Trial Outcomes & Findings for A Study of Neoadjuvant FOLFIRINOX and FDR-Gemcitabine With Concurrent IMRT in Patients (NCT NCT01661088)
NCT ID: NCT01661088
Last Updated: 2019-11-13
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
25 participants
Primary outcome timeframe
6 months
Results posted on
2019-11-13
Participant Flow
Participant milestones
| Measure |
Study Treatment
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.
|
|---|---|
|
FOLFIRINOX
STARTED
|
25
|
|
FOLFIRINOX
COMPLETED
|
21
|
|
FOLFIRINOX
NOT COMPLETED
|
4
|
|
IMRT With FDR Gemcitabine
STARTED
|
21
|
|
IMRT With FDR Gemcitabine
COMPLETED
|
19
|
|
IMRT With FDR Gemcitabine
NOT COMPLETED
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of Neoadjuvant FOLFIRINOX and FDR-Gemcitabine With Concurrent IMRT in Patients
Baseline characteristics by cohort
| Measure |
Study Treatment
n=25 Participants
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.
|
|---|---|
|
Age, Continuous
|
60 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
23 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 6 monthsTo 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.
Outcome measures
| Measure |
Study Treatment
n=25 Participants
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.
|
|---|---|
|
The Percentage of Patients That Underwent an R0 Resection
|
52 percentage of patients
|
SECONDARY outcome
Timeframe: up to 2 yearsTo 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
Outcome measures
| Measure |
Study Treatment
n=25 Participants
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.
|
|---|---|
|
Median Progression-free Survival Time
|
13.1 months
Interval 7.3 to 24.7
|
SECONDARY outcome
Timeframe: up to 2 yearsTo estimate overall survival as a function of time from study enrollment.
Outcome measures
| Measure |
Study Treatment
n=25 Participants
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.
|
|---|---|
|
Median Overall Survival Time
|
24.4 months
Interval 12.6 to 40.0
|
Adverse Events
Study Treatment
Serious events: 6 serious events
Other events: 21 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Study Treatment
n=25 participants at risk
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.
|
|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
4.0%
1/25 • Number of events 1 • 30 days post treatment
|
|
Cardiac disorders
Cardiac arrest
|
4.0%
1/25 • Number of events 1 • 30 days post treatment
|
|
Cardiac disorders
Chest pain - cardiac
|
4.0%
1/25 • Number of events 1 • 30 days post treatment
|
|
Gastrointestinal disorders
Esophagitis
|
4.0%
1/25 • Number of events 1 • 30 days post treatment
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other
|
4.0%
1/25 • Number of events 1 • 30 days post treatment
|
|
Gastrointestinal disorders
Lower gastrointestinal hemorrhage
|
4.0%
1/25 • Number of events 1 • 30 days post treatment
|
|
Gastrointestinal disorders
Nausea
|
8.0%
2/25 • Number of events 2 • 30 days post treatment
|
|
Gastrointestinal disorders
Vomiting
|
8.0%
2/25 • Number of events 2 • 30 days post treatment
|
|
Infections and infestations
Lung infection
|
4.0%
1/25 • Number of events 1 • 30 days post treatment
|
|
Nervous system disorders
Dysphasia
|
4.0%
1/25 • Number of events 1 • 30 days post treatment
|
Other adverse events
| Measure |
Study Treatment
n=25 participants at risk
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.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
16.0%
4/25 • Number of events 6 • 30 days post treatment
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
4.0%
1/25 • Number of events 1 • 30 days post treatment
|
|
Gastrointestinal disorders
Abdominal distension
|
4.0%
1/25 • Number of events 1 • 30 days post treatment
|
|
Gastrointestinal disorders
Abdominal pain
|
20.0%
5/25 • Number of events 5 • 30 days post treatment
|
|
Gastrointestinal disorders
Diarrhea
|
24.0%
6/25 • Number of events 6 • 30 days post treatment
|
|
Gastrointestinal disorders
Mucositis oral
|
8.0%
2/25 • Number of events 2 • 30 days post treatment
|
|
Gastrointestinal disorders
Nausea
|
16.0%
4/25 • Number of events 6 • 30 days post treatment
|
|
Gastrointestinal disorders
Stomach pain
|
4.0%
1/25 • Number of events 1 • 30 days post treatment
|
|
Gastrointestinal disorders
Vomiting
|
12.0%
3/25 • Number of events 4 • 30 days post treatment
|
|
General disorders
Chills
|
4.0%
1/25 • Number of events 1 • 30 days post treatment
|
|
General disorders
Fatigue
|
16.0%
4/25 • Number of events 5 • 30 days post treatment
|
|
General disorders
Fever
|
4.0%
1/25 • Number of events 1 • 30 days post treatment
|
|
General disorders
Non-cardiac chest pain
|
4.0%
1/25 • Number of events 1 • 30 days post treatment
|
|
Hepatobiliary disorders
Bile duct stenosis
|
4.0%
1/25 • Number of events 1 • 30 days post treatment
|
|
Hepatobiliary disorders
Cholecystitis
|
4.0%
1/25 • Number of events 2 • 30 days post treatment
|
|
Infections and infestations
Abdominal infection
|
4.0%
1/25 • Number of events 1 • 30 days post treatment
|
|
Infections and infestations
Biliary tract infection
|
8.0%
2/25 • Number of events 3 • 30 days post treatment
|
|
Infections and infestations
Skin infection
|
4.0%
1/25 • Number of events 1 • 30 days post treatment
|
|
Infections and infestations
Urinary tract infection
|
4.0%
1/25 • Number of events 1 • 30 days post treatment
|
|
Investigations
Alanine aminotransferase increased
|
16.0%
4/25 • Number of events 5 • 30 days post treatment
|
|
Investigations
Alkaline phosphatase increased
|
4.0%
1/25 • Number of events 2 • 30 days post treatment
|
|
Investigations
Aspartate aminotransferase increased
|
16.0%
4/25 • Number of events 4 • 30 days post treatment
|
|
Investigations
Blood bilirubin increased
|
4.0%
1/25 • Number of events 1 • 30 days post treatment
|
|
Investigations
Lymphocyte count decreased
|
32.0%
8/25 • Number of events 14 • 30 days post treatment
|
|
Investigations
Lymphocyte count increased
|
4.0%
1/25 • Number of events 1 • 30 days post treatment
|
|
Investigations
Neutrophil count decreased
|
40.0%
10/25 • Number of events 15 • 30 days post treatment
|
|
Investigations
Platelet count decreased
|
12.0%
3/25 • Number of events 5 • 30 days post treatment
|
|
Investigations
White blood cell decreased
|
36.0%
9/25 • Number of events 10 • 30 days post treatment
|
|
Metabolism and nutrition disorders
Anorexia
|
8.0%
2/25 • Number of events 2 • 30 days post treatment
|
|
Metabolism and nutrition disorders
Dehydration
|
4.0%
1/25 • Number of events 1 • 30 days post treatment
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
24.0%
6/25 • Number of events 10 • 30 days post treatment
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
4.0%
1/25 • Number of events 1 • 30 days post treatment
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
4.0%
1/25 • Number of events 1 • 30 days post treatment
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
4.0%
1/25 • Number of events 1 • 30 days post treatment
|
|
Metabolism and nutrition disorders
Hypokalemia
|
4.0%
1/25 • Number of events 1 • 30 days post treatment
|
|
Metabolism and nutrition disorders
Hyponatremia
|
4.0%
1/25 • Number of events 1 • 30 days post treatment
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.0%
1/25 • Number of events 1 • 30 days post treatment
|
|
Nervous system disorders
Ataxia
|
4.0%
1/25 • Number of events 1 • 30 days post treatment
|
|
Nervous system disorders
Dysarthria
|
4.0%
1/25 • Number of events 1 • 30 days post treatment
|
|
Nervous system disorders
Dysgeusia
|
4.0%
1/25 • Number of events 1 • 30 days post treatment
|
|
Nervous system disorders
Extrapyramidal disorder
|
4.0%
1/25 • Number of events 1 • 30 days post treatment
|
|
Nervous system disorders
Paresthesia
|
4.0%
1/25 • Number of events 1 • 30 days post treatment
|
|
Nervous system disorders
Peripheral motor neuropathy
|
4.0%
1/25 • Number of events 1 • 30 days post treatment
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
4.0%
1/25 • Number of events 1 • 30 days post treatment
|
|
Psychiatric disorders
Anxiety
|
4.0%
1/25 • Number of events 1 • 30 days post treatment
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
4.0%
1/25 • Number of events 1 • 30 days post treatment
|
|
Vascular disorders
Hypertension
|
4.0%
1/25 • Number of events 2 • 30 days post treatment
|
Additional Information
Mark Zalupski, M.D.
University of Michigan Rogel Cancer Center
Phone: 734-647-8902
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place