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A Study of Neoadjuvant FOLFIRINOX and FDR-Gemcitabine With Concurrent IMRT in Patients

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ClinicalTrials.gov Identifier: NCT01661088
Recruitment Status : Active, not recruiting
First Posted : August 9, 2012
Results First Posted : August 8, 2018
Last Update Posted : May 1, 2019
Sponsor:
Information provided by (Responsible Party):
University of Michigan Rogel Cancer Center

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Pancreatic Cancer
Interventions Drug: FOLFIRINOX
Radiation: Intensity-modulated radiotherapy (IMRT)
Procedure: Surgical Exploration
Enrollment 25
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Study Treatment
Hide Arm/Group Description

Patients received FOLFIRINOX x 6 followed by IMRT concurrent with fixed dose rate (FDR)-gemcitabine (1g/m^2) on days 1, 8, 22, 29.

Intensity-modulated radiotherapy (IMRT): The prescribed dose was 50.0Gy in 2.0Gy per fraction.

Patients without metastatic disease were offered surgical exploration.

Period Title: FOLFIRINOX
Started 25
Completed 21
Not Completed 4
Period Title: IMRT With FDR Gemcitabine
Started 21
Completed 19
Not Completed 2
Arm/Group Title Study Treatment
Hide Arm/Group Description

Patients received FOLFIRINOX x 6 followed by IMRT concurrent with fixed dose rate (FDR)-gemcitabine (1g/m^2) on days 1, 8, 22, 29.

Intensity-modulated radiotherapy (IMRT): The prescribed dose was 50.0Gy in 2.0Gy per fraction.

Patients without metastatic disease were offered surgical exploration.

Overall Number of Baseline Participants 25
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 25 participants
60
(46 to 77)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants
Female
9
  36.0%
Male
16
  64.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants
Hispanic or Latino
1
   4.0%
Not Hispanic or Latino
24
  96.0%
Unknown or Not Reported
0
   0.0%
1.Primary Outcome
Title The Percentage of Patients That Underwent an R0 Resection
Hide Description To determine the frequency of achieving an R0 resection using a neoadjuvant regimen of FOLFIRINOX followed by IMRT concurrent with fixed dose rate (FDR)-gemcitabine in patients with borderline resectable pancreatic cancer. R0 resection indicates a microscopically margin-negative resection, in which no gross or microscopic tumor remains in the primary tumor bed.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Study Treatment
Hide Arm/Group Description:

Patients received FOLFIRINOX x 6 followed by IMRT concurrent with fixed dose rate (FDR)-gemcitabine (1g/m^2) on days 1, 8, 22, 29.

Intensity-modulated radiotherapy (IMRT): The prescribed dose was 50.0Gy in 2.0Gy per fraction.

Patients without metastatic disease were offered surgical exploration.

Overall Number of Participants Analyzed 25
Measure Type: Number
Unit of Measure: percentage of patients
52
2.Secondary Outcome
Title Median Progression-free Survival Time
Hide Description To estimate progression-free survival as a function of time from study enrollment. Progression is defined as at least a 20% increase in the LD (longest diameter) of the primary lesion or the appearance of one or more new lesions
Time Frame up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Study Treatment
Hide Arm/Group Description:

Patients received FOLFIRINOX x 6 followed by IMRT concurrent with fixed dose rate (FDR)-gemcitabine (1g/m^2) on days 1, 8, 22, 29.

Intensity-modulated radiotherapy (IMRT): The prescribed dose was 50.0Gy in 2.0Gy per fraction.

Patients without metastatic disease were offered surgical exploration.

Overall Number of Participants Analyzed 25
Median (95% Confidence Interval)
Unit of Measure: months
18.1
(10.6 to 25.1)
3.Secondary Outcome
Title Median Overall Survival Time
Hide Description To estimate overall survival as a function of time from study enrollment.
Time Frame up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Study Treatment
Hide Arm/Group Description:

Patients received FOLFIRINOX x 6 followed by IMRT concurrent with fixed dose rate (FDR)-gemcitabine (1g/m^2) on days 1, 8, 22, 29.

Intensity-modulated radiotherapy (IMRT): The prescribed dose was 50.0Gy in 2.0Gy per fraction.

Patients without metastatic disease were offered surgical exploration.

Overall Number of Participants Analyzed 25
Median (95% Confidence Interval)
Unit of Measure: months
24.2
(12.6 to 40)
Time Frame 30 days post treatment
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Study Treatment
Hide Arm/Group Description

Patients received FOLFIRINOX x 6 followed by IMRT concurrent with fixed dose rate (FDR)-gemcitabine (1g/m^2) on days 1, 8, 22, 29.

Intensity-modulated radiotherapy (IMRT): The prescribed dose was 50.0Gy in 2.0Gy per fraction.

Patients without metastatic disease were offered surgical exploration.

All-Cause Mortality
Study Treatment
Affected / at Risk (%)
Total   1/25 (4.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Study Treatment
Affected / at Risk (%) # Events
Total   6/25 (24.00%)    
Blood and lymphatic system disorders   
Febrile neutropenia   1/25 (4.00%)  1
Cardiac disorders   
Cardiac arrest   1/25 (4.00%)  1
Chest pain - cardiac *  1/25 (4.00%)  1
Gastrointestinal disorders   
Esophagitis   1/25 (4.00%)  1
Gastrointestinal disorders - Other   1/25 (4.00%)  1
Lower gastrointestinal hemorrhage   1/25 (4.00%)  1
Nausea *  2/25 (8.00%)  2
Vomiting *  2/25 (8.00%)  2
Infections and infestations   
Lung infection   1/25 (4.00%)  1
Nervous system disorders   
Dysphasia   1/25 (4.00%)  1
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Study Treatment
Affected / at Risk (%) # Events
Total   21/25 (84.00%)    
Blood and lymphatic system disorders   
Anemia   4/25 (16.00%)  6
Febrile neutropenia   1/25 (4.00%)  1
Gastrointestinal disorders   
Abdominal distension   1/25 (4.00%)  1
Abdominal pain *  5/25 (20.00%)  5
Diarrhea *  6/25 (24.00%)  6
Mucositis oral   2/25 (8.00%)  2
Nausea *  4/25 (16.00%)  6
Stomach pain *  1/25 (4.00%)  1
Vomiting *  3/25 (12.00%)  4
General disorders   
Chills *  1/25 (4.00%)  1
Fatigue *  4/25 (16.00%)  5
Fever   1/25 (4.00%)  1
Non-cardiac chest pain   1/25 (4.00%)  1
Hepatobiliary disorders   
Bile duct stenosis   1/25 (4.00%)  1
Cholecystitis   1/25 (4.00%)  2
Infections and infestations   
Abdominal infection   1/25 (4.00%)  1
Biliary tract infection   2/25 (8.00%)  3
Skin infection   1/25 (4.00%)  1
Urinary tract infection   1/25 (4.00%)  1
Investigations   
Alanine aminotransferase increased   4/25 (16.00%)  5
Alkaline phosphatase increased   1/25 (4.00%)  2
Aspartate aminotransferase increased   4/25 (16.00%)  4
Blood bilirubin increased   1/25 (4.00%)  1
Lymphocyte count decreased   8/25 (32.00%)  14
Lymphocyte count increased   1/25 (4.00%)  1
Neutrophil count decreased   10/25 (40.00%)  15
Platelet count decreased   3/25 (12.00%)  5
White blood cell decreased   9/25 (36.00%)  10
Metabolism and nutrition disorders   
Anorexia   2/25 (8.00%)  2
Dehydration   1/25 (4.00%)  1
Hyperglycemia   6/25 (24.00%)  10
Hypoalbuminemia   1/25 (4.00%)  1
Hypocalcemia   1/25 (4.00%)  1
Hypoglycemia   1/25 (4.00%)  1
Hypokalemia   1/25 (4.00%)  1
Hyponatremia   1/25 (4.00%)  1
Musculoskeletal and connective tissue disorders   
Back pain *  1/25 (4.00%)  1
Nervous system disorders   
Ataxia   1/25 (4.00%)  1
Dysarthria   1/25 (4.00%)  1
Dysgeusia   1/25 (4.00%)  1
Extrapyramidal disorder   1/25 (4.00%)  1
Paresthesia   1/25 (4.00%)  1
Peripheral motor neuropathy   1/25 (4.00%)  1
Peripheral sensory neuropathy   1/25 (4.00%)  1
Psychiatric disorders   
Anxiety   1/25 (4.00%)  1
Skin and subcutaneous tissue disorders   
Dry skin   1/25 (4.00%)  1
Vascular disorders   
Hypertension   1/25 (4.00%)  2
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
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: Mark Zalupski, M.D.
Organization: University of Michigan Rogel Cancer Center
Phone: 734-647-8902
EMail: zalupski@med.umich.edu
Layout table for additonal information
Responsible Party: University of Michigan Rogel Cancer Center
ClinicalTrials.gov Identifier: NCT01661088     History of Changes
Other Study ID Numbers: UMCC 2011.007
HUM 47389 ( Other Identifier: University of Michigan IRBMED )
First Submitted: July 24, 2012
First Posted: August 9, 2012
Results First Submitted: June 26, 2018
Results First Posted: August 8, 2018
Last Update Posted: May 1, 2019