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Trial Title:
Gemcitabine Versus Reduced-dose Combination Chemotherapy in Fragile Patients With Non-resectable Pancreatic Cancer
NCT ID:
NCT05841420
Condition:
Pancreas Cancer
Non-Resectable Pancreas Carcinoma
Conditions: Official terms:
Pancreatic Neoplasms
Paclitaxel
Gemcitabine
Conditions: Keywords:
Fragile
Elderly
Palliative
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Gemcitabine
Description:
Gemcitabine monotherapy, 1000 mg/m2 weekly on days 1, 8, and 15 every 4 weeks or
gemcitabine: 800 mg/m2 on day 1, 8 and 15 every 4 weeks
Arm group label:
A: "Full dose single agent strategy"
Arm group label:
B: "Reduced dose (80%) combination-therapy strategy"
Other name:
Gemzar
Intervention type:
Drug
Intervention name:
Nab paclitaxel
Description:
Nab-Paclitaxel: 100mg/m2 on day 1, 8 and 15 every 4 weeks
Arm group label:
B: "Reduced dose (80%) combination-therapy strategy"
Other name:
Abraxane
Summary:
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.
Detailed description:
According to guidelines the recommended treatment for patients with non-resectable
pancreatic cancer (PC) is combination chemotherapy, whereas old and/or fragile patients
can be offered Gemcitabine monotherapy, if they are fit for treatment. Phase III trials
show improved effect of combination chemotherapy compared to Gemcitabine, but these
trials were restricted to fit patients younger than 75 years of age, as full-dose
combination chemotherapy is more toxic.
Studies in colorectal cancer and a post-hoc analysis of Gemcitabine plus Nab-Paclitaxel
in PC suggest that reduced-dose of combination chemotherapy may be more efficient in
terms of progression-free survival and less toxic as compared to monotherapy in elderly
and/or frail patients, but reduced start-dosing of GemNab is not currently labelled.
Moreover, a recent Danish register-based study showed that more use of combination
chemotherapy at oncological departments was associated with improved outcome of patients
with PC.
Elderly and frail patients with PC are in great need of better treatment results. Hence,
a comparative study of reduced-dose combination chemotherapy is warranted and may be
practice changing.
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 PC, who are unfit
for full-dose combination chemotherapy.
The study is a national multicenter prospective randomized phase II trial, endorsed by
the Danish Pancreas Cancer Group (DPCG). 98 patients with non-resectable PC, unfit for
full-dose combination chemotherapy, but eligible for first-line chemotherapy, will be
included.
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 GemNab (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.
Criteria for 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 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Department of Oncology, Aalborg University Hospital
Address:
City:
Aalborg
Zip:
9000
Country:
Denmark
Status:
Recruiting
Contact:
Last name:
Morten Ladekarl, MD, DMSci
Phone:
+45 97660545
Email:
morten.ladekarl@rn.dk
Contact backup:
Last name:
Anja Pagh, MD, PhD
Phone:
+45 97661417
Email:
a.pagh@rn.dk
Start date:
June 12, 2023
Completion date:
June 2025
Lead sponsor:
Agency:
Morten Ladekarl
Agency class:
Other
Collaborator:
Agency:
Aarhus University Hospital
Agency class:
Other
Collaborator:
Agency:
Odense University Hospital
Agency class:
Other
Collaborator:
Agency:
Herlev and Gentofte Hospital
Agency class:
Other
Collaborator:
Agency:
Gødstrup Hospital
Agency class:
Other
Collaborator:
Agency:
Vejle Hospital
Agency class:
Other
Source:
Aalborg University Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05841420
