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Study was terminated due to low accrual.
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This study is for subjects with adenocarcinoma of the pancreas. The purpose of this research study is to determine the safety and effectiveness of modified Folfirinox and radiation therapy as treatment for adenocarcinoma (cancer) of the pancreas before surgery. Screening tests will be done to determine if subjects are eligible for participation in this study. If subjects are eligible to participate and agree to participate they will begin chemotherapy. After 3 cycles of chemotherapy, subjects will begin chemoradiation. Within 4 to 8 weeks of completing radiation therapy, subjects will have surgery. There will also be post-treatment and follow-up evaluations. Subjects will be followed for every 3 months for 3 years after their initial registration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chemotherapy, Chemoradiation, Surgery | Experimental | Neoadjuvant Chemotherapy- Modified FOLFIRINOX chemotherapy Day 1 and Day 15 of 28 day cycles for 3 cycles with growth factor support Chemoradiation Surgical Resection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neo-adjuvant Chemotherapy | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Estimate the R0/R1 Resection Rate | Estimate the R0/R1 resection rate as the proportion of patients with R0 or R1 resection status based on the ITT population. R0 resection status is macroscopic complete removal of tumor by non-contaminated operation, with neither macroscopic nor microscopic residual tumor. R1 resection status is macroscopic complete removal of tumor by non-contaminated operation, with microscopic residual tumor. | at time of surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Radiographic Tumor Response | The rate of CR, PR, SD and PD will be estimated as described in Section 14B prior to chemoradiation start and prior to surgery. The analysis population for estimation of radiographic response rate will be the ITT population. | From enrollment to Surgery |
| Histopathologic Tumor Response |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility Objective | The feasibility of treating patients with localized pancreatic head adenocarcinoma with this neoadjuvant regimen will be evaluated by estimating the proportion of patients completing five of six planned doses. The analysis population will be the ITT population. | From enrollment to end of chemotherapy part of the study |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul E. O'Brien, MD | Medical University of South Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Chemotherapy, Chemoradiation, Surgery | Neoadjuvant chemotherapy - modified FOLFIRINOX chemotherapy Day and and Day 15 of 28 days cycles for 3 cycles with growth factor support followed by chemoradiation for 6-8 weeks, then surgical resection |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Chemoradiation | Radiation |
|
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| Surgical Resection | Procedure |
|
|
Estimate the rate of good histopathologic response as the proportion of grade I and II responders. The analysis population for this objective is the ITT population. Any patient for whom a surgical sample is not available will be considered a poor-responder. |
| at the time of surgery |
| Time to Recurrence: | Time to recurrence is defined as the time from surgical resection to disease recurrence or death from any cause. Patients who have not recurred at the end of follow up will have their recurrence time censored at the last date of contact. | 2 years |
| Overall Survival: | Overall survival is defined as the time from enrollment to death from any cause. Patients still alive at the end of follow up will have their survival time censored at the last date of contact. | 2 years |
| CTC Analysis |
To evaluate and describe CTC numbers, CTC phenotype characteristics and effectiveness/rate of CTC culturing techniques from patients with pancreatic adenocarcinoma. |
| End of study |
| CTC Expression | To determine and evaluate the correlation between expression or biomarkers in the CTCs and expression of biomarkers in resected tissue specimens within the same cancer patient. | 2 years |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Chemotherapy, Chemoradiation, Surgery | Neoadjuvant chemotherapy - modified FOLFIRINOX chemotherapy Day and and Day 15 of 28 days cycles for 3 cycles with growth factor support followed by chemoradiation for 6-8 weeks, then surgical resection |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Estimate the R0/R1 Resection Rate | Estimate the R0/R1 resection rate as the proportion of patients with R0 or R1 resection status based on the ITT population. R0 resection status is macroscopic complete removal of tumor by non-contaminated operation, with neither macroscopic nor microscopic residual tumor. R1 resection status is macroscopic complete removal of tumor by non-contaminated operation, with microscopic residual tumor. | Only subjects who had surgery were included in the outcome measure data. | Posted | Number | participants | at time of surgery |
|
|
| |||||||||||||||||||||||||||||||||
| Secondary | Radiographic Tumor Response | The rate of CR, PR, SD and PD will be estimated as described in Section 14B prior to chemoradiation start and prior to surgery. The analysis population for estimation of radiographic response rate will be the ITT population. | All subjects enrolled and had a response assessment are included in the outcome measure below. | Posted | Number | participants | From enrollment to Surgery |
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Histopathologic Tumor Response | Estimate the rate of good histopathologic response as the proportion of grade I and II responders. The analysis population for this objective is the ITT population. Any patient for whom a surgical sample is not available will be considered a poor-responder. | Only subjects who had surgery were included in this outcome measure. | Posted | Number | grade II responder | at the time of surgery |
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Time to Recurrence: | Time to recurrence is defined as the time from surgical resection to disease recurrence or death from any cause. Patients who have not recurred at the end of follow up will have their recurrence time censored at the last date of contact. | The study terminated early, prior to the follow up period being completed. Only one subject had surgery and that subject is still alive at the time of study termination, so time to recurrence cannot be estimated. | Posted | 2 years |
|
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| Secondary | Overall Survival: | Overall survival is defined as the time from enrollment to death from any cause. Patients still alive at the end of follow up will have their survival time censored at the last date of contact. | The study terminated early, prior to the end of the follow up period for all subjects. At the time of study termination, one subject had expired and the time from enrollment to death for that subject is reported below. | Posted | Number | days | 2 years |
|
| ||||||||||||||||||||||||||||||||||
| Other Pre-specified | Feasibility Objective | The feasibility of treating patients with localized pancreatic head adenocarcinoma with this neoadjuvant regimen will be evaluated by estimating the proportion of patients completing five of six planned doses. The analysis population will be the ITT population. | The number of subjects who had 5-6 doses of neoadjuvant regimen | Posted | Number | participants | From enrollment to end of chemotherapy part of the study |
|
| ||||||||||||||||||||||||||||||||||
| Other Pre-specified | CTC Analysis | To evaluate and describe CTC numbers, CTC phenotype characteristics and effectiveness/rate of CTC culturing techniques from patients with pancreatic adenocarcinoma. | The CTC analysis was added as an amendment. No subjects were enrolled to the study after this amendment was approved, so data for this outcome was not collected or analyzed. | Posted | End of study |
|
| ||||||||||||||||||||||||||||||||||||
| Other Pre-specified | CTC Expression | To determine and evaluate the correlation between expression or biomarkers in the CTCs and expression of biomarkers in resected tissue specimens within the same cancer patient. | The CTC expression endpoint was added as an amendment. No subjects were enrolled to the study after this amendment was approved, so data for this outcome was not collected or analyzed. | Posted | 2 years |
|
|
Start of treatment to end of treatment.
AEs are reported from the start of chemotherapy to the end of study treatment. Any medically significant AEs, which are ongoing at the end of study treatment should be followed until the event is resolved or considered stable.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Chemotherapy, Chemoradiation, Surgery | Neoadjuvant chemotherapy - modified FOLFIRINOX chemotherapy Day and and Day 15 of 28 days cycles for 3 cycles with growth factor support followed by chemoradiation for 6-8 weeks, then surgical resection | 2 | 3 | 3 | 3 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| bile duct stenosis | Hepatobiliary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| abdominal pain | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| chills | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| fever | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| anemia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| leukocytosis | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
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| ear infection | Ear and labyrinth disorders | CTCAE (4.0) | Systematic Assessment |
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| diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| nausea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| vomiting | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| fatigue | General disorders | CTCAE (4.0) | Systematic Assessment |
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| chills | General disorders | CTCAE (4.0) | Systematic Assessment |
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| fever | General disorders | CTCAE (4.0) | Systematic Assessment |
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| pain | General disorders | CTCAE (4.0) | Systematic Assessment |
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| non-cardiac chest pain | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| ALT increased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| alkaline phosphatase increase | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| AST increased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| blood bilirubin increase | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| abnormal appetite | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| hyperglycemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| hypoalbuminemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| hypokalemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| dizziness | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| syncope | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| anxiety | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
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| insomnia | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
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| dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| hiccups | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| ECRP | Surgical and medical procedures | CTCAE (4.0) | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Paul O'Brien, MD | Medical University of South Carolina | 843-792-4271 | obrienpe@musc.edu |
| ID | Term |
|---|---|
| D059248 | Chemoradiotherapy |
| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
| D011878 | Radiotherapy |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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