Comparing Gemcitabine and Reduced-dose Combination Chemotherapy for Non-resectable Pancreatic Cancer
A Randomized Phase II Study of Gemcitabine Versus Reduced-dose Combination Chemotherapy in Fragile Patients with Non-resectable Pancreatic Cancer
This study is testing whether full-dose Gemcitabine or a lower-dose combination of Gemcitabine and Nab-Paclitaxel works better and is safer for older or frail patients with pancreatic cancer that can't be surgically removed.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 98 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Aalborg University Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Aalborg) |
| Trial ID | NCT05841420 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with non-resectable pancreatic adenocarcinoma who are unfit for full-dose chemotherapy.
Not a fit: Patients who are fit for full-dose combination chemotherapy or have other severe health issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could offer a more effective and less toxic treatment option for frail patients with non-resectable pancreatic cancer.
How similar studies have performed: Previous studies in colorectal cancer and analyses of Gemcitabine plus Nab-Paclitaxel suggest that reduced-dose combination chemotherapy may be effective, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Aalborg
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.