Trial Outcomes & Findings for Perioperative Therapy for Resectable and Borderline-Resectable Pancreatic Adenocarcinoma With Molecular Correlates (NCT NCT02723331)
NCT ID: NCT02723331
Last Updated: 2025-07-01
Results Overview
R0 resection rates will be measured in patients with resectable PDAC and with patients with borderline-resectable PDAC, independently in response to neoadjuvant sequential therapy of combination of nab-paclitaxel and gemcitabine and SBRT, as perioperative therapy. R0 resection is determined by macroscopically complete tumor removal with negative microscopic surgical margins in the bile duct, pancreatic parenchyma, and superior mesenteric artery (SMA).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
48 participants
Primary outcome timeframe
at the time of surgery
Results posted on
2025-07-01
Participant Flow
Participant milestones
| Measure |
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.
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.
|
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.
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.
|
|---|---|---|
|
Overall Study
STARTED
|
19
|
29
|
|
Overall Study
COMPLETED
|
3
|
5
|
|
Overall Study
NOT COMPLETED
|
16
|
24
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Perioperative Therapy for Resectable and Borderline-Resectable Pancreatic Adenocarcinoma With Molecular Correlates
Baseline characteristics by cohort
| Measure |
Nab-paclitaxel and Gemcitabine for R-PDAC
n=19 Participants
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.
Nab paclitaxel: 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.
Gemcitabine: 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.
|
Nab-paclitaxel and Gemcitabine for BR-PDAC
n=29 Participants
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.
Nab paclitaxel: 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.
Gemcitabine: 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.
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
14 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Age, Continuous
|
68.35 years
STANDARD_DEVIATION 8.3 • n=5 Participants
|
68.4 years
STANDARD_DEVIATION 8.8 • n=7 Participants
|
68.4 years
STANDARD_DEVIATION 8.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
19 participants
n=5 Participants
|
29 participants
n=7 Participants
|
48 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: at the time of surgeryR0 resection rates will be measured in patients with resectable PDAC and with patients with borderline-resectable PDAC, independently in response to neoadjuvant sequential therapy of combination of nab-paclitaxel and gemcitabine and SBRT, as perioperative therapy. R0 resection is determined by macroscopically complete tumor removal with negative microscopic surgical margins in the bile duct, pancreatic parenchyma, and superior mesenteric artery (SMA).
Outcome measures
| Measure |
Nab-paclitaxel/Gemcitabine for R-PDAC
n=19 Participants
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.
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.
|
Nab-paclitaxel/Gemcitabine for BR-PDAC
n=29 Participants
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.
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.
|
|---|---|---|
|
R0 Resection Rates in Each Cohort as Measured by Macroscopically Complete Tumor Removal With Negative Microscopic Surgical Margins
|
9 participants with resectable PDAC
|
9 participants with resectable PDAC
|
SECONDARY outcome
Timeframe: 24 monthsOutcome measures
| Measure |
Nab-paclitaxel/Gemcitabine for R-PDAC
n=19 Participants
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.
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.
|
Nab-paclitaxel/Gemcitabine for BR-PDAC
n=29 Participants
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.
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.
|
|---|---|---|
|
Number of Participants With Treatment Related Adverse Events as Assessed by CTCAE v.4.03
|
19 Participants
|
29 Participants
|
SECONDARY outcome
Timeframe: Up to 74 monthsOverall survival will be assessed for all participants
Outcome measures
| Measure |
Nab-paclitaxel/Gemcitabine for R-PDAC
n=19 Participants
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.
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.
|
Nab-paclitaxel/Gemcitabine for BR-PDAC
n=29 Participants
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.
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.
|
|---|---|---|
|
Median Overall Survival
|
17.4 months
Interval 5.2 to 53.6
|
15.5 months
Interval 1.0 to 73.7
|
Adverse Events
Nab-paclitaxel/Gemcitabine for R-PDAC
Serious events: 10 serious events
Other events: 19 other events
Deaths: 18 deaths
Nab-paclitaxel/Gemcitabine for BR-PDAC
Serious events: 17 serious events
Other events: 29 other events
Deaths: 26 deaths
Serious adverse events
| Measure |
Nab-paclitaxel/Gemcitabine for R-PDAC
n=19 participants at risk
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.
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.
|
Nab-paclitaxel/Gemcitabine for BR-PDAC
n=29 participants at risk
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.
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.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
10.5%
2/19 • Number of events 2 • Up to 74 months
|
10.3%
3/29 • Number of events 3 • Up to 74 months
|
|
Renal and urinary disorders
Acute Kidney Injury
|
5.3%
1/19 • Number of events 1 • Up to 74 months
|
0.00%
0/29 • Up to 74 months
|
|
Investigations
Alanine Aminotransferase Increased
|
5.3%
1/19 • Number of events 2 • Up to 74 months
|
0.00%
0/29 • Up to 74 months
|
|
Blood and lymphatic system disorders
Anemia
|
5.3%
1/19 • Number of events 4 • Up to 74 months
|
0.00%
0/29 • Up to 74 months
|
|
Hepatobiliary disorders
Biliary Obstruction
|
10.5%
2/19 • Number of events 2 • Up to 74 months
|
3.4%
1/29 • Number of events 1 • Up to 74 months
|
|
Cardiac disorders
Chest Pain
|
5.3%
1/19 • Number of events 1 • Up to 74 months
|
0.00%
0/29 • Up to 74 months
|
|
Hepatobiliary disorders
Cholangitis
|
5.3%
1/19 • Number of events 1 • Up to 74 months
|
3.4%
1/29 • Number of events 1 • Up to 74 months
|
|
Hepatobiliary disorders
Cholecystitis
|
5.3%
1/19 • Number of events 1 • Up to 74 months
|
0.00%
0/29 • Up to 74 months
|
|
Investigations
Aspartate Aminotransferase Increased
|
5.3%
1/19 • Number of events 1 • Up to 74 months
|
0.00%
0/29 • Up to 74 months
|
|
Gastrointestinal disorders
Enterocolitis
|
5.3%
1/19 • Number of events 2 • Up to 74 months
|
0.00%
0/29 • Up to 74 months
|
|
General disorders
Fever
|
5.3%
1/19 • Number of events 1 • Up to 74 months
|
6.9%
2/29 • Number of events 3 • Up to 74 months
|
|
Infections and infestations
Gallbladder infection
|
5.3%
1/19 • Number of events 1 • Up to 74 months
|
0.00%
0/29 • Up to 74 months
|
|
General disorders
Failure to Thrive
|
5.3%
1/19 • Number of events 1 • Up to 74 months
|
0.00%
0/29 • Up to 74 months
|
|
Gastrointestinal disorders
GI infection
|
5.3%
1/19 • Number of events 1 • Up to 74 months
|
0.00%
0/29 • Up to 74 months
|
|
Investigations
Increased Creatinine
|
5.3%
1/19 • Number of events 1 • Up to 74 months
|
0.00%
0/29 • Up to 74 months
|
|
Gastrointestinal disorders
Gastric Obstruction
|
5.3%
1/19 • Number of events 1 • Up to 74 months
|
3.4%
1/29 • Number of events 1 • Up to 74 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
5.3%
1/19 • Number of events 1 • Up to 74 months
|
3.4%
1/29 • Number of events 1 • Up to 74 months
|
|
Renal and urinary disorders
Renal Calculi
|
5.3%
1/19 • Number of events 1 • Up to 74 months
|
0.00%
0/29 • Up to 74 months
|
|
Infections and infestations
Sepsis
|
5.3%
1/19 • Number of events 1 • Up to 74 months
|
3.4%
1/29 • Number of events 1 • Up to 74 months
|
|
Infections and infestations
Septic shock
|
5.3%
1/19 • Number of events 1 • Up to 74 months
|
0.00%
0/29 • Up to 74 months
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
5.3%
1/19 • Number of events 1 • Up to 74 months
|
0.00%
0/29 • Up to 74 months
|
|
Gastrointestinal disorders
Vomiting
|
5.3%
1/19 • Number of events 1 • Up to 74 months
|
3.4%
1/29 • Number of events 1 • Up to 74 months
|
|
General disorders
Back Pain
|
0.00%
0/19 • Up to 74 months
|
3.4%
1/29 • Number of events 1 • Up to 74 months
|
|
Gastrointestinal disorders
Duodenal Obstruction
|
0.00%
0/19 • Up to 74 months
|
3.4%
1/29 • Number of events 1 • Up to 74 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/19 • Up to 74 months
|
6.9%
2/29 • Number of events 2 • Up to 74 months
|
|
Hepatobiliary disorders
Encephalopathy
|
0.00%
0/19 • Up to 74 months
|
3.4%
1/29 • Number of events 1 • Up to 74 months
|
|
Endocrine disorders
Uncontrolled Diabetes
|
0.00%
0/19 • Up to 74 months
|
3.4%
1/29 • Number of events 1 • Up to 74 months
|
|
Musculoskeletal and connective tissue disorders
Generalized Muscle Weakness
|
0.00%
0/19 • Up to 74 months
|
3.4%
1/29 • Number of events 1 • Up to 74 months
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/19 • Up to 74 months
|
3.4%
1/29 • Number of events 1 • Up to 74 months
|
|
Gastrointestinal disorders
Ischemic Bowel
|
0.00%
0/19 • Up to 74 months
|
3.4%
1/29 • Number of events 1 • Up to 74 months
|
|
Investigations
Jaundice
|
0.00%
0/19 • Up to 74 months
|
3.4%
1/29 • Number of events 1 • Up to 74 months
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/19 • Up to 74 months
|
3.4%
1/29 • Number of events 1 • Up to 74 months
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/19 • Up to 74 months
|
3.4%
1/29 • Number of events 1 • Up to 74 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/19 • Up to 74 months
|
3.4%
1/29 • Number of events 1 • Up to 74 months
|
|
Injury, poisoning and procedural complications
Bleeding (post operative)
|
0.00%
0/19 • Up to 74 months
|
3.4%
1/29 • Number of events 1 • Up to 74 months
|
|
Infections and infestations
SIRS
|
0.00%
0/19 • Up to 74 months
|
3.4%
1/29 • Number of events 1 • Up to 74 months
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/19 • Up to 74 months
|
3.4%
1/29 • Number of events 1 • Up to 74 months
|
Other adverse events
| Measure |
Nab-paclitaxel/Gemcitabine for R-PDAC
n=19 participants at risk
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.
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.
|
Nab-paclitaxel/Gemcitabine for BR-PDAC
n=29 participants at risk
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.
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.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal Cramps
|
10.5%
2/19 • Number of events 3 • Up to 74 months
|
3.4%
1/29 • Number of events 1 • Up to 74 months
|
|
Gastrointestinal disorders
Abdominal Discomfort
|
0.00%
0/19 • Up to 74 months
|
6.9%
2/29 • Number of events 2 • Up to 74 months
|
|
Gastrointestinal disorders
Abdominal Distention / Bloating
|
15.8%
3/19 • Number of events 3 • Up to 74 months
|
6.9%
2/29 • Number of events 2 • Up to 74 months
|
|
Gastrointestinal disorders
Abdominal Pain
|
63.2%
12/19 • Number of events 15 • Up to 74 months
|
37.9%
11/29 • Number of events 17 • Up to 74 months
|
|
Skin and subcutaneous tissue disorders
Actinic Keratosis
|
5.3%
1/19 • Number of events 1 • Up to 74 months
|
0.00%
0/29 • Up to 74 months
|
|
Renal and urinary disorders
Acute Kidney Injury
|
5.3%
1/19 • Number of events 2 • Up to 74 months
|
0.00%
0/29 • Up to 74 months
|
|
Nervous system disorders
Agitation
|
5.3%
1/19 • Number of events 1 • Up to 74 months
|
3.4%
1/29 • Number of events 1 • Up to 74 months
|
|
Investigations
Alkaline Phosphatase Increased
|
15.8%
3/19 • Number of events 5 • Up to 74 months
|
17.2%
5/29 • Number of events 12 • Up to 74 months
|
|
Respiratory, thoracic and mediastinal disorders
Allergic Rhinitis
|
5.3%
1/19 • Number of events 1 • Up to 74 months
|
0.00%
0/29 • Up to 74 months
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
26.3%
5/19 • Number of events 7 • Up to 74 months
|
34.5%
10/29 • Number of events 10 • Up to 74 months
|
|
Investigations
Alanine Aminotransferase increased
|
36.8%
7/19 • Number of events 10 • Up to 74 months
|
17.2%
5/29 • Number of events 11 • Up to 74 months
|
|
Investigations
Anal Hemorrhage
|
5.3%
1/19 • Number of events 1 • Up to 74 months
|
0.00%
0/29 • Up to 74 months
|
|
Blood and lymphatic system disorders
Anemia
|
68.4%
13/19 • Number of events 43 • Up to 74 months
|
62.1%
18/29 • Number of events 43 • Up to 74 months
|
|
Cardiac disorders
Angina
|
5.3%
1/19 • Number of events 1 • Up to 74 months
|
0.00%
0/29 • Up to 74 months
|
|
Blood and lymphatic system disorders
Anisocytosis
|
0.00%
0/19 • Up to 74 months
|
3.4%
1/29 • Number of events 1 • Up to 74 months
|
|
General disorders
Anorectal pain
|
0.00%
0/19 • Up to 74 months
|
3.4%
1/29 • Number of events 1 • Up to 74 months
|
|
Metabolism and nutrition disorders
Anorexia
|
10.5%
2/19 • Number of events 3 • Up to 74 months
|
24.1%
7/29 • Number of events 7 • Up to 74 months
|
|
Psychiatric disorders
Anxiety
|
15.8%
3/19 • Number of events 3 • Up to 74 months
|
10.3%
3/29 • Number of events 3 • Up to 74 months
|
|
Metabolism and nutrition disorders
Decreased appetite
|
10.5%
2/19 • Number of events 2 • Up to 74 months
|
6.9%
2/29 • Number of events 2 • Up to 74 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.5%
2/19 • Number of events 2 • Up to 74 months
|
3.4%
1/29 • Number of events 1 • Up to 74 months
|
|
Gastrointestinal disorders
Ascites
|
5.3%
1/19 • Number of events 1 • Up to 74 months
|
0.00%
0/29 • Up to 74 months
|
|
Investigations
Aspartate Aminotransferase Increased
|
36.8%
7/19 • Number of events 15 • Up to 74 months
|
24.1%
7/29 • Number of events 17 • Up to 74 months
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/19 • Up to 74 months
|
3.4%
1/29 • Number of events 1 • Up to 74 months
|
|
General disorders
Back pain
|
10.5%
2/19 • Number of events 2 • Up to 74 months
|
10.3%
3/29 • Number of events 4 • Up to 74 months
|
|
Blood and lymphatic system disorders
Bilateral edema
|
21.1%
4/19 • Number of events 7 • Up to 74 months
|
37.9%
11/29 • Number of events 11 • Up to 74 months
|
|
Hepatobiliary disorders
Biliary Obstruction
|
5.3%
1/19 • Number of events 1 • Up to 74 months
|
0.00%
0/29 • Up to 74 months
|
|
Investigations
Blood Bilirubin Increased
|
5.3%
1/19 • Number of events 1 • Up to 74 months
|
10.3%
3/29 • Number of events 6 • Up to 74 months
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
5.3%
1/19 • Number of events 2 • Up to 74 months
|
6.9%
2/29 • Number of events 2 • Up to 74 months
|
|
Infections and infestations
Cellulitis
|
15.8%
3/19 • Number of events 3 • Up to 74 months
|
0.00%
0/29 • Up to 74 months
|
|
Cardiac disorders
Chest wall pain
|
0.00%
0/19 • Up to 74 months
|
3.4%
1/29 • Number of events 1 • Up to 74 months
|
|
General disorders
Chills
|
31.6%
6/19 • Number of events 6 • Up to 74 months
|
10.3%
3/29 • Number of events 4 • Up to 74 months
|
|
Hepatobiliary disorders
Cholecystitis
|
5.3%
1/19 • Number of events 1 • Up to 74 months
|
3.4%
1/29 • Number of events 1 • Up to 74 months
|
|
Investigations
Clostridium difficile colitis
|
5.3%
1/19 • Number of events 1 • Up to 74 months
|
0.00%
0/29 • Up to 74 months
|
|
Psychiatric disorders
confusion
|
10.5%
2/19 • Number of events 2 • Up to 74 months
|
0.00%
0/29 • Up to 74 months
|
|
Cardiac disorders
Congestive heart failure
|
5.3%
1/19 • Number of events 1 • Up to 74 months
|
0.00%
0/29 • Up to 74 months
|
|
Gastrointestinal disorders
Constipation
|
52.6%
10/19 • Number of events 14 • Up to 74 months
|
48.3%
14/29 • Number of events 15 • Up to 74 months
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
31.6%
6/19 • Number of events 8 • Up to 74 months
|
10.3%
3/29 • Number of events 3 • Up to 74 months
|
|
Investigations
Creatinine Increased
|
10.5%
2/19 • Number of events 3 • Up to 74 months
|
13.8%
4/29 • Number of events 7 • Up to 74 months
|
|
General disorders
Activity change
|
0.00%
0/19 • Up to 74 months
|
3.4%
1/29 • Number of events 1 • Up to 74 months
|
|
Investigations
Lymphocyte count decreased
|
15.8%
3/19 • Number of events 7 • Up to 74 months
|
20.7%
6/29 • Number of events 12 • Up to 74 months
|
|
Investigations
Thrombocytopenia
|
26.3%
5/19 • Number of events 10 • Up to 74 months
|
27.6%
8/29 • Number of events 16 • Up to 74 months
|
|
Investigations
Leukopenia
|
47.4%
9/19 • Number of events 19 • Up to 74 months
|
37.9%
11/29 • Number of events 24 • Up to 74 months
|
|
Metabolism and nutrition disorders
Dehydration
|
5.3%
1/19 • Number of events 1 • Up to 74 months
|
6.9%
2/29 • Number of events 2 • Up to 74 months
|
|
Psychiatric disorders
Depression
|
26.3%
5/19 • Number of events 5 • Up to 74 months
|
13.8%
4/29 • Number of events 4 • Up to 74 months
|
|
Endocrine disorders
Diabetes
|
0.00%
0/19 • Up to 74 months
|
3.4%
1/29 • Number of events 1 • Up to 74 months
|
|
Gastrointestinal disorders
Diarrhea
|
52.6%
10/19 • Number of events 16 • Up to 74 months
|
44.8%
13/29 • Number of events 15 • Up to 74 months
|
|
Nervous system disorders
Dizziness
|
15.8%
3/19 • Number of events 5 • Up to 74 months
|
17.2%
5/29 • Number of events 5 • Up to 74 months
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
0.00%
0/19 • Up to 74 months
|
10.3%
3/29 • Number of events 3 • Up to 74 months
|
|
Nervous system disorders
Dysgeusia
|
26.3%
5/19 • Number of events 5 • Up to 74 months
|
24.1%
7/29 • Number of events 7 • Up to 74 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
36.8%
7/19 • Number of events 9 • Up to 74 months
|
17.2%
5/29 • Number of events 8 • Up to 74 months
|
|
Gastrointestinal disorders
Enterocolitis
|
5.3%
1/19 • Number of events 2 • Up to 74 months
|
0.00%
0/29 • Up to 74 months
|
|
Gastrointestinal disorders
Epigastric pain
|
0.00%
0/19 • Up to 74 months
|
6.9%
2/29 • Number of events 2 • Up to 74 months
|
|
General disorders
Epistaxis
|
21.1%
4/19 • Number of events 4 • Up to 74 months
|
6.9%
2/29 • Number of events 2 • Up to 74 months
|
|
Skin and subcutaneous tissue disorders
Erythema
|
5.3%
1/19 • Number of events 2 • Up to 74 months
|
6.9%
2/29 • Number of events 2 • Up to 74 months
|
|
General disorders
Fatigue
|
84.2%
16/19 • Number of events 25 • Up to 74 months
|
75.9%
22/29 • Number of events 30 • Up to 74 months
|
|
General disorders
Fever
|
42.1%
8/19 • Number of events 11 • Up to 74 months
|
27.6%
8/29 • Number of events 10 • Up to 74 months
|
|
Gastrointestinal disorders
Flatulence
|
10.5%
2/19 • Number of events 2 • Up to 74 months
|
6.9%
2/29 • Number of events 2 • Up to 74 months
|
|
Investigations
Flu like Symptoms
|
15.8%
3/19 • Number of events 3 • Up to 74 months
|
6.9%
2/29 • Number of events 2 • Up to 74 months
|
|
Gastrointestinal disorders
Gastroesophageal Reflux Disease
|
10.5%
2/19 • Number of events 2 • Up to 74 months
|
10.3%
3/29 • Number of events 3 • Up to 74 months
|
|
Musculoskeletal and connective tissue disorders
Generalized Weakness
|
21.1%
4/19 • Number of events 4 • Up to 74 months
|
3.4%
1/29 • Number of events 1 • Up to 74 months
|
|
General disorders
Headache
|
26.3%
5/19 • Number of events 5 • Up to 74 months
|
13.8%
4/29 • Number of events 4 • Up to 74 months
|
|
Gastrointestinal disorders
Hemorrhoids
|
5.3%
1/19 • Number of events 1 • Up to 74 months
|
6.9%
2/29 • Number of events 2 • Up to 74 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
5.3%
1/19 • Number of events 2 • Up to 74 months
|
3.4%
1/29 • Number of events 1 • Up to 74 months
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/19 • Up to 74 months
|
10.3%
3/29 • Number of events 3 • Up to 74 months
|
|
Metabolism and nutrition disorders
Hypernatremia
|
0.00%
0/19 • Up to 74 months
|
6.9%
2/29 • Number of events 2 • Up to 74 months
|
|
Vascular disorders
Hypertension
|
5.3%
1/19 • Number of events 1 • Up to 74 months
|
13.8%
4/29 • Number of events 5 • Up to 74 months
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
26.3%
5/19 • Number of events 14 • Up to 74 months
|
20.7%
6/29 • Number of events 12 • Up to 74 months
|
|
Metabolism and nutrition disorders
hypocalcemia
|
0.00%
0/19 • Up to 74 months
|
6.9%
2/29 • Number of events 2 • Up to 74 months
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
5.3%
1/19 • Number of events 2 • Up to 74 months
|
0.00%
0/29 • Up to 74 months
|
|
Metabolism and nutrition disorders
Hypokalemia
|
15.8%
3/19 • Number of events 10 • Up to 74 months
|
24.1%
7/29 • Number of events 11 • Up to 74 months
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
10.5%
2/19 • Number of events 2 • Up to 74 months
|
3.4%
1/29 • Number of events 2 • Up to 74 months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
26.3%
5/19 • Number of events 8 • Up to 74 months
|
10.3%
3/29 • Number of events 5 • Up to 74 months
|
|
Vascular disorders
Hypotension
|
15.8%
3/19 • Number of events 3 • Up to 74 months
|
6.9%
2/29 • Number of events 2 • Up to 74 months
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/19 • Up to 74 months
|
20.7%
6/29 • Number of events 6 • Up to 74 months
|
|
Skin and subcutaneous tissue disorders
Maculopapular Rash
|
21.1%
4/19 • Number of events 8 • Up to 74 months
|
27.6%
8/29 • Number of events 12 • Up to 74 months
|
|
Skin and subcutaneous tissue disorders
Mucositis Oral
|
10.5%
2/19 • Number of events 4 • Up to 74 months
|
10.3%
3/29 • Number of events 3 • Up to 74 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
10.5%
2/19 • Number of events 2 • Up to 74 months
|
10.3%
3/29 • Number of events 5 • Up to 74 months
|
|
Gastrointestinal disorders
Nausea
|
68.4%
13/19 • Number of events 16 • Up to 74 months
|
55.2%
16/29 • Number of events 21 • Up to 74 months
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
10.5%
2/19 • Number of events 2 • Up to 74 months
|
3.4%
1/29 • Number of events 2 • Up to 74 months
|
|
Nervous system disorders
Neuropathy
|
47.4%
9/19 • Number of events 13 • Up to 74 months
|
41.4%
12/29 • Number of events 14 • Up to 74 months
|
|
Blood and lymphatic system disorders
Neutropenia
|
57.9%
11/19 • Number of events 19 • Up to 74 months
|
69.0%
20/29 • Number of events 42 • Up to 74 months
|
|
Musculoskeletal and connective tissue disorders
Pain (general)
|
26.3%
5/19 • Number of events 6 • Up to 74 months
|
24.1%
7/29 • Number of events 11 • Up to 74 months
|
|
Gastrointestinal disorders
Pancreatic Insufficiency
|
5.3%
1/19 • Number of events 1 • Up to 74 months
|
3.4%
1/29 • Number of events 1 • Up to 74 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
21.1%
4/19 • Number of events 7 • Up to 74 months
|
17.2%
5/29 • Number of events 6 • Up to 74 months
|
|
Skin and subcutaneous tissue disorders
Rash (general)
|
31.6%
6/19 • Number of events 9 • Up to 74 months
|
20.7%
6/29 • Number of events 13 • Up to 74 months
|
|
Gastrointestinal disorders
Sore Throat
|
0.00%
0/19 • Up to 74 months
|
10.3%
3/29 • Number of events 4 • Up to 74 months
|
|
Nervous system disorders
Syncope
|
0.00%
0/19 • Up to 74 months
|
10.3%
3/29 • Number of events 3 • Up to 74 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Infection
|
21.1%
4/19 • Number of events 4 • Up to 74 months
|
3.4%
1/29 • Number of events 1 • Up to 74 months
|
|
Renal and urinary disorders
Urinary tract infection
|
10.5%
2/19 • Number of events 2 • Up to 74 months
|
10.3%
3/29 • Number of events 3 • Up to 74 months
|
|
Gastrointestinal disorders
Vomiting
|
42.1%
8/19 • Number of events 9 • Up to 74 months
|
31.0%
9/29 • Number of events 13 • Up to 74 months
|
|
Metabolism and nutrition disorders
Weight Loss
|
10.5%
2/19 • Number of events 2 • Up to 74 months
|
13.8%
4/29 • Number of events 6 • Up to 74 months
|
|
Eye disorders
Blurred Vision
|
5.3%
1/19 • Number of events 1 • Up to 74 months
|
0.00%
0/29 • Up to 74 months
|
|
General disorders
Concentration Impairment
|
5.3%
1/19 • Number of events 1 • Up to 74 months
|
0.00%
0/29 • Up to 74 months
|
|
Investigations
Decreased Absolute Monocytes
|
5.3%
1/19 • Number of events 1 • Up to 74 months
|
3.4%
1/29 • Number of events 1 • Up to 74 months
|
|
Renal and urinary disorders
Decreased Urine Volume
|
5.3%
1/19 • Number of events 1 • Up to 74 months
|
0.00%
0/29 • Up to 74 months
|
|
Renal and urinary disorders
Difficulty Urinating
|
5.3%
1/19 • Number of events 1 • Up to 74 months
|
0.00%
0/29 • Up to 74 months
|
|
Gastrointestinal disorders
Distended loops of bowel
|
5.3%
1/19 • Number of events 1 • Up to 74 months
|
0.00%
0/29 • Up to 74 months
|
|
Infections and infestations
Diverticulitis
|
5.3%
1/19 • Number of events 1 • Up to 74 months
|
0.00%
0/29 • Up to 74 months
|
|
Gastrointestinal disorders
dyspepsia
|
5.3%
1/19 • Number of events 1 • Up to 74 months
|
0.00%
0/29 • Up to 74 months
|
|
Renal and urinary disorders
dysuria
|
21.1%
4/19 • Number of events 4 • Up to 74 months
|
0.00%
0/29 • Up to 74 months
|
|
Gastrointestinal disorders
Fecal incontinence
|
5.3%
1/19 • Number of events 2 • Up to 74 months
|
3.4%
1/29 • Number of events 1 • Up to 74 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
5.3%
1/19 • Number of events 1 • Up to 74 months
|
3.4%
1/29 • Number of events 1 • Up to 74 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
10.5%
2/19 • Number of events 2 • Up to 74 months
|
3.4%
1/29 • Number of events 1 • Up to 74 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
10.5%
2/19 • Number of events 2 • Up to 74 months
|
0.00%
0/29 • Up to 74 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
5.3%
1/19 • Number of events 1 • Up to 74 months
|
0.00%
0/29 • Up to 74 months
|
|
Blood and lymphatic system disorders
Pulmonary Emboli
|
5.3%
1/19 • Number of events 1 • Up to 74 months
|
0.00%
0/29 • Up to 74 months
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
5.3%
1/19 • Number of events 1 • Up to 74 months
|
3.4%
1/29 • Number of events 1 • Up to 74 months
|
|
Skin and subcutaneous tissue disorders
Skin infection
|
5.3%
1/19 • Number of events 1 • Up to 74 months
|
3.4%
1/29 • Number of events 1 • Up to 74 months
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
5.3%
1/19 • Number of events 1 • Up to 74 months
|
13.8%
4/29 • Number of events 4 • Up to 74 months
|
|
Investigations
Transaminitis
|
5.3%
1/19 • Number of events 1 • Up to 74 months
|
3.4%
1/29 • Number of events 1 • Up to 74 months
|
|
Musculoskeletal and connective tissue disorders
Tremor
|
5.3%
1/19 • Number of events 1 • Up to 74 months
|
3.4%
1/29 • Number of events 1 • Up to 74 months
|
|
Vascular disorders
Venous Thrombosis
|
5.3%
1/19 • Number of events 1 • Up to 74 months
|
6.9%
2/29 • Number of events 3 • Up to 74 months
|
|
Blood and lymphatic system disorders
Elevated INR
|
0.00%
0/19 • Up to 74 months
|
3.4%
1/29 • Number of events 2 • Up to 74 months
|
|
Gastrointestinal disorders
Blood in stool
|
0.00%
0/19 • Up to 74 months
|
3.4%
1/29 • Number of events 1 • Up to 74 months
|
|
Skin and subcutaneous tissue disorders
Nail Discooeration
|
0.00%
0/19 • Up to 74 months
|
6.9%
2/29 • Number of events 2 • Up to 74 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/19 • Up to 74 months
|
3.4%
1/29 • Number of events 1 • Up to 74 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place