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RECRUITINGPhase 2INTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 - your organs (liver, kidneys, etc.) are working well enough based on blood tests (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 willing to sign a consent form must be obtained according to the local Ethics committee requirements - Fertile patients must use adequate contraceptives Who Should NOT Join This Trial: - 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) Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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)

Treatments Being Tested

DRUG

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

DRUG

Nab paclitaxel

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

Locations (1)

Department of Oncology, Aalborg University Hospital
Aalborg, Denmark