Comparing Gemcitabine and Reduced-dose Combination Chemotherapy for Non-resectable Pancreatic Cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to evaluate the effectiveness and safety of full-dose Gemcitabine versus reduced-dose combination chemotherapy in patients with non-resectable pancreatic cancer who are not suitable for full-dose treatment. Participants will be randomly assigned to receive either full-dose Gemcitabine or a reduced-dose combination of Gemcitabine and Nab-Paclitaxel. The study will assess progression-free survival, overall survival, response rates, toxicity, and quality of life. This national multicenter trial seeks to provide better treatment options for elderly and frail patients with pancreatic cancer.

Why it matters

Who can join: the full rules

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)

Where it's running

• Department of Oncology, Aalborg University Hospital
  Aalborg, Denmark Recruiting

Study contacts

• Principal investigator: Morten Ladekarl, Professor — Aalborg Universitets Hospital, Department of Oncology
• Study coordinator: Morten Ladekarl, Professor
• Email: morten.ladekarl@rn.dk
• Phone: 0045+61399326

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.