NCT05841420RecruitingPhase 2
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 · Last updated 29 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 98 (estimated)
- First submitted
- 16 Mar 2023
- Start date
- 12 Jun 2023
- Primary completion date
- Jun 2025
- Lead sponsor
- Morten Ladekarl
- Diseases
- Pancreatic cancer
- NCT number
- NCT05841420
- EU CT number
- 2024-514291-41-00
- EudraCT number
- 2021-005067-52
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 98
- From 12 Jun 2023 to the primary completion date, Jun 2025
- 7 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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 illness
- 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)
Other
- 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.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (7)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Aalborg University Hospital Coordinator of this site? Confirm its status | Aalborg | Denmark | Recruiting |
| Region Midtjylland Coordinator of this site? Confirm its status | Aarhus N | Denmark | Recruiting |
| Region Hovedstaden Coordinator of this site? Confirm its status | Herlev | Denmark | Recruiting |
| Region Midtjylland Coordinator of this site? Confirm its status | Herning | Denmark | Recruiting |
| Odense University Hospital Coordinator of this site? Confirm its status | Odense C | Denmark | Recruiting |
| Region Sjaelland Coordinator of this site? Confirm its status | Roskilde | Denmark | Recruiting |
| Lillebaelt Hospital Coordinator of this site? Confirm its status | Vejle | Denmark | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.