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

Korábbi kezelés

• 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

Más betegség

• 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)

Egyéb

• 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.

• 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