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

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ClinicalTrials.gov Identifier: NCT02241551
Recruitment Status : Terminated (Study was terminated with the IRB ended early as logistical concerns of the SBRT)
First Posted : September 16, 2014
Results First Posted : June 15, 2018
Last Update Posted : July 25, 2018
Sponsor:
Information provided by (Responsible Party):
Nathan Bahary, MD, University of Pittsburgh

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Borderline Resectable Pancreatic Cancer
Interventions Drug: gemcitabine/nab-paclitaxel
Drug: mFOLFIRINOX
Enrollment 2
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Gemcitabine/Nab-paclitaxel mFOLFIRINOX
Hide Arm/Group Description Patients that received three cycles of treatment in the gemcitabine/nab-paclitaxel Patients that received 6 cycles in the mFOLFIRINOX
Period Title: Overall Study
Started 1 0
Completed 0 0
Not Completed 1 0
Reason Not Completed
Adverse Event             1             0
Arm/Group Title Gemcitabine/Nab-paclitaxel mFOLFIRINOX Total
Hide Arm/Group Description Patients that received three cycles of treatment in the gemcitabine/nab-paclitaxel Patients that received 6 cycles in the mFOLFIRINOX Total of all reporting groups
Overall Number of Baseline Participants 1 0 1
Hide Baseline Analysis Population Description
The number of participants analyzed or is zero for the Treatment Arm in which zero participants were treated.
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 1 participants 0 participants 1 participants
54
(54 to 54)
54
(54 to 54)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 0 participants 1 participants
Female
1
 100.0%
0
1
 100.0%
Male
0
   0.0%
0
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 0 participants 1 participants
American Indian or Alaska Native
0
   0.0%
0
0
   0.0%
Asian
0
   0.0%
0
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
0
   0.0%
Black or African American
1
 100.0%
0
1
 100.0%
White
0
   0.0%
0
0
   0.0%
More than one race
0
   0.0%
0
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
0
   0.0%
1.Primary Outcome
Title Safety and Efficacy Using Neo-adjuvant Gemcitabine Plus Nab-paclitaxel in Patients Receiving SBRT and Surgery for Borderline Resectable Pancreatic Cancer, Using Neo-adjuvant mFOLFIRINOX as a Control
Hide Description Efficacy: pathological complete response (pCR) and R0 resection. Safety: Grade 4 toxicity.
Time Frame up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
Patient did not receive three cycles of treatment - data were not collected.
Arm/Group Title Gemcitabine/Nab-paclitaxel mFOLFIRINOX
Hide Arm/Group Description:
Patients that received three cycles of treatment in the gemcitabine/nab-paclitaxel
Patients that received 6 cycles in the mFOLFIRINOX
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title R0 Resection Rates in Borderline Resectable Pancreatic Cancer
Hide Description [Not Specified]
Time Frame Up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
Patient did not receive three cycles of treatment - data were not collected.
Arm/Group Title Gemcitabine/Nab-paclitaxel mFOLFIRINOX
Hide Arm/Group Description:
Patients that received three cycles of treatment in the gemcitabine/nab-paclitaxel
Patients that received 6 cycles in the mFOLFIRINOX
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Incidence of Grade 3 and 4 Toxicities for the 2 Chemotherapy Regimens That Occur After Cycle 1 Day 1
Hide Description According to the National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTAE, v4.0)
Time Frame Up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
Patient was not treated - no data collected.
Arm/Group Title Gemcitabine/Nab-paclitaxel mFOLFIRINOX
Hide Arm/Group Description:
Patients that received three cycles of treatment in the gemcitabine/nab-paclitaxel
Patients that received 6 cycles in the mFOLFIRINOX
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Ca19-9 Response to Neoadjuvant Chemotherapy
Hide Description [Not Specified]
Time Frame Up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
Patient did not receive three cycles of treatment - data were not collected / zero total participants were analyzed.
Arm/Group Title Gemcitabine/Nab-paclitaxel mFOLFIRINOX
Hide Arm/Group Description:

three cycles of treatment in the gemcitabine/nab-paclitaxel

gemcitabine/nab-paclitaxel: three cycles of treatment in the gemcitabine/nab-paclitaxel

6 cycles in the mFOLFIRINOX

mFOLFIRINOX: 6 cycles in the mFOLFIRINOX

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Time to Disease Progression
Hide Description [Not Specified]
Time Frame Up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
Patient did not receive three cycles of treatment - data not collected.
Arm/Group Title Gemcitabine/Nab-paclitaxel mFOLFIRINOX
Hide Arm/Group Description:
Patients that received three cycles of treatment in the gemcitabine/nab-paclitaxel
Patients that received 6 cycles in the mFOLFIRINOX
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Measurement of Biomarkers (SPARC, RM1 and SMAD4) in Tissues
Hide Description This wil be measured in tissues that are obtained at screening and in the resected tumour specimen
Time Frame Up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
Patient did not receive three cycles of treatment - data not collected.
Arm/Group Title Gemcitabine/Nab-paclitaxel mFOLFIRINOX
Hide Arm/Group Description:
Patients that received three cycles of treatment in the gemcitabine/nab-paclitaxel
Patients that received 6 cycles in the mFOLFIRINOX
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title Radiological Response Rate to Therapy
Hide Description Radiological improvements will be evaluated by determining changes in density of measurable disease on CT scan pre and post chemotherapy
Time Frame Up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
Patient did not receive three cycles of treatment - data not collected.
Arm/Group Title Gemcitabine/Nab-paclitaxel mFOLFIRINOX
Hide Arm/Group Description:
Patients that received three cycles of treatment in the gemcitabine/nab-paclitaxel
Patients that received 6 cycles in the mFOLFIRINOX
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
8.Secondary Outcome
Title Quality of Life Effects of Chemotherapy on Patients Receiving Chemotherapy and SBRT
Hide Description This will be measured using the FACT-HB questionaire
Time Frame Up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
Patient did not receive three cycles of treatment - data not collected.
Arm/Group Title Gemcitabine/Nab-paclitaxel mFOLFIRINOX
Hide Arm/Group Description:

three cycles of treatment in the gemcitabine/nab-paclitaxel

gemcitabine/nab-paclitaxel: three cycles of treatment in the gemcitabine/nab-paclitaxel

6 cycles in the mFOLFIRINOX

mFOLFIRINOX: 6 cycles in the mFOLFIRINOX

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame 6 months
Adverse Event Reporting Description

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.

 
Arm/Group Title Gemcitabine/Nab-paclitaxel mFOLFIRINOX
Hide Arm/Group Description Patients that received three cycles of treatment in the gemcitabine/nab-paclitaxel Patients that received 6 cycles in the mFOLFIRINOX
All-Cause Mortality
Gemcitabine/Nab-paclitaxel mFOLFIRINOX
Affected / at Risk (%) Affected / at Risk (%)
Total   1/1 (100.00%)      0/0    
Show Serious Adverse Events Hide Serious Adverse Events
Gemcitabine/Nab-paclitaxel mFOLFIRINOX
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/1 (100.00%)      0/0    
Musculoskeletal and connective tissue disorders     
Myositis   1/1 (100.00%)  1 0/0  0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Gemcitabine/Nab-paclitaxel mFOLFIRINOX
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/1 (0.00%)      0/0    
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Nathan Bahary, MD
Organization: University of Pittsburgh Cancer Institute
Phone: 412-864-7764
EMail: baharyn@upmc.edu
Layout table for additonal information
Responsible Party: Nathan Bahary, MD, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT02241551     History of Changes
Other Study ID Numbers: UPCI 13-143
First Submitted: August 29, 2014
First Posted: September 16, 2014
Results First Submitted: March 5, 2018
Results First Posted: June 15, 2018
Last Update Posted: July 25, 2018