Professor, M.D.
Per Pfeiffer
Department of Oncology, Odense University Hospital,
| Projekt styring | ||
| Projekt status | Open | |
| Data indsamlingsdatoer | ||
| Start | 01.06.2023 | |
| Slut | 01.06.2025 | |
The Danish Pancreas Cancer Group (DPCG)-01 trial - a randomized phase II study of gemcitabine versus reduced-dose combination chemotherapy in fragile patients with non-resectable pancreatic cancer
Short summary
The DPCG-01 trial is a national multicenter prospective randomised phase II trial aiming to investigate whether reduced dose Gemcitabine plus Nab-paclitaxel (80%) is superior to full dose Gemcitabine (100%) in patients with non-resectable pancreatic cancer, who are not candidates for full dose combination chemotherapy in first line. Primary endpoint is progression-free survival.
Rationale
According to Danish and international guidelines the best treatment option in first-line for patients with non-resectable pancreatic cancer is combination chemotherapy, whereas old and/or fragile patients can be offered monotherapy, if they are sufficiently fit for this treatment. Randomized phase III trials show improved effect of combination chemotherapy compared to monotherapy, but these trials are restricted to patients younger than 75 years in good general condition as combination chemotherapy increases toxicity. Randomized studies in metastatic colorectal cancer and a post-hoc analysis of treatment with combination chemotherapy (Gemcitabine plus Nab-Paclitaxel) in pancreatic cancer suggest that reduced dose of combination chemotherapy may be more efficient in terms of progression free survival and more feasible with less grade 3-4 adverse events compared to monotherapy in elderly and/or frail patients.
Description of the cohort
All patients eligible for inclusion are at least 18 years of age with non-resectable, pathologically verified adenocarcinoma of the pancreas, not candidate for full dose combination chemotherapy but eligible for standard dose gemcitabine. Patients are recruited from six oncological departments treating patients with pancreatic cancer in Denmark
Data and biological material
Data from the patient journal, quality of life questionnaire, blood samples, archival tissue.
Collaborating researchers and departments
Department of Oncology, Aalborg University Hospital,
- Morten Ladekarl, M.D. Prof. (sponsor)
- Louise Skau Rasmussen, M.D. PhD
Department of Oncology, Aarhus University Hospital
- Anneli Dowler Nygaard, M.D., PhD
- Britta Weber, M.D., PhD
Department of Oncology, Gødstrup Hospital
- Gabor Liposits, M.D.
Department of Oncology, Vejle Hospital
- Lise Ventzel, M.D., PhD
Department of Oncology, Herlev and Gentofte Hospital
- Inna Chen, M.D, PhD
Department of Oncology, Odense University Hospital
- Stine Winther, M.D. PhD