Trial Outcomes & Findings for Nab-paclitaxel and Gemcitabine Hydrochloride Followed by Radiation Therapy Before Surgery in Treating Patients With Pancreatic Cancer That Can Be Removed by Surgery (NCT NCT02427841)

Last Updated: 2023-09-06

Results Overview

The R0 resection rate, measured as the percent of participants achieving R0 resection among those who initiate study drug, will be computed with 95% confidence interval. A 2-sided binomial test will be used to determine whether the R0 resection rate is significantly greater than 0.37 at 10% significance level.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

20 participants

Primary outcome timeframe

At the time of surgery

Results posted on

2023-09-06

Participant Flow

20 participants enrolled who agreed to participate in the study following completion of the informed consent process. 19 started is the number of participants who were assigned to each Arm/Group. One subject withdrew prior to treatment resulting in a total of 19 subjects enrolled and started treatment.

Participant milestones

Participant milestones
Measure	Treatment (Chemotherapy, Chemoradiation Therapy, Surgery) PRE-OPERATIVE (NEOADJUVANT) CHEMOTHERAPY: Patients receive nab-paclitaxel IV over 30 minutes and gemcitabine IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. Beginning 3-6 weeks after completion of chemotherapy, patients undergo IG-IMRT 5 days a week for 28 fractions and receive fluorouracil IV continuously on days 1-7 for 6 weeks. SURGICAL RESECTION: Patients undergo surgery 4-10 weeks after the last dose of chemoradiation. POST-OPERATIVE (ADUJUVANT) CHEMOTHERAPY: Beginning within 8-12 weeks after surgery, patients receive nab-paclitaxel IV over 30 minutes and gemcitabine IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 4 additional courses in the absence of disease progression or unacceptable toxicity. Fluorouracil: Given IV Gemcitabine: Given IV Image Guided Radiation Therapy: Undergo IG-IMRT Intensity-Modulated Radiation Therapy: Undergo IG-IMRT Laboratory Biomarker Analysis: Correlative studies Nab-paclitaxel: Given IV Therapeutic Conventional Surgery: Undergo surgery
Overall Study STARTED	19
Overall Study COMPLETED	11
Overall Study NOT COMPLETED	8

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment (Chemotherapy, Chemoradiation Therapy, Surgery) PRE-OPERATIVE (NEOADJUVANT) CHEMOTHERAPY: Patients receive nab-paclitaxel IV over 30 minutes and gemcitabine IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. Beginning 3-6 weeks after completion of chemotherapy, patients undergo IG-IMRT 5 days a week for 28 fractions and receive fluorouracil IV continuously on days 1-7 for 6 weeks. SURGICAL RESECTION: Patients undergo surgery 4-10 weeks after the last dose of chemoradiation. POST-OPERATIVE (ADUJUVANT) CHEMOTHERAPY: Beginning within 8-12 weeks after surgery, patients receive nab-paclitaxel IV over 30 minutes and gemcitabine IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 4 additional courses in the absence of disease progression or unacceptable toxicity. Fluorouracil: Given IV Gemcitabine: Given IV Image Guided Radiation Therapy: Undergo IG-IMRT Intensity-Modulated Radiation Therapy: Undergo IG-IMRT Laboratory Biomarker Analysis: Correlative studies Nab-paclitaxel: Given IV Therapeutic Conventional Surgery: Undergo surgery
Overall Study Lack of Efficacy	5
Overall Study Physician Decision	2
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Nab-paclitaxel and Gemcitabine Hydrochloride Followed by Radiation Therapy Before Surgery in Treating Patients With Pancreatic Cancer That Can Be Removed by Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (Chemotherapy, Chemoradiation Therapy, Surgery) n=19 Participants PRE-OPERATIVE (NEOADJUVANT) CHEMOTHERAPY: Patients receive nab-paclitaxel IV over 30 minutes and gemcitabine IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. Beginning 3-6 weeks after completion of chemotherapy, patients undergo IG-IMRT 5 days a week for 28 fractions and receive fluorouracil IV continuously on days 1-7 for 6 weeks. SURGICAL RESECTION: Patients undergo surgery 4-10 weeks after the last dose of chemoradiation. POST-OPERATIVE (ADUJUVANT) CHEMOTHERAPY: Beginning within 8-12 weeks after surgery, patients receive nab-paclitaxel IV over 30 minutes and gemcitabine IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 4 additional courses in the absence of disease progression or unacceptable toxicity. Fluorouracil: Given IV Gemcitabine: Given IV Image Guided Radiation Therapy: Undergo IG-IMRT Intensity-Modulated Radiation Therapy: Undergo IG-IMRT Laboratory Biomarker Analysis: Correlative studies Nab-paclitaxel: Given IV Therapeutic Conventional Surgery: Undergo surgery
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants
Age, Categorical >=65 years	14 Participants n=5 Participants
Age, Continuous	68 years n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	15 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	19 participants n=5 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0: Fully Active	3 Participants n=5 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 1: Restricted in physically strenuous activity but ambulatory and able to carry out light work	16 Participants n=5 Participants
Primary tumor site Head	11 Participants n=5 Participants
Primary tumor site Body or neck	5 Participants n=5 Participants
Primary tumor site Tail	3 Participants n=5 Participants
Greatest Tumor diameter	4.0 cm n=5 Participants
Vascular involvement Both arterial and venous	10 Participants n=5 Participants
Vascular involvement Arterial only	6 Participants n=5 Participants
Vascular involvement Venous only	1 Participants n=5 Participants
Vascular involvement No vascular involvement	2 Participants n=5 Participants
Lymph node status Positive nodes on CT scan	13 Participants n=5 Participants
Lymph node status Negative nodes on CT scan	6 Participants n=5 Participants
Serum CA 19-9	231 U/mL n=5 Participants

PRIMARY outcome

Timeframe: At the time of surgery

Population: Efficacy evaluable population is those who have received at least one administration of study drug and have at least one efficacy evaluation. Efficacy evaluable participants who fail to go onto surgery are counted as R0 failures (part of the denominator)

Outcome measures

Outcome measures
Measure	Treatment (Chemotherapy, Chemoradiation Therapy, Surgery) n=19 Participants PRE-OPERATIVE (NEOADJUVANT) CHEMOTHERAPY: Patients receive nab-paclitaxel IV over 30 minutes and gemcitabine IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. Beginning 3-6 weeks after completion of chemotherapy, patients undergo IG-IMRT 5 days a week for 28 fractions and receive fluorouracil IV continuously on days 1-7 for 6 weeks. SURGICAL RESECTION: Patients undergo surgery 4-10 weeks after the last dose of chemoradiation. POST-OPERATIVE (ADUJUVANT) CHEMOTHERAPY: Beginning within 8-12 weeks after surgery, patients receive nab-paclitaxel IV over 30 minutes and gemcitabine IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 4 additional courses in the absence of disease progression or unacceptable toxicity. Fluorouracil: Given IV Gemcitabine: Given IV Image Guided Radiation Therapy: Undergo IG-IMRT Intensity-Modulated Radiation Therapy: Undergo IG-IMRT Laboratory Biomarker Analysis: Correlative studies Nab-paclitaxel: Given IV Therapeutic Conventional Surgery: Undergo surgery
R0 Resection Rate Defined as Macroscopically Complete Tumor Removal With Negative Microscopic Surgical Margins by Pathologic Assessment	42 percentage of participants Interval 20.0 to 67.0

SECONDARY outcome

Timeframe: From the first dose of study drug(s) until 28 days after last study intervention, up to approximately 3 years, 10 months

Population: Selected adverse reactions with higher incidence (\>10%) or notable from package insert (nab-paclitaxel) during pre-operative gemcitabine \& nab-paclitaxel therapy per CTCAE terminology version 4.0. N=19

Frequency and severity of adverse events will be tabulated based on the actual treatment and the number of courses the patient receives. In particular, grade 3 and 4 toxicity rates will be computed and summarized for all patients received at least one dose of the assigned treatment.

Outcome measures

Outcome measures
Measure	Treatment (Chemotherapy, Chemoradiation Therapy, Surgery) n=19 Participants PRE-OPERATIVE (NEOADJUVANT) CHEMOTHERAPY: Patients receive nab-paclitaxel IV over 30 minutes and gemcitabine IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. Beginning 3-6 weeks after completion of chemotherapy, patients undergo IG-IMRT 5 days a week for 28 fractions and receive fluorouracil IV continuously on days 1-7 for 6 weeks. SURGICAL RESECTION: Patients undergo surgery 4-10 weeks after the last dose of chemoradiation. POST-OPERATIVE (ADUJUVANT) CHEMOTHERAPY: Beginning within 8-12 weeks after surgery, patients receive nab-paclitaxel IV over 30 minutes and gemcitabine IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 4 additional courses in the absence of disease progression or unacceptable toxicity. Fluorouracil: Given IV Gemcitabine: Given IV Image Guided Radiation Therapy: Undergo IG-IMRT Intensity-Modulated Radiation Therapy: Undergo IG-IMRT Laboratory Biomarker Analysis: Correlative studies Nab-paclitaxel: Given IV Therapeutic Conventional Surgery: Undergo surgery
Incidence of Toxicity According to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version (v) 4.0 Blood and Lymphatic system disorders	4 Adverse Events
Incidence of Toxicity According to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version (v) 4.0 Gastrointestinal disorders	24 Adverse Events
Incidence of Toxicity According to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version (v) 4.0 Hepatobiliary disorders	1 Adverse Events
Incidence of Toxicity According to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version (v) 4.0 Infections and infestations	3 Adverse Events
Incidence of Toxicity According to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version (v) 4.0 Investigations	13 Adverse Events
Incidence of Toxicity According to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version (v) 4.0 Musculoskeletal and connective tissue disorders	9 Adverse Events
Incidence of Toxicity According to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version (v) 4.0 Nervous system disorders	15 Adverse Events
Incidence of Toxicity According to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version (v) 4.0 Psychiatric disorders	2 Adverse Events
Incidence of Toxicity According to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version (v) 4.0 Respiratory, thoracic and mediastinal disorders	7 Adverse Events
Incidence of Toxicity According to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version (v) 4.0 Skin and subcutaneous tissue disorders	19 Adverse Events
Incidence of Toxicity According to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version (v) 4.0 Vascular disorders	3 Adverse Events
Incidence of Toxicity According to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version (v) 4.0 Metabolism and nutrition disorders	6 Adverse Events

SECONDARY outcome

Timeframe: From first dose of study drug until 2 years or time of death by any cause, which ever comes first. Participants are assessed every 3 months after completing study interventions.

Population: All enrolled participants receiving at least one dose of study drug(s)

The expected 2-year overall survival rate (%) will be reported with an associated 95% confidence interval for all enrolled participants (n = 19). Survival is assessed from the first dose of study drug(s) until the date of death due to any cause, up to two years. Participants known still alive at two-years will be censored at two years. Any participant lost to follow up during the two-year period will be censored on the last date known alive.

Outcome measures

Outcome measures
Measure	Treatment (Chemotherapy, Chemoradiation Therapy, Surgery) n=19 Participants PRE-OPERATIVE (NEOADJUVANT) CHEMOTHERAPY: Patients receive nab-paclitaxel IV over 30 minutes and gemcitabine IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. Beginning 3-6 weeks after completion of chemotherapy, patients undergo IG-IMRT 5 days a week for 28 fractions and receive fluorouracil IV continuously on days 1-7 for 6 weeks. SURGICAL RESECTION: Patients undergo surgery 4-10 weeks after the last dose of chemoradiation. POST-OPERATIVE (ADUJUVANT) CHEMOTHERAPY: Beginning within 8-12 weeks after surgery, patients receive nab-paclitaxel IV over 30 minutes and gemcitabine IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 4 additional courses in the absence of disease progression or unacceptable toxicity. Fluorouracil: Given IV Gemcitabine: Given IV Image Guided Radiation Therapy: Undergo IG-IMRT Intensity-Modulated Radiation Therapy: Undergo IG-IMRT Laboratory Biomarker Analysis: Correlative studies Nab-paclitaxel: Given IV Therapeutic Conventional Surgery: Undergo surgery
Overall Survival Rate Defined as the Percentage of Subjects Alive at the 2 Year Time Point	41 percentage of participants Interval 24.0 to 71.0

SECONDARY outcome

Timeframe: From first dose of study drug until 1 year or time of death by any cause, whichever comes first. Participants are assessed every 3 months after completing study interventions.

Population: All enrolled participants receiving at least one dose of study drug(s)

The expected 1-year overall survival rate (%) will be reported with an associated 95% confidence interval. Survival is assessed from the first dose of study drug(s) until the date of death due to any cause, up to one year. Participants known still alive at one-year will be censored at one year. Any participant lost to follow up during the one-year period will be censored on the last date known alive.

Outcome measures

Outcome measures
Measure	Treatment (Chemotherapy, Chemoradiation Therapy, Surgery) n=19 Participants PRE-OPERATIVE (NEOADJUVANT) CHEMOTHERAPY: Patients receive nab-paclitaxel IV over 30 minutes and gemcitabine IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. Beginning 3-6 weeks after completion of chemotherapy, patients undergo IG-IMRT 5 days a week for 28 fractions and receive fluorouracil IV continuously on days 1-7 for 6 weeks. SURGICAL RESECTION: Patients undergo surgery 4-10 weeks after the last dose of chemoradiation. POST-OPERATIVE (ADUJUVANT) CHEMOTHERAPY: Beginning within 8-12 weeks after surgery, patients receive nab-paclitaxel IV over 30 minutes and gemcitabine IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 4 additional courses in the absence of disease progression or unacceptable toxicity. Fluorouracil: Given IV Gemcitabine: Given IV Image Guided Radiation Therapy: Undergo IG-IMRT Intensity-Modulated Radiation Therapy: Undergo IG-IMRT Laboratory Biomarker Analysis: Correlative studies Nab-paclitaxel: Given IV Therapeutic Conventional Surgery: Undergo surgery
Overall Survival Rate Defined as the Percentage of Subjects Alive at the One Year Time Point	79 percentage of participants Interval 63.0 to 100.0

SECONDARY outcome

Timeframe: From time of resection until progression or death by any cause, within 1 year of resection. Participants are assessed by imaging every 3 months after completing study interventions.

Population: Study participants who receive at least one dose of study drug(s) and undergo surgical resection

The expected 1-year relapse-free survival rate (%) will be reported with an associated 95% confidence interval for those who undergo resection (n = 11). Resection-free survival is assessed from the time of resection until time of progression or death by any cause, up to one year. Participants known still alive and without progression at one-year post-resection will be censored at one year. Any participant lost to follow up during the one-year post-resection period will be censored on the last disease assessment date. Response is measured per Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1 using tumor imaging with CT. Changes in the largest diameter of tumor lesions (target lesions) and shortest diameter of malignant lymph nodes are assessed. Progression is at least 20% increase in sum of diameters of target lesions (referencing nadir sum of diameters) and an absolute increase of at least 5 mm. Presence of any new lesion is also considered progression disease.

Outcome measures

Outcome measures
Measure	Treatment (Chemotherapy, Chemoradiation Therapy, Surgery) n=11 Participants PRE-OPERATIVE (NEOADJUVANT) CHEMOTHERAPY: Patients receive nab-paclitaxel IV over 30 minutes and gemcitabine IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. Beginning 3-6 weeks after completion of chemotherapy, patients undergo IG-IMRT 5 days a week for 28 fractions and receive fluorouracil IV continuously on days 1-7 for 6 weeks. SURGICAL RESECTION: Patients undergo surgery 4-10 weeks after the last dose of chemoradiation. POST-OPERATIVE (ADUJUVANT) CHEMOTHERAPY: Beginning within 8-12 weeks after surgery, patients receive nab-paclitaxel IV over 30 minutes and gemcitabine IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 4 additional courses in the absence of disease progression or unacceptable toxicity. Fluorouracil: Given IV Gemcitabine: Given IV Image Guided Radiation Therapy: Undergo IG-IMRT Intensity-Modulated Radiation Therapy: Undergo IG-IMRT Laboratory Biomarker Analysis: Correlative studies Nab-paclitaxel: Given IV Therapeutic Conventional Surgery: Undergo surgery
Relapse-free Survival Rate Defined as the Percentage of Subjects Who Are Without Recurrence or Death at One Year From Surgical Resection of the Primary Tumor	64 percentage of participants Interval 41.0 to 99.0

SECONDARY outcome

Timeframe: From first dose of study drug(s), with assessments at Staging 1 (approximately 2 months) and Staging 2 (approximately 5 months after first dose of study drug(s)).

Population: Efficacy evaluable population, those receiving at least 1 dose of study drug(s) and having at least 1 efficacy evaluation.

The objective response rate (percentage of participants having complete response (CR) or partial response (PR)) will be computed with associated 95% confidence interval using the binomial exact method. Response is measured per RECIST 1.1 using tumor imaging with CT. Changes in the largest diameter of tumor lesions (target lesions) and shortest diameter of malignant lymphnodes are assessed. CR is the disappearance of all target lesions; any pathologic lymph nodes must show a reduction in short axis to \< 10 mm. PR is at least a 30% decrease in the sum of the diameters of target lesions using the baseline sum of diameters of target lesions as the reference level.

Outcome measures

Outcome measures
Measure	Treatment (Chemotherapy, Chemoradiation Therapy, Surgery) n=19 Participants PRE-OPERATIVE (NEOADJUVANT) CHEMOTHERAPY: Patients receive nab-paclitaxel IV over 30 minutes and gemcitabine IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. Beginning 3-6 weeks after completion of chemotherapy, patients undergo IG-IMRT 5 days a week for 28 fractions and receive fluorouracil IV continuously on days 1-7 for 6 weeks. SURGICAL RESECTION: Patients undergo surgery 4-10 weeks after the last dose of chemoradiation. POST-OPERATIVE (ADUJUVANT) CHEMOTHERAPY: Beginning within 8-12 weeks after surgery, patients receive nab-paclitaxel IV over 30 minutes and gemcitabine IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 4 additional courses in the absence of disease progression or unacceptable toxicity. Fluorouracil: Given IV Gemcitabine: Given IV Image Guided Radiation Therapy: Undergo IG-IMRT Intensity-Modulated Radiation Therapy: Undergo IG-IMRT Laboratory Biomarker Analysis: Correlative studies Nab-paclitaxel: Given IV Therapeutic Conventional Surgery: Undergo surgery
Response Rate by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 Defined as the Percent of Subjects With Complete or Partial Disease Response as Confirmed Through Tumor Imaging With Computed Tomography (CT)	21 percentage of participants Interval 6.0 to 46.0

Adverse Events

Treatment (Chemotherapy, Chemoradiation Therapy, Surgery)

Serious events: 3 serious events

Other events: 16 other events

Deaths: 13 deaths

Serious adverse events

Serious adverse events
Measure	Treatment (Chemotherapy, Chemoradiation Therapy, Surgery) n=19 participants at risk PRE-OPERATIVE (NEOADJUVANT) CHEMOTHERAPY: Patients receive nab-paclitaxel IV over 30 minutes and gemcitabine IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. Beginning 3-6 weeks after completion of chemotherapy, patients undergo IG-IMRT 5 days a week for 28 fractions and receive fluorouracil IV continuously on days 1-7 for 6 weeks. SURGICAL RESECTION: Patients undergo surgery 4-10 weeks after the last dose of chemoradiation. POST-OPERATIVE (ADUJUVANT) CHEMOTHERAPY: Beginning within 8-12 weeks after surgery, patients receive nab-paclitaxel IV over 30 minutes and gemcitabine IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 4 additional courses in the absence of disease progression or unacceptable toxicity. Fluorouracil: Given IV Gemcitabine: Given IV Image Guided Radiation Therapy: Undergo IG-IMRT Intensity-Modulated Radiation Therapy: Undergo IG-IMRT Laboratory Biomarker Analysis: Correlative studies Nab-paclitaxel: Given IV Therapeutic Conventional Surgery: Undergo surgery
Surgical and medical procedures Fascial Dehiscene	5.3% 1/19 • Number of events 1 • Adverse event data was collected at each investigator office visit from start to conclusion of subject's trial period. (up to 5 years). Utilizing NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0). Regular investigator assessment.
Infections and infestations Abdominal wall soft tissue infection	5.3% 1/19 • Number of events 1 • Adverse event data was collected at each investigator office visit from start to conclusion of subject's trial period. (up to 5 years). Utilizing NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0). Regular investigator assessment.
General disorders Intractable Nausea, vomiting, abdominal pain	5.3% 1/19 • Number of events 1 • Adverse event data was collected at each investigator office visit from start to conclusion of subject's trial period. (up to 5 years). Utilizing NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0). Regular investigator assessment.
General disorders Dehydration	5.3% 1/19 • Number of events 1 • Adverse event data was collected at each investigator office visit from start to conclusion of subject's trial period. (up to 5 years). Utilizing NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0). Regular investigator assessment.
Vascular disorders GDA Bleed/Cardiac arrest	5.3% 1/19 • Number of events 1 • Adverse event data was collected at each investigator office visit from start to conclusion of subject's trial period. (up to 5 years). Utilizing NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0). Regular investigator assessment.

Other adverse events

Other adverse events
Measure	Treatment (Chemotherapy, Chemoradiation Therapy, Surgery) n=19 participants at risk PRE-OPERATIVE (NEOADJUVANT) CHEMOTHERAPY: Patients receive nab-paclitaxel IV over 30 minutes and gemcitabine IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. Beginning 3-6 weeks after completion of chemotherapy, patients undergo IG-IMRT 5 days a week for 28 fractions and receive fluorouracil IV continuously on days 1-7 for 6 weeks. SURGICAL RESECTION: Patients undergo surgery 4-10 weeks after the last dose of chemoradiation. POST-OPERATIVE (ADUJUVANT) CHEMOTHERAPY: Beginning within 8-12 weeks after surgery, patients receive nab-paclitaxel IV over 30 minutes and gemcitabine IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 4 additional courses in the absence of disease progression or unacceptable toxicity. Fluorouracil: Given IV Gemcitabine: Given IV Image Guided Radiation Therapy: Undergo IG-IMRT Intensity-Modulated Radiation Therapy: Undergo IG-IMRT Laboratory Biomarker Analysis: Correlative studies Nab-paclitaxel: Given IV Therapeutic Conventional Surgery: Undergo surgery
Blood and lymphatic system disorders Anemia	10.5% 2/19 • Number of events 2 • Adverse event data was collected at each investigator office visit from start to conclusion of subject's trial period. (up to 5 years). Utilizing NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0). Regular investigator assessment.
Blood and lymphatic system disorders Neutropenic fever	10.5% 2/19 • Number of events 2 • Adverse event data was collected at each investigator office visit from start to conclusion of subject's trial period. (up to 5 years). Utilizing NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0). Regular investigator assessment.
Cardiac disorders Sinus tachycardia	5.3% 1/19 • Number of events 1 • Adverse event data was collected at each investigator office visit from start to conclusion of subject's trial period. (up to 5 years). Utilizing NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0). Regular investigator assessment.
Gastrointestinal disorders Nausea	42.1% 8/19 • Number of events 8 • Adverse event data was collected at each investigator office visit from start to conclusion of subject's trial period. (up to 5 years). Utilizing NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0). Regular investigator assessment.
Gastrointestinal disorders Vomiting	31.6% 6/19 • Number of events 6 • Adverse event data was collected at each investigator office visit from start to conclusion of subject's trial period. (up to 5 years). Utilizing NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0). Regular investigator assessment.
Gastrointestinal disorders Constipation	21.1% 4/19 • Number of events 4 • Adverse event data was collected at each investigator office visit from start to conclusion of subject's trial period. (up to 5 years). Utilizing NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0). Regular investigator assessment.
Gastrointestinal disorders Diarrhea	15.8% 3/19 • Number of events 3 • Adverse event data was collected at each investigator office visit from start to conclusion of subject's trial period. (up to 5 years). Utilizing NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0). Regular investigator assessment.
Gastrointestinal disorders Abdominal/flank pain	10.5% 2/19 • Number of events 2 • Adverse event data was collected at each investigator office visit from start to conclusion of subject's trial period. (up to 5 years). Utilizing NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0). Regular investigator assessment.
Gastrointestinal disorders Oral mucositis	5.3% 1/19 • Number of events 1 • Adverse event data was collected at each investigator office visit from start to conclusion of subject's trial period. (up to 5 years). Utilizing NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0). Regular investigator assessment.
Gastrointestinal disorders Dry mouth	5.3% 1/19 • Number of events 1 • Adverse event data was collected at each investigator office visit from start to conclusion of subject's trial period. (up to 5 years). Utilizing NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0). Regular investigator assessment.
Gastrointestinal disorders Dyspepsia	5.3% 1/19 • Number of events 1 • Adverse event data was collected at each investigator office visit from start to conclusion of subject's trial period. (up to 5 years). Utilizing NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0). Regular investigator assessment.
Gastrointestinal disorders Gastroesophageal reflux	5.3% 1/19 • Number of events 1 • Adverse event data was collected at each investigator office visit from start to conclusion of subject's trial period. (up to 5 years). Utilizing NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0). Regular investigator assessment.
General disorders Fatigue	42.1% 8/19 • Number of events 8 • Adverse event data was collected at each investigator office visit from start to conclusion of subject's trial period. (up to 5 years). Utilizing NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0). Regular investigator assessment.
General disorders Edema Limbs	21.1% 4/19 • Number of events 4 • Adverse event data was collected at each investigator office visit from start to conclusion of subject's trial period. (up to 5 years). Utilizing NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0). Regular investigator assessment.
General disorders Fever	21.1% 4/19 • Number of events 4 • Adverse event data was collected at each investigator office visit from start to conclusion of subject's trial period. (up to 5 years). Utilizing NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0). Regular investigator assessment.
General disorders Flu-like symptoms	21.1% 4/19 • Number of events 4 • Adverse event data was collected at each investigator office visit from start to conclusion of subject's trial period. (up to 5 years). Utilizing NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0). Regular investigator assessment.
General disorders Chills	15.8% 3/19 • Number of events 3 • Adverse event data was collected at each investigator office visit from start to conclusion of subject's trial period. (up to 5 years). Utilizing NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0). Regular investigator assessment.
General disorders Non-cardiac chest pain	10.5% 2/19 • Number of events 2 • Adverse event data was collected at each investigator office visit from start to conclusion of subject's trial period. (up to 5 years). Utilizing NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0). Regular investigator assessment.
General disorders Hot flashes	5.3% 1/19 • Number of events 1 • Adverse event data was collected at each investigator office visit from start to conclusion of subject's trial period. (up to 5 years). Utilizing NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0). Regular investigator assessment.
General disorders Insomnia	5.3% 1/19 • Number of events 1 • Adverse event data was collected at each investigator office visit from start to conclusion of subject's trial period. (up to 5 years). Utilizing NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0). Regular investigator assessment.
General disorders Lethargy	5.3% 1/19 • Number of events 1 • Adverse event data was collected at each investigator office visit from start to conclusion of subject's trial period. (up to 5 years). Utilizing NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0). Regular investigator assessment.
General disorders Localize edema	5.3% 1/19 • Number of events 1 • Adverse event data was collected at each investigator office visit from start to conclusion of subject's trial period. (up to 5 years). Utilizing NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0). Regular investigator assessment.
General disorders Generalized muscle weakness	5.3% 1/19 • Number of events 1 • Adverse event data was collected at each investigator office visit from start to conclusion of subject's trial period. (up to 5 years). Utilizing NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0). Regular investigator assessment.
General disorders Sore throat	5.3% 1/19 • Number of events 1 • Adverse event data was collected at each investigator office visit from start to conclusion of subject's trial period. (up to 5 years). Utilizing NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0). Regular investigator assessment.
General disorders Thrush	5.3% 1/19 • Number of events 1 • Adverse event data was collected at each investigator office visit from start to conclusion of subject's trial period. (up to 5 years). Utilizing NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0). Regular investigator assessment.
Hepatobiliary disorders Portal vein thrombosis	5.3% 1/19 • Number of events 1 • Adverse event data was collected at each investigator office visit from start to conclusion of subject's trial period. (up to 5 years). Utilizing NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0). Regular investigator assessment.
Infections and infestations Sepsis	5.3% 1/19 • Number of events 1 • Adverse event data was collected at each investigator office visit from start to conclusion of subject's trial period. (up to 5 years). Utilizing NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0). Regular investigator assessment.
Infections and infestations Skin infection	5.3% 1/19 • Number of events 1 • Adverse event data was collected at each investigator office visit from start to conclusion of subject's trial period. (up to 5 years). Utilizing NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0). Regular investigator assessment.
Infections and infestations Lung infection	5.3% 1/19 • Number of events 1 • Adverse event data was collected at each investigator office visit from start to conclusion of subject's trial period. (up to 5 years). Utilizing NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0). Regular investigator assessment.
Investigations Neutropenia	36.8% 7/19 • Number of events 7 • Adverse event data was collected at each investigator office visit from start to conclusion of subject's trial period. (up to 5 years). Utilizing NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0). Regular investigator assessment.
Investigations Thrombocytopenia	21.1% 4/19 • Number of events 4 • Adverse event data was collected at each investigator office visit from start to conclusion of subject's trial period. (up to 5 years). Utilizing NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0). Regular investigator assessment.
Investigations Elevated liver function tests	10.5% 2/19 • Number of events 2 • Adverse event data was collected at each investigator office visit from start to conclusion of subject's trial period. (up to 5 years). Utilizing NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0). Regular investigator assessment.
Investigations Leukopenia	10.5% 2/19 • Number of events 2 • Adverse event data was collected at each investigator office visit from start to conclusion of subject's trial period. (up to 5 years). Utilizing NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0). Regular investigator assessment.
Investigations Hypoalbuminemia	5.3% 1/19 • Number of events 1 • Adverse event data was collected at each investigator office visit from start to conclusion of subject's trial period. (up to 5 years). Utilizing NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0). Regular investigator assessment.
Investigations Elevated pancreatic enzyme	5.3% 1/19 • Number of events 1 • Adverse event data was collected at each investigator office visit from start to conclusion of subject's trial period. (up to 5 years). Utilizing NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0). Regular investigator assessment.
Metabolism and nutrition disorders Hypokalemia	15.8% 3/19 • Number of events 3 • Adverse event data was collected at each investigator office visit from start to conclusion of subject's trial period. (up to 5 years). Utilizing NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0). Regular investigator assessment.
Metabolism and nutrition disorders Anorexia	10.5% 2/19 • Number of events 2 • Adverse event data was collected at each investigator office visit from start to conclusion of subject's trial period. (up to 5 years). Utilizing NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0). Regular investigator assessment.
Metabolism and nutrition disorders Dehydration	5.3% 1/19 • Number of events 1 • Adverse event data was collected at each investigator office visit from start to conclusion of subject's trial period. (up to 5 years). Utilizing NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0). Regular investigator assessment.
Metabolism and nutrition disorders Weight loss	5.3% 1/19 • Number of events 1 • Adverse event data was collected at each investigator office visit from start to conclusion of subject's trial period. (up to 5 years). Utilizing NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0). Regular investigator assessment.
Nervous system disorders Peripheral sensory neuropathy	42.1% 8/19 • Number of events 8 • Adverse event data was collected at each investigator office visit from start to conclusion of subject's trial period. (up to 5 years). Utilizing NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0). Regular investigator assessment.
Nervous system disorders Dysgeusia	15.8% 3/19 • Number of events 3 • Adverse event data was collected at each investigator office visit from start to conclusion of subject's trial period. (up to 5 years). Utilizing NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0). Regular investigator assessment.
Nervous system disorders DIzziness	5.3% 1/19 • Number of events 1 • Adverse event data was collected at each investigator office visit from start to conclusion of subject's trial period. (up to 5 years). Utilizing NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0). Regular investigator assessment.
Nervous system disorders Encephalopathy	5.3% 1/19 • Number of events 1 • Adverse event data was collected at each investigator office visit from start to conclusion of subject's trial period. (up to 5 years). Utilizing NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0). Regular investigator assessment.
Nervous system disorders Headache	5.3% 1/19 • Number of events 1 • Adverse event data was collected at each investigator office visit from start to conclusion of subject's trial period. (up to 5 years). Utilizing NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0). Regular investigator assessment.
Nervous system disorders Transient ischemic attack	5.3% 1/19 • Number of events 1 • Adverse event data was collected at each investigator office visit from start to conclusion of subject's trial period. (up to 5 years). Utilizing NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0). Regular investigator assessment.
Psychiatric disorders Confusion	5.3% 1/19 • Number of events 1 • Adverse event data was collected at each investigator office visit from start to conclusion of subject's trial period. (up to 5 years). Utilizing NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0). Regular investigator assessment.
Psychiatric disorders Depression	5.3% 1/19 • Number of events 1 • Adverse event data was collected at each investigator office visit from start to conclusion of subject's trial period. (up to 5 years). Utilizing NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0). Regular investigator assessment.
Respiratory, thoracic and mediastinal disorders Epistaxis	21.1% 4/19 • Number of events 4 • Adverse event data was collected at each investigator office visit from start to conclusion of subject's trial period. (up to 5 years). Utilizing NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0). Regular investigator assessment.
Respiratory, thoracic and mediastinal disorders Dyspnea	15.8% 3/19 • Number of events 3 • Adverse event data was collected at each investigator office visit from start to conclusion of subject's trial period. (up to 5 years). Utilizing NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0). Regular investigator assessment.
Skin and subcutaneous tissue disorders Alopecia	47.4% 9/19 • Number of events 9 • Adverse event data was collected at each investigator office visit from start to conclusion of subject's trial period. (up to 5 years). Utilizing NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0). Regular investigator assessment.
Skin and subcutaneous tissue disorders Maculopapular rash	36.8% 7/19 • Number of events 7 • Adverse event data was collected at each investigator office visit from start to conclusion of subject's trial period. (up to 5 years). Utilizing NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0). Regular investigator assessment.
Skin and subcutaneous tissue disorders Acneiform rash	10.5% 2/19 • Number of events 2 • Adverse event data was collected at each investigator office visit from start to conclusion of subject's trial period. (up to 5 years). Utilizing NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0). Regular investigator assessment.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodyesthesia	5.3% 1/19 • Number of events 1 • Adverse event data was collected at each investigator office visit from start to conclusion of subject's trial period. (up to 5 years). Utilizing NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0). Regular investigator assessment.
Skin and subcutaneous tissue disorders Dry skin	5.3% 1/19 • Number of events 1 • Adverse event data was collected at each investigator office visit from start to conclusion of subject's trial period. (up to 5 years). Utilizing NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0). Regular investigator assessment.
Skin and subcutaneous tissue disorders Urticaria	5.3% 1/19 • Number of events 1 • Adverse event data was collected at each investigator office visit from start to conclusion of subject's trial period. (up to 5 years). Utilizing NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0). Regular investigator assessment.
Vascular disorders Hypertension	10.5% 2/19 • Number of events 2 • Adverse event data was collected at each investigator office visit from start to conclusion of subject's trial period. (up to 5 years). Utilizing NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0). Regular investigator assessment.
Vascular disorders Superficial thrombophlebitis	5.3% 1/19 • Number of events 1 • Adverse event data was collected at each investigator office visit from start to conclusion of subject's trial period. (up to 5 years). Utilizing NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0). Regular investigator assessment.
Vascular disorders Vascular access complication	5.3% 1/19 • Number of events 1 • Adverse event data was collected at each investigator office visit from start to conclusion of subject's trial period. (up to 5 years). Utilizing NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0). Regular investigator assessment.

Additional Information

Dr. Gina Vaccaro

OHSUKCI

Phone: 503-216-6300

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place