Investigating a new combination of chemotherapy (nab-paclitaxel and gemcitabine) for patients with unresectable pancreatic cancer without metastasis.

A nationwide open-label multi-center prospective cohort study of nab-paclitaxel plus gemcitabine in patients with locally advanced pancreatic cancer - NABGEM prospective cohort study in LAPC

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-001332-35-NL

Enrollment

Unknown

Registered

2017-01-26

Start date

2017-03-20

Completion date

Unknown

Last updated

2017-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Locally advanced pancreatic adenocarcinoma without distant metastases, according to the Dutch Pancreatic Cancer Group (DPCG) definition.

Interventions

Trade Name: Abraxane Pharmaceutical Form: Powder for suspension for injection INN or Proposed INN: PACLITAXEL CAS Number: 33069-62-4 Concentration unit: mg/m2 milligram(s)/square meter Concentration t

Eligibility

Sex/Gender

All

Inclusion criteria

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 50 ml / min / 1.73 m2 • AST and ALT =65 years) yes F.1.3.1 Number of subjects for this age range 56

Exclusion criteria

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 outcomes

Primary

Measure	Time frame
Primary end point(s): Disease control: The percentage of patients who had a complete response, partial response, or stable disease according to RECIST 1.1 measured after 2 cycles of nab-paclitaxel plus gemcitabine and confirmed at restaging after 4 cycles of nab-paclitaxel plus gemcitabine.;Timepoint(s) of evaluation of this end point: After 2 cycles of nab-paclitaxel plus gemcitabine and after 4 cycles: 2 months and 4 months respectively.;Main Objective: To investigate disease control after nab-paclitaxel plus gemcitabine in patients with locally advanced pancreatic cancer. ;Secondary Objective: To investigate toxicity, progression-free survival, overall survival, tumor marker response, resection rate and quality of life after nab-paclitaxel plus gemcitabine in patients with locally advanced pancreatic cancer	—

Measure

Time frame

Primary end point(s): Disease control: The percentage of patients who had a complete response, partial response, or stable disease according to RECIST 1.1 measured after 2 cycles of nab-paclitaxel plus gemcitabine and confirmed at restaging after 4 cycles of nab-paclitaxel plus gemcitabine.;Timepoint(s) of evaluation of this end point: After 2 cycles of nab-paclitaxel plus gemcitabine and after 4 cycles: 2 months and 4 months respectively.;Main Objective: To investigate disease control after nab-paclitaxel plus gemcitabine in patients with locally advanced pancreatic cancer. ;Secondary Objective: To investigate toxicity, progression-free survival, overall survival, tumor marker response, resection rate and quality of life after nab-paclitaxel plus gemcitabine in patients with locally advanced pancreatic cancer

—

Secondary

Measure	Time frame
Secondary end point(s): Toxicity according to the NCI CTC Version 4.0 grading system Median overall survival Progression free survival CA19-9 and CEA response Resection rate and margin-free resection Quality of life;Timepoint(s) of evaluation of this end point: Follow-up: 1, 3, 6, 9, 12 months.	—

Countries

Netherlands

Contacts

Public ContactMarieke Walma - G4 118

Academic Medical Center Amsterdam

m.s.walma@amc.uva.nl

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026