To investigate disease control after nab-paclitaxel plus gemcitabine in patients with locally advanced pancreatic cancer.
ID
Source
Brief title
Condition
- Gastrointestinal neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Disease control (non-progressive disease according to RECIST 1.1 criteria)
after 2 cycles, confirmed after 4 cycles.
Secondary outcome
Toxicity, progression-free survival, overall survival, tumor marker response,
resection rate and quality of life.
Background summary
In the Netherlands, around 2300 patients are diagnosed with pancreatic cancer
each year.1 It is estimated that 30 - 40 % of patients have *locally advanced
pancreatic cancer (LAPC)*: i.e. locally irresectable disease due to encasement
of vascular structures, without distance metastasis.The prognosis has barely
improved in the last decades and pancreatic cancer-related death is still
increasing. Nab-paclitaxel plus gemcitabine has shown its superiority compared
to gemcitabine monotherapy in patients with metastatic pancreatic cancer with a
median overall survival of 8.7 months versus 6.6 months. The regimen might also
benefit patients with locally advanced pancreatic cancer (LAPC) but prospective
data are lacking.
Study objective
To investigate disease control after nab-paclitaxel plus gemcitabine in
patients with locally advanced pancreatic cancer.
Study design
The study is designed as an open-label multicenter prospective cohort study.
All patients that are eligible for the study will be treated with the
combination of nab-paclitaxel plus gemcitabine. We aim to include 136 patients.
Intervention
nab-paclitaxel plus gemcitabine chemotherapy
Study burden and risks
Participation within the study includes a minimal burden, since no additional
blood samples will be taken compared to standard of care when treated with
gemcitabine monotherapy. Follow-up visits also reflect standard of care.
Patients will be asked to answer quality of life questionnaires during
treatment and follow-up.
Meibergdreef 9
Amsterdam 1105AZ
NL
Meibergdreef 9
Amsterdam 1105AZ
NL
Listed location countries
Age
Inclusion criteria
• Written informed consent according to ICH/GCP, and national/local regulations prior to any screening procedures.
• Histological or cytological confirmed diagnosis of pancreatic ductal adenocarcinoma.
• Locally advanced pancreatic cancer according to DPCG criteria (SMA, celiac axis or CHA contact >90° or SMV-PV contact <270° or occlusion)
• ECOG (WHO) performance status 0-2
• Age >= 18 years
• Adequate bone marrow and organ function as defined by the following laboratory values:
• Absolute neutrophil count (ANC) >= 1.5 *109 / L
• Hemoglobin (Hb) >= 9.0 g/dL (5.6 mmol/L)
• Platelets >= 100 *109/L
• Serum total bilirubin within <= 1.5 x ULN (upper limit of normal); or total bilirubin < 3.0 x ULN with direct bilirubin within normal range in patients with well documented Gilbert*s syndrome.
• Creatinine clearance > 50 ml / min / 1.73 m2
• AST and ALT < 2.5 ULN
Exclusion criteria
• WHO performance status >= 3
• Distant metastases on abdominal or thoracic CT scan.
• Previous surgical, local ablative, chemotherapy or radiotherapy for pancreatic cancer except for a surgical exploration with no options for resection.
• Pregnancy
• Patients who in the investigators* opinion may be unwilling, unable or unlikely to comply with requirements of the study protocol
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2016-001332-35-NL |
| CCMO | NL59412.018.16 |