Actively Recruiting
Gemcitabine Versus Reduced-dose Combination Chemotherapy in Fragile Patients with Non-resectable Pancreatic Cancer
Led by Morten Ladekarl · Updated on 2025-01-29
98
Participants Needed
1
Research Sites
102 weeks
Total Duration
On this page
Sponsors
M
Morten Ladekarl
Lead Sponsor
A
Aarhus University Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Gemcitabine Versus Reduced-dose Combination Chemotherapy in Fragile Patients with Non-resectable Pancreatic Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Histologically or cytologically confirmed adenocarcinoma of the pancreas
- Non-resectable pancreatic cancer (locally advanced or metastatic)
- Not suitable for full-dose combination chemotherapy
- Eligible for either full-dose Gemcitabine or reduced-dose combination chemotherapy
- Performance status of 2 or less
- Measurable or non-measurable disease
- Adequate blood function with absolute neutrophil count ≥ 1.5 x 10^9/l and platelets ≥ 100 x 10^9/l within 2 weeks prior to enrollment
- Adequate organ function with bilirubin ≤ 1.5 times upper normal limit and estimated glomerular filtration rate > 50 ml/min within 2 weeks prior to enrollment
- Side effects from previous chemotherapy resolved to less than grade 2
- Provided oral and written informed consent
- Fertile patients agree to use effective contraception
You will not qualify if you...
- Eligible for downstaging or preoperative chemotherapy followed by surgery or local treatment
- Prior chemotherapy for pancreatic cancer, except adjuvant therapy with recurrence more than 6 months after treatment ends
- Current active cancer other than pancreatic adenocarcinoma not treated with curative intent
- Receiving any other anti-cancer treatment concurrently
- Pregnant or breastfeeding
- Intending to withdraw if not assigned preferred treatment arm or unable to attend regular follow-up due to psychological, social, family, or geographic reasons
- Any condition or therapy that may pose risk or interfere with study objectives
- Known allergy or intolerance to study drugs (Gemcitabine, S1 or Nab-Paclitaxel)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Department of Oncology, Aalborg University Hospital
Aalborg, Denmark, 9000
Actively Recruiting
Research Team
M
Morten Ladekarl, Professor
CONTACT
L
Louise Rasmussen, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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