Gemcitabine Versus Reduced-dose Combination Chemotherapy in Fragile Patients with Non-resectable Pancreatic Cancer
Recruiting now · Phase 2
Conditions studied: Pancreas Cancer, Non-Resectable Pancreas Carcinoma
In brief
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.
Key facts
- Study ID
- NCT05841420
- Run by
- Morten Ladekarl
- People needed
- 98
- Starts
- 2023-06-12
- Expected to finish
- 2025-06-01
- Last updated by the study team
- 2025-01-29
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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)
Where it is running
- Department of Oncology, Aalborg University Hospital — Aalborg, Denmark (enrolling)
Full record on ClinicalTrials.gov
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