Trial Outcomes & Findings for Phase II Neoadjuvant Chemotheraphy (Gemcitabine and Nab-Paclitaxel vs. mFOLFIRINOX) and Sterotatic Body Radiation Therapy for Borderline Resectable Pancreatic Cancer (NCT NCT02241551)

Results Overview

Efficacy: pathological complete response (pCR) and R0 resection. Safety: Grade 4 toxicity.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

2 participants

Primary outcome timeframe

up to 5 years

Results posted on

2018-07-26

Participant Flow

Participant milestones

Participant milestones
Measure	Gemcitabine/Nab-paclitaxel Patients that received three cycles of treatment in the gemcitabine/nab-paclitaxel	mFOLFIRINOX Patients that received 6 cycles in the mFOLFIRINOX
Overall Study STARTED	1	0
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Gemcitabine/Nab-paclitaxel Patients that received three cycles of treatment in the gemcitabine/nab-paclitaxel	mFOLFIRINOX Patients that received 6 cycles in the mFOLFIRINOX
Overall Study Adverse Event	1	0

Baseline Characteristics

Phase II Neoadjuvant Chemotheraphy (Gemcitabine and Nab-Paclitaxel vs. mFOLFIRINOX) and Sterotatic Body Radiation Therapy for Borderline Resectable Pancreatic Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Gemcitabine/Nab-paclitaxel n=1 Participants Patients that received three cycles of treatment in the gemcitabine/nab-paclitaxel	mFOLFIRINOX Patients that received 6 cycles in the mFOLFIRINOX	Total n=1 Participants Total of all reporting groups
Age, Continuous	54 years n=5 Participants	—	54 years n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Male	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	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 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	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: up to 5 years

Population: Patient did not receive three cycles of treatment - data were not collected.

Efficacy: pathological complete response (pCR) and R0 resection. Safety: Grade 4 toxicity.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 5 years

Population: Patient did not receive three cycles of treatment - data were not collected.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 5 years

Population: Patient was not treated - no data collected.

According to the National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTAE, v4.0)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 5 years

Population: Patient did not receive three cycles of treatment - data were not collected / zero total participants were analyzed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 5 years

Population: Patient did not receive three cycles of treatment - data not collected.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 5 years

Population: Patient did not receive three cycles of treatment - data not collected.

This wil be measured in tissues that are obtained at screening and in the resected tumour specimen

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 5 years

Population: Patient did not receive three cycles of treatment - data not collected.

Radiological improvements will be evaluated by determining changes in density of measurable disease on CT scan pre and post chemotherapy

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 5 years

Population: Patient did not receive three cycles of treatment - data not collected.

This will be measured using the FACT-HB questionaire

Outcome measures

Outcome data not reported

Adverse Events

Gemcitabine/Nab-paclitaxel

Serious events: 1 serious events

Other events: 0 other events

Deaths: 1 deaths

mFOLFIRINOX

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Gemcitabine/Nab-paclitaxel n=1 participants at risk Patients that received three cycles of treatment in the gemcitabine/nab-paclitaxel	mFOLFIRINOX Patients that received 6 cycles in the mFOLFIRINOX
Musculoskeletal and connective tissue disorders Myositis	100.0% 1/1 • Number of events 1 • 6 months The number of participants at risk for Serious Adverse Events is zero for the Treatment Arm in which zero participants were treated. The number of participants at risk for Other (Not Including Serious) Adverse Events is zero for the Treatment Arm in which zero participants were treated. The number of participants at risk for All-Cause Mortality is zero for the Treatment Arm in which zero participants were treated.	— 0/0 • 6 months The number of participants at risk for Serious Adverse Events is zero for the Treatment Arm in which zero participants were treated. The number of participants at risk for Other (Not Including Serious) Adverse Events is zero for the Treatment Arm in which zero participants were treated. The number of participants at risk for All-Cause Mortality is zero for the Treatment Arm in which zero participants were treated.

Other adverse events

Adverse event data not reported

Additional Information

Nathan Bahary, MD

University of Pittsburgh Cancer Institute

Phone: 412-864-7764

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place