Gemcitabine Versus Reduced-dose Combination Chemotherapy in Fragile Patients With Non-resectable Pancreatic Cancer
Pancreas Cancer, Non-Resectable Pancreas Carcinoma
About this trial
This is an interventional treatment trial for Pancreas Cancer focused on measuring Fragile, Elderly, Palliative
Eligibility Criteria
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)
Sites / Locations
- Department of Oncology, Aalborg University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
A: "Full dose single agent strategy"
B: "Reduced dose (80%) combination-therapy strategy"
Gemcitabine monotherapy, 1000 mg/m2 weekly on days 1, 8, and 15 every 4 weeks
Nab-Paclitaxel: 100mg/m2 plus gemcitabine: 800 mg/m2 on day 1, 8 and 15 every 4 weeks