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Currently, you can access the following clinical trials being conducted worldwide:
Clinicaltrials.gov identifier NCT02723331
Recruitment Status Recruiting
First Posted March 30, 2016
Last update posted November 20, 2019
The objective of this study is to estimate the R0 resection rate in patients with Resectable Pancreatic Ductal Adenocarcinoma (R-PDAC) as well as those with Resectable Pancreatic Ductal Adenocarcinoma (BR-PDAC) independently in response to neoadjuvant sequential therapy of combination nab-paclitaxel and gemcitabine followed by stereotactic body radiotherapy (SBRT).
Patients in both cohorts will receive a total of 3 cycles of neoadjuvant combination chemotherapy of nab-paclitaxel and gemcitabine, followed by re-staging CT scan, if re-staging CT does not show evidence of metastatic disease. Patients will receive SBRT and definitive surgical resection. Subsequently, patients will receive 3 cycles of adjuvant combination chemotherapy of nab-paclitaxel and gemcitabine. Each cycle of combination chemotherapy will be a total of 4 weeks. Patients will be evaluated for response at completion of the 3 cycles of neoadjuvant combination chemotherapy with CT scans of chest, abdomen and pelvis. Patients will undergo surveillance CT scan at 3-month intervals until evidence of disease progression.
|Experimental: Nab-paclitaxel/Gemcitabine for R-PDAC
Nab-paclitaxel and gemcitabine, for R-PDAC patients enrolled in this trial, will be given in combination as neoadjuvant combination chemotherapy, followed by SBRT. This is will be followed up by surgical resection and an additional combination chemotherapy of nab-paclitaxel and gemcitabine as adjuvant chemotherapy.
Drug: Nab-paclitaxel and gemcitabine for R-PDAC Patients
Nab-paclitaxel and gemcitabine, for R-PDAC patients, will be given in combination as neoadjuvant and adjuvant chemotherapy. Nab-paclitaxel will be administered by IV infusion at a dose of 125 mg/m2 over 30 minutes on Days 1, 8, and 15 of every 28-day cycle. Gemcitabine will be administered by IV infusion, immediately after the administration of nab-paclitaxel, at a dose of 1000 mg/m2 over 30 minutes on Days 1, 8 and 15 of every 28-day cycle.
|Experimental: Nab-paclitaxel/Gemcitabine for BR-PDAC
Nab-paclitaxel and gemcitabine, for BR-PDAC patients enrolled in this trial, will be given in combination as neoadjuvant combination chemotherapy, followed by SBRT. This is will be followed up by surgical resection and an additional combination chemotherapy of nab-paclitaxel and gemcitabine as adjuvant chemotherapy.
Drug: Nab-paclitaxel and gemcitabine for BR-PDAC Patients
Nab-paclitaxel and gemcitabine, for BR-PDAC patients, will be given in combination as neoadjuvant and adjuvant chemotherapy. Nab-paclitaxel will be administered by IV infusion at a dose of 125 mg/m2 over 30 minutes on Days 1, 8, and 15 of every 28-day cycle. Gemcitabine will be administered by IV infusion, immediately after the administration of nab-paclitaxel, at a dose of 1000 mg/m2 over 30 minutes on Days 1, 8 and 15 of every 28-day cycle.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, , Learn About Clinical Studies.-->
1. Histologically confirmed resectable or borderline resectable pancreatic
2. No evidence of distant metastasis representing stage IV metastatic disease.
3. R-PDAC: No evidence of distant metastasis and tumor mass showing no extension to
superior mesenteric artery (SMA) and hepatic artery. There must be a clearly defined
fat plane between SMA and celiac axis. Patent superior mesenteric vein (SMV/portal
vein (PV) with no distortion of venous architecture.
4. BR-PDAC: defined as localized PDAC with 1 or more of the following features: a) an
interface between the primary tumor and superior mesenteric vein (SMV)-portal vein
(PV) measuring 180o or greater of the circumference of the vein wall, and/or b)
short-segment occlusion of the SMV-PV with normal vein above and below the level of
obstruction that is amenable to resection and venous reconstruction and/or c)
short-segment interface of any degree between tumor and hepatic artery with normal
artery proximal and distal to the interface that is amenable to resection and arterial
reconstruction and/or d) an interface between the tumor and SMA or celiac trunk
measuring less than 180o of the circumference of the artery wall.
5. Age > 18 years old
6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
7. Patients must have adequate bone marrow function:
- Platelets >100,000 cells/mm3
- Hemoglobin > 9.0 g/dL
- Absolute Neutrophil Count > 1,500 cells/mm3
8. Patients must have adequate liver function:
- aspartate aminotransferase (AST) and Alanine Aminotransferase (ALT) < 2.5 X upper
limit of normal
- Alkaline phosphatase < 2.5 X upper limit of normal, unless bone metastasis is
present in the absence of liver metastasis
- Total bilirubin < 1.5 mg/dL
9. Patients must have adequate renal function: creatinine 50 mL/min calculated using the Cockcroft-Gault
10. Women of childbearing potential and sexually active males must use an effective
contraception method during treatment and for three months after completing treatment.
11. Negative serum or urine β-human chorionic gonadotropin (hCG) pregnancy test at
screening for patients of childbearing potential.
12. Patients must have grade 1).
8. Patients with clinically significant cardiac disease (New York Heart Association
Classification III or IV and cardiac arrhythmias not well controlled with medication),
or myocardial infarction within the previous six months.
9. Serious, uncontrolled, concurrent infection(s) requiring antibiotics.
10. Pregnant or breastfeeding women: positive pregnancy test within 7 days of starting
11. Treatment for other carcinomas within the last five years, except cured non-melanoma
skin and treated in-situ cervical cancer.
12. Participation in any investigational drug study within 4 weeks preceding the start of
13. Patients with external biliary drains.
Contact: Chalaunda Scott 720-848-1234 firstname.lastname@example.org
United States, Arizona
Mayo Clinic Hospital
United States, Arizona
University of Arizona
United States, Colorado
University of Colorado Cancer Center
United States, New York
New York University
Academic Thoracic Oncology Medical Investigators Consortium
University of Colorado, Denver
Principal Investigator: Wells Messersmith, MD University of Colorado, Denver