|- candidate number||27788|
|- NTR Number||NTR6645|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||24-aug-2017|
|- Secondary IDs||CCMO: NL59412.018.16 EudraCT: 2016-001332-35; Celgene: AX-CL-PANC-PI-0006859 |
|- Public Title||NABGEM study: nab-paclitaxel plus gemcitabine in patients with locally unresectable pancreatic cancer.|
|- Scientific Title||NABGEM study: A nationwide open-label multi-center prospective cohort study of nab-paclitaxel plus gemcitabine in patients with locally advanced pancreatic cancer|
|- ACRONYM||NABGEM study|
|- hypothesis||A disease control of 60% is expected and will be clinically relevant with a lower reference bound of 45%. |
|- Healt Condition(s) or Problem(s) studied||Pancreatic cancer|
|- 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||• ECOG (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.
• Patients who in the investigators’ opinion may be unwilling, unable or unlikely to comply with requirements of the study protocol
• Patients who are not willing to avoid consumption of seville oranges, grapefruit or grapefruit juice grapefruit hybrids, pommelos and exotic citrus fruits during the entire study and preferably 7 days before the first dose of study medications, due to potential CYP3A4 interaction with the study medications.
• Patient is currently being treated with drugs known to be strong inhibitors or inducers of CYP3A4 or CYP2C8, which cannot be discontinued or switched to a different medication 7 days prior to starting study treatment and for the duration of the study
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||Single arm|
|- planned startdate ||1-sep-2017|
|- planned closingdate||1-mrt-2021|
|- Target number of participants||136|
|- Interventions||chemotherapy treatment with nab-paclitaxel plus gemcitabine|
|- Primary outcome||disease controle rate|
|- Secondary outcome||Toxicity, progression-free survival, overall survival, tumor marker response, resection rate and quality of life. |
|- Timepoints||- Baseline|
- FU at 1, 3, 6, 9, 12 months after start of study treatment
- CT evaluation after 2 and 4 cycles
|- Trial web site||www.dpcg.nl/NABGEM|
|- CONTACT FOR PUBLIC QUERIES|| Marieke Walma|
|- CONTACT for SCIENTIFIC QUERIES|| Max Kerssemakers|
|- Sponsor/Initiator ||Academic Medical Center (AMC), Amsterdam|
(Source(s) of Monetary or Material Support)
|- Publications||not yet|
|- Brief summary||Rationale: 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. |
Objective: To investigate disease control after nab-paclitaxel plus gemcitabine in patients with locally advanced pancreatic cancer.
Study design: Prospective cohort study.
Study population: Patients with histological or cytological proven LAPC according to the Dutch Pancreatic Cancer Group definition.
Intervention: Nab-paclitaxel plus gemcitabine chemotherapy.
Primary endpoint: Disease control (non-progressive disease according to RECIST 1.1 criteria) after 2 cycles, confirmed after 4 cycles.
Secondary endpoint: Toxicity, progression-free survival, overall survival, tumor marker response, resection rate and quality of life.
Expected outcome: A disease control of 60% is expected and will be clinically relevant with a lower reference bound of 45%.
Statistics: A sample size of 136 patients was calculated. Descriptive statistics will be used to define the count of patients who achieved disease control. Binomial test will be used to test whether the probability of a disease control rate is different from 45%. The analysis will be performed with a two-sided alpha type 1 error of 5%.
Burden and risks associated with participation: 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.
Relevance: Each year approximately 900 patients are diagnosed with LAPC in the Netherlands. Current treatment options provide only a marginal survival benefit and FOLFIRINOX (a combination of 5-fluorouracil, leucovorin, oxaliplatin and irinotecan) treatment shows high toxicity rates. Although no comparative studies have been done, nab-paclitaxel plus gemcitabine seems to give less toxicity. Superiority of nab-paclitaxel plus gemcitabine compared to gemcitabine monotherapy has been demonstrated in patients with metastatic pancreatic cancer. In this study we want to evaluate if this regimen is of importance in patients with LAPC as well.
|- Main changes (audit trail)|
|- RECORD||24-aug-2017 - 27-aug-2017|