients eligible for full dose gemcitabine or reduced dose combination chemotherapy * Performance status (PS) ≤2 * Measurable or non-measurable disease * Adequate hematologic function defined as absolute neutrophil count (ANC) ≥1.5 x 10\^9/l and platelets count ≥100x10\^9/l within 2 weeks prior to enrollment * Adequate organ function (bilirubin ≤1.5 x UNL (Upper Normal Limit) and eGFR (estimated Glomerular Filtration Rate) \>50ml/min within 2 weeks prior to enrollment * Toxicity of prior chemotherapy, including neurotoxicity, resolved to CTCAE \<grade 2 * Oral and written informed consent must be obtained according to the local Ethics committee requirements * Fertile patients must use adequate contraceptives Exclusion Criteria: * Patients eligible for downstaging/preoperative chemotherapy followed by resection or local ablation or irradiation * Prior chemotherapy for PC (However, patients treated with adjuvant therapy with recurrence occurring more than 6 months after end of this treatment are eligible) * Concurrent, non-curatively treated malignant neoplasm other than pancreatic adenocarcinoma * Concurrent treatment with any other anti-cancer therapy * Pregnant or breast-feeding patients * Patients clearly intending to withdraw from the study if not randomized in the willing arm or patients who cannot be regularly followed up for psychological, social, familiar, or geographic reasons. * Other condition or therapy, which in the investigator's opinion may pose a risk to the patient or interfere with the study objectives. * Known allergy or intolerance to any of the drugs used in DPCG-01 (Gemcitabine, S1 or Nab-Paclitaxel)

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Department of Oncology, Aalborg University Hospital Aalborg Denmark Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05841420 on ClinicalTrials.gov ↗ ← All trials in Denmark