Trial Outcomes & Findings for Gemcitabine/Nab-Paclitaxel With HIGRT in Resectable Pancreatic Cancer (NCT NCT02318095)

Last Updated: 2023-10-26

Results Overview

The neoadjuvant regimen will be considered feasible if (a) the trial can accrue 25 patients in no more than 3 years and (b) if at least 17 of the 25 patients adhere to the neoadjuvant regimen and c) the acute grade 3+ non-hematologic acute toxicity is less than 50% (exclusing fatigue and alopecia).

Recruitment status

COMPLETED

Study phase

Target enrollment

40 participants

Primary outcome timeframe

approximately 6 months

Results posted on

2023-10-26

Participant Flow

Participant milestones

Participant milestones
Measure	Chemotherapy/Radiation/Surgery This is a single arm prospective study. All eligible subjects will receive 2 cycles of neoadjuvant Gemcitabine/nab-Paclitaxel, followed by hypofractionated radiation therapy followed by surgical resection. Subjects may receive adjuvant chemotherapy post surgical resection at the clinical discretion of the medical oncologist. Radiation therapy: 5 fractions of hypofractionated IGRT or IMRT at 5Gy per fraction will be delivered before surgery. Restaging will be completed post radiation therap
Overall Study STARTED	40
Overall Study COMPLETED	39
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Chemotherapy/Radiation/Surgery This is a single arm prospective study. All eligible subjects will receive 2 cycles of neoadjuvant Gemcitabine/nab-Paclitaxel, followed by hypofractionated radiation therapy followed by surgical resection. Subjects may receive adjuvant chemotherapy post surgical resection at the clinical discretion of the medical oncologist. Radiation therapy: 5 fractions of hypofractionated IGRT or IMRT at 5Gy per fraction will be delivered before surgery. Restaging will be completed post radiation therap
Overall Study Adverse Event	1

Baseline Characteristics

Gemcitabine/Nab-Paclitaxel With HIGRT in Resectable Pancreatic Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Chemotherapy/Radiation/Surgery n=40 Participants Gemcitabine/nab-Paclitaxel: Prospective, single arm study ; eligible subjects will recieve 2 cycles of neoadjuvant Gemcitabine/nab-Paclitaxel. All chemotherapy administered to study subjects is standard of care. The chemotherapy combination, gemcitabine/nab-paclitaxel, is considered to be a standard-of-care, non-investigational chemotherapy combination; chemotherapy dosing and treatment schedule will be managed by the treating medical oncologist. Restaging will be completed post chemotherapy. Radiation therapy: 5 fractions of hypofractionated IGRT or IMRT at 5Gy per fraction will be delivered before surgery. Restaging will be completed post radiation therap
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	19 Participants n=93 Participants
Age, Categorical >=65 years	21 Participants n=93 Participants
Sex: Female, Male Female	21 Participants n=93 Participants
Sex: Female, Male Male	19 Participants n=93 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=93 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	40 Participants n=93 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	1 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	3 Participants n=93 Participants
Race (NIH/OMB) White	36 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Region of Enrollment United States	40 Participants n=93 Participants

PRIMARY outcome

Timeframe: approximately 6 months

Outcome measures

Outcome measures
Measure	Chemotherapy/Radiation/Surgery n=40 Participants This is a single arm prospective study. All eligible subjects will receive 2 cycles of neoadjuvant Gemcitabine/nab-Paclitaxel, followed by hypofractionated radiation therapy followed by surgical resection. Subjects may receive adjuvant chemotherapy post surgical resection at the clinical discretion of the medical oncologist. Radiation therapy: 5 fractions of hypofractionated IGRT or IMRT at 5Gy per fraction will be delivered before surgery. Restaging will be completed post radiation therapy.
Feasibility as Measured by Number of Participants Who Complete the Neoadjuvant Gemcitabine/Nab-paclitaxel and HIGRT Regimen	39 Participants

SECONDARY outcome

Timeframe: 60 days post surgery

CTCAE version 4 will be used for all toxicity assessments. The acute toxicity rate, defined as any non-hematologic grade 2+ toxicity occurring during HIGRT treatment through 60 days post-treatment, will be estimated with its exact 80% confidence interval. Likewise, we will determine the rate of grade 2+ hematologic toxicity occurring during treatment through 60 days post treatment and the proportion of patients requiring treatment breaks longer than 5 days.

Outcome measures

Outcome measures
Measure	Chemotherapy/Radiation/Surgery n=40 Participants This is a single arm prospective study. All eligible subjects will receive 2 cycles of neoadjuvant Gemcitabine/nab-Paclitaxel, followed by hypofractionated radiation therapy followed by surgical resection. Subjects may receive adjuvant chemotherapy post surgical resection at the clinical discretion of the medical oncologist. Radiation therapy: 5 fractions of hypofractionated IGRT or IMRT at 5Gy per fraction will be delivered before surgery. Restaging will be completed post radiation therapy.
Number of Participants Experiencing Grade >/=2 Acute Toxicity	10 Participants

SECONDARY outcome

Timeframe: 14-30 days post surgery

Patients who undergo surgical resection will be documented

Outcome measures

Outcome measures
Measure	Chemotherapy/Radiation/Surgery n=40 Participants This is a single arm prospective study. All eligible subjects will receive 2 cycles of neoadjuvant Gemcitabine/nab-Paclitaxel, followed by hypofractionated radiation therapy followed by surgical resection. Subjects may receive adjuvant chemotherapy post surgical resection at the clinical discretion of the medical oncologist. Radiation therapy: 5 fractions of hypofractionated IGRT or IMRT at 5Gy per fraction will be delivered before surgery. Restaging will be completed post radiation therapy.
Number of Participants Who Underwent Surgical Resection	24 Participants

SECONDARY outcome

Timeframe: 14-30 days post surgery

Population: Participants who underwent surgical resection.

Pathologic review will determine if an R0 resection has been performed. R0 resection indicates a microscopically margin-negative resection, in which no gross or microscopic tumor remains in the primary tumor bed.

Outcome measures

Outcome measures
Measure	Chemotherapy/Radiation/Surgery n=24 Participants This is a single arm prospective study. All eligible subjects will receive 2 cycles of neoadjuvant Gemcitabine/nab-Paclitaxel, followed by hypofractionated radiation therapy followed by surgical resection. Subjects may receive adjuvant chemotherapy post surgical resection at the clinical discretion of the medical oncologist. Radiation therapy: 5 fractions of hypofractionated IGRT or IMRT at 5Gy per fraction will be delivered before surgery. Restaging will be completed post radiation therapy.
Number of Participants Who Received an R0 Resection	18 Participants

Adverse Events

Chemotherapy/Radiation/Surgery

Serious events: 3 serious events

Other events: 30 other events

Deaths: 24 deaths

Serious adverse events

Serious adverse events
Measure	Chemotherapy/Radiation/Surgery n=40 participants at risk This is a single arm prospective study. All eligible subjects will recieve 2 cycles of neoadjuvant Gemcitabine/nab-Paclitaxel, followed by hypofractionated radiation therapy followed by surgical resection. Subjects may receive adjuvant chemotherapy post surgical resection at the clinical discretion of the medical oncologist. Radiation therapy: 5 fractions of hypofractionated IGRT or IMRT at 5Gy per fraction will be delivered before surgery. Restaging will be completed post radiation therap
Blood and lymphatic system disorders Anemia	5.0% 2/40 • Number of events 2 • Adverse events were collected from the time of HIGRT through 60 days post surgery, about 6 months.
Gastrointestinal disorders Ascites	2.5% 1/40 • Number of events 1 • Adverse events were collected from the time of HIGRT through 60 days post surgery, about 6 months.
Gastrointestinal disorders Diarrhea	2.5% 1/40 • Number of events 1 • Adverse events were collected from the time of HIGRT through 60 days post surgery, about 6 months.
General disorders Death NOS	2.5% 1/40 • Number of events 1 • Adverse events were collected from the time of HIGRT through 60 days post surgery, about 6 months.
General disorders Fever	2.5% 1/40 • Number of events 1 • Adverse events were collected from the time of HIGRT through 60 days post surgery, about 6 months.
Infections and infestations Catheter related infection	2.5% 1/40 • Number of events 1 • Adverse events were collected from the time of HIGRT through 60 days post surgery, about 6 months.
Infections and infestations Infections and infestations	5.0% 2/40 • Number of events 2 • Adverse events were collected from the time of HIGRT through 60 days post surgery, about 6 months.
Infections and infestations Sepsis	2.5% 1/40 • Number of events 1 • Adverse events were collected from the time of HIGRT through 60 days post surgery, about 6 months.
Infections and infestations Small intestine infection	2.5% 1/40 • Number of events 1 • Adverse events were collected from the time of HIGRT through 60 days post surgery, about 6 months.
Infections and infestations Urinary tract infection	5.0% 2/40 • Number of events 2 • Adverse events were collected from the time of HIGRT through 60 days post surgery, about 6 months.
Infections and infestations Wound infection	7.5% 3/40 • Number of events 3 • Adverse events were collected from the time of HIGRT through 60 days post surgery, about 6 months.
Injury, poisoning and procedural complications Pancreatic anastomotic leak	2.5% 1/40 • Number of events 1 • Adverse events were collected from the time of HIGRT through 60 days post surgery, about 6 months.
Injury, poisoning and procedural complications Wound complication	2.5% 1/40 • Number of events 1 • Adverse events were collected from the time of HIGRT through 60 days post surgery, about 6 months.
Investigations Neutrophil count decreased	5.0% 2/40 • Number of events 2 • Adverse events were collected from the time of HIGRT through 60 days post surgery, about 6 months.
Metabolism and nutrition disorders Dehydration	5.0% 2/40 • Number of events 2 • Adverse events were collected from the time of HIGRT through 60 days post surgery, about 6 months.
Renal and urinary disorders Acute kidney injury	2.5% 1/40 • Number of events 2 • Adverse events were collected from the time of HIGRT through 60 days post surgery, about 6 months.
Renal and urinary disorders Renal and urinary disorders	2.5% 1/40 • Number of events 1 • Adverse events were collected from the time of HIGRT through 60 days post surgery, about 6 months.
Vascular disorders Thromboembolic event	2.5% 1/40 • Number of events 1 • Adverse events were collected from the time of HIGRT through 60 days post surgery, about 6 months.

Other adverse events

Other adverse events
Measure	Chemotherapy/Radiation/Surgery n=40 participants at risk This is a single arm prospective study. All eligible subjects will recieve 2 cycles of neoadjuvant Gemcitabine/nab-Paclitaxel, followed by hypofractionated radiation therapy followed by surgical resection. Subjects may receive adjuvant chemotherapy post surgical resection at the clinical discretion of the medical oncologist. Radiation therapy: 5 fractions of hypofractionated IGRT or IMRT at 5Gy per fraction will be delivered before surgery. Restaging will be completed post radiation therap
Blood and lymphatic system disorders Anemia	15.0% 6/40 • Number of events 7 • Adverse events were collected from the time of HIGRT through 60 days post surgery, about 6 months.
Blood and lymphatic system disorders Blood and lymphatic system disorders	5.0% 2/40 • Number of events 2 • Adverse events were collected from the time of HIGRT through 60 days post surgery, about 6 months.
Gastrointestinal disorders Abdominal pain	25.0% 10/40 • Number of events 10 • Adverse events were collected from the time of HIGRT through 60 days post surgery, about 6 months.
Gastrointestinal disorders Bloating	15.0% 6/40 • Number of events 6 • Adverse events were collected from the time of HIGRT through 60 days post surgery, about 6 months.
Gastrointestinal disorders Constipation	40.0% 16/40 • Number of events 17 • Adverse events were collected from the time of HIGRT through 60 days post surgery, about 6 months.
Gastrointestinal disorders Diarrhea	42.5% 17/40 • Number of events 19 • Adverse events were collected from the time of HIGRT through 60 days post surgery, about 6 months.
Gastrointestinal disorders Dyspepsia	7.5% 3/40 • Number of events 3 • Adverse events were collected from the time of HIGRT through 60 days post surgery, about 6 months.
Gastrointestinal disorders Gastrointestinal disorders	15.0% 6/40 • Number of events 6 • Adverse events were collected from the time of HIGRT through 60 days post surgery, about 6 months.
Gastrointestinal disorders Gastroparesis	5.0% 2/40 • Number of events 2 • Adverse events were collected from the time of HIGRT through 60 days post surgery, about 6 months.
Gastrointestinal disorders Mucositis oral	5.0% 2/40 • Number of events 2 • Adverse events were collected from the time of HIGRT through 60 days post surgery, about 6 months.
Gastrointestinal disorders Nausea	67.5% 27/40 • Number of events 33 • Adverse events were collected from the time of HIGRT through 60 days post surgery, about 6 months.
Gastrointestinal disorders Vomiting	27.5% 11/40 • Number of events 14 • Adverse events were collected from the time of HIGRT through 60 days post surgery, about 6 months.
General disorders Chills	5.0% 2/40 • Number of events 2 • Adverse events were collected from the time of HIGRT through 60 days post surgery, about 6 months.
General disorders Edema limbs	12.5% 5/40 • Number of events 5 • Adverse events were collected from the time of HIGRT through 60 days post surgery, about 6 months.
General disorders Fatigue	75.0% 30/40 • Number of events 34 • Adverse events were collected from the time of HIGRT through 60 days post surgery, about 6 months.
General disorders Fever	15.0% 6/40 • Number of events 7 • Adverse events were collected from the time of HIGRT through 60 days post surgery, about 6 months.
General disorders Flu like symptoms	15.0% 6/40 • Number of events 8 • Adverse events were collected from the time of HIGRT through 60 days post surgery, about 6 months.
General disorders Pain	32.5% 13/40 • Number of events 13 • Adverse events were collected from the time of HIGRT through 60 days post surgery, about 6 months.
Infections and infestations Skin infection	7.5% 3/40 • Number of events 3 • Adverse events were collected from the time of HIGRT through 60 days post surgery, about 6 months.
Infections and infestations Urinary tract infection	15.0% 6/40 • Number of events 7 • Adverse events were collected from the time of HIGRT through 60 days post surgery, about 6 months.
Infections and infestations Wound infection	10.0% 4/40 • Number of events 4 • Adverse events were collected from the time of HIGRT through 60 days post surgery, about 6 months.
Injury, poisoning and procedural complications Injury, poisoning and procedural complications	5.0% 2/40 • Number of events 2 • Adverse events were collected from the time of HIGRT through 60 days post surgery, about 6 months.
Investigations Alanine aminotransferase increased	12.5% 5/40 • Number of events 6 • Adverse events were collected from the time of HIGRT through 60 days post surgery, about 6 months.
Investigations Alkaline phosphatase increased	7.5% 3/40 • Number of events 3 • Adverse events were collected from the time of HIGRT through 60 days post surgery, about 6 months.
Investigations Aspartate aminotransferase increased	12.5% 5/40 • Number of events 6 • Adverse events were collected from the time of HIGRT through 60 days post surgery, about 6 months.
Investigations Neutrophil count decreased	50.0% 20/40 • Number of events 43 • Adverse events were collected from the time of HIGRT through 60 days post surgery, about 6 months.
Investigations Platelet count decreased	32.5% 13/40 • Number of events 22 • Adverse events were collected from the time of HIGRT through 60 days post surgery, about 6 months.
Investigations Weight loss	7.5% 3/40 • Number of events 3 • Adverse events were collected from the time of HIGRT through 60 days post surgery, about 6 months.
Investigations White blood cell decreased	27.5% 11/40 • Number of events 15 • Adverse events were collected from the time of HIGRT through 60 days post surgery, about 6 months.
Metabolism and nutrition disorders Anorexia	12.5% 5/40 • Number of events 5 • Adverse events were collected from the time of HIGRT through 60 days post surgery, about 6 months.
Metabolism and nutrition disorders Dehydration	7.5% 3/40 • Number of events 3 • Adverse events were collected from the time of HIGRT through 60 days post surgery, about 6 months.
Metabolism and nutrition disorders Hypokalemia	5.0% 2/40 • Number of events 2 • Adverse events were collected from the time of HIGRT through 60 days post surgery, about 6 months.
Metabolism and nutrition disorders Hyponatremia	5.0% 2/40 • Number of events 3 • Adverse events were collected from the time of HIGRT through 60 days post surgery, about 6 months.
Musculoskeletal and connective tissue disorders Arthralgia	12.5% 5/40 • Number of events 5 • Adverse events were collected from the time of HIGRT through 60 days post surgery, about 6 months.
Nervous system disorders Dizziness	10.0% 4/40 • Number of events 4 • Adverse events were collected from the time of HIGRT through 60 days post surgery, about 6 months.
Nervous system disorders Nervous system disorders	7.5% 3/40 • Number of events 3 • Adverse events were collected from the time of HIGRT through 60 days post surgery, about 6 months.
Nervous system disorders Peripheral sensory neuropathy	7.5% 3/40 • Number of events 3 • Adverse events were collected from the time of HIGRT through 60 days post surgery, about 6 months.
Renal and urinary disorders Acute kidney injury	5.0% 2/40 • Number of events 2 • Adverse events were collected from the time of HIGRT through 60 days post surgery, about 6 months.
Renal and urinary disorders Urinary frequency	5.0% 2/40 • Number of events 2 • Adverse events were collected from the time of HIGRT through 60 days post surgery, about 6 months.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders	17.5% 7/40 • Number of events 8 • Adverse events were collected from the time of HIGRT through 60 days post surgery, about 6 months.
Vascular disorders Hematoma	5.0% 2/40 • Number of events 2 • Adverse events were collected from the time of HIGRT through 60 days post surgery, about 6 months.
Vascular disorders Thromboembolic event	7.5% 3/40 • Number of events 3 • Adverse events were collected from the time of HIGRT through 60 days post surgery, about 6 months.

Additional Information

Linda Kaltenbach, PhD

Regulatory Coordinator

Phone: (919) 681-6804

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place