Clinical trial · Interventional
Gemcitabine Versus Reduced-dose Combination Chemotherapy in Fragile Patients with Non-resectable Pancreatic Cancer
A Randomized Phase II Study of Gemcitabine Versus Reduced-dose Combination Chemotherapy in Fragile Patients with Non-resectable Pancreatic Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-Resectable Pancreas Carcinoma | Pancreatic Neoplasm | PROBABILISTIC | 0.70 |
| Pancreas Cancer | Pancreatic Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gemcitabine | Drug | Gemcitabine | ALIAS |
| Nab paclitaxel | Drug | Nab-paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- A: "Full dose single agent strategy"
- description
- Gemcitabine monotherapy, 1000 mg/m2 weekly on days 1, 8, and 15 every 4 weeks
- interventionNames
- Drug: Gemcitabine
- type
- EXPERIMENTAL
- label
- B: "Reduced dose (80%) combination-therapy strategy"
- description
- Nab-Paclitaxel: 100mg/m2 plus gemcitabine: 800 mg/m2 on day 1, 8 and 15 every 4 weeks
- interventionNames
- Drug: Gemcitabine
- Drug: Nab paclitaxel
Primary outcomes (1)
- measure
- PFS (Progression Free Survival)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (1)
- DERIVEDRasmussen LS, Winther SB, Chen IM, Weber B, Ventzel L, Liposits G, Johansen JS, Detlefsen S, Egendal I, Shim S, Christensen S, Pfeiffer P, Ladekarl M. A randomized phase II study of full dose gemcitabine versus reduced dose gemcitabine and nab-paclitaxel in vulnerable patients with non-resectable pancreatic cancer (DPCG-01). BMC Cancer. 2023 Jun 16;23(1):552. doi: 10.1186/s12885-023-11035-6. PMID 37328835