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)
PFS (Progression Free Survival) — 1 year from end of study accrual. PFS is defined in the ITT population as the date of the randomization to the date of disease progression or date of death, whichever comes first. The date of PD is the date of scan, if progression is found on a CT scan, or date of visit at which clinical progression is found. PD at CT is defined according to RECIST version 1.1.
Trial sites (1)
Facility
City
Region
Status
Department of Oncology, Aalborg University Hospital
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.
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