Compares two chemotherapy treatments in frail people with inoperable pancreatic cancer
Compares gemcitabine alone with gemcitabine plus nab-paclitaxel in frail adults with pancreatic cancer.
Plain-language title generated from the registry record
Registry title: Gemcitabine Versus Reduced-dose Combination Chemotherapy in Fragile Patients with Non-resectable Pancreatic Cancer
Key facts
- Where
- Aalborg, Aarhus N, Herlev, Herning, Odense C, Roskilde, and Vejle, DenmarkSee the 7 sites
- Phase
- Phase 2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with pancreatic cancer that cannot be removed by surgery and who are not fit for full-dose combination chemotherapy.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Adenocarcinoma of the pancreas confirmed by tissue or cell tests; locally advanced or metastatic and not removable by surgery; measurable or non-measurable disease
- Earlier treatment
- No earlier chemotherapy for pancreatic cancer, except adjuvant treatment if the cancer came back more than 6 months after it ended; side effects of earlier chemotherapy must have eased to below CTCAE grade 2
- Biomarker or test result
- Blood counts and organ function within set limits in the 2 weeks before joining: ANC ≥1.5 x 10^9/l, platelets ≥100x10^9/l, bilirubin ≤1.5 x upper normal limit, eGFR >50ml/min; performance status ≤2
Main reasons for not taking part
- Can have chemotherapy to shrink the tumour before surgery, local ablation or irradiation
- Another cancer that has not been treated with intent to remove it completely
- Any other anti-cancer treatment at the same time
- Pregnant or breast-feeding
- Known allergy or intolerance to Gemcitabine, S1 or Nab-Paclitaxel
Read by machine on 9 November 2026.
Where in Denmark
- Aalborg University HospitalAalborg, DenmarkTaking people
- Region MidtjyllandAarhus N, DenmarkTaking people
- Region HovedstadenHerlev, DenmarkTaking people
- Region MidtjyllandHerning, DenmarkTaking people
- Odense University HospitalOdense C, DenmarkTaking people
- Region SjaellandRoskilde, DenmarkTaking people
- Lillebaelt HospitalVejle, DenmarkTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Morten Ladekarl
- Trial code
- NCT05841420EU 2024-514291-41-00
- Record updated
- 29 January 2025
- Original description
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.Read full original descriptionShow less
A Randomized Phase II Study of Gemcitabine Versus Reduced-dose Combination Chemotherapy in Fragile Patients with Non-resectable Pancreatic Cancer
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.
Inclusion: 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: 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; 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); 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.