Gemcitabine Versus Reduced-dose Combination Chemotherapy in Fragile Patients with Non-resectable Pancreatic Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMorten Ladekarl
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 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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Gemcitabine
- Nab paclitaxel
Treatment groups
98 Participants
are divided into 2 treatment groupsSponsors and collaborators
Morten Ladekarl
Lead sponsor
Aalborg University Hospital
Sponsor institution
Aarhus University Hospital
Collaborator
Odense University Hospital
Collaborator
Herlev and Gentofte Hospital
Collaborator
Gødstrup Hospital
Collaborator
Vejle Hospital
Collaborator
Source ClinicalTrials.gov