Gemcitabine Versus Reduced-dose Combination Chemotherapy in Fragile Patients with Non-resectable Pancreatic Cancer
Recruiting
Phase 2
Interventional Study
Pancreas Cancer
Non-Resectable Pancreas Carcinoma
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 98 (estimated)
- Sponsor
- Morten Ladekarl · Other
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About This Trial
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 wee…
Trial Locations
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Eligibility Criteria
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…
Contacts