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Study team felt toxicity of study regimen outweighed potential benefit.
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Patients diagnosed with pancreatic cancer without clinically detectable metastatic disease will be treated with standardized systemic chemotherapy, followed by chemoradiation, and then surgical resection for those with resectable or borderline resectable disease. The primary endpoint is disease-free survival at 1 yr from initiation of treatment.
Patients with ductal adenocarcinoma of the pancreas (or ampulla) that have received no prior therapy and have no clinically detectable metastatic disease will be enrolled. Management will be driven by resectability status as defined by the American College of Surgeons. All patients will be defined at entry as Resectable, Borderline Resectable or Locally Advanced (Unresectable).
All patients will be treated initially with gemcitabine and nanoparticle albumin bound paclitaxel (nab-paclitaxel) every 14 days for 4 cycles. Patients classified as Resectable, who have CA19-9 below 180 and CA-125 below 30 will then proceed to resection. All other patients will get 5-fluorouracil as 46 hr infusion given with leucovorin and irinotecan (FOLFIRI-3) every 14 days x 4 cycles.
All patients without progression will then receive chemoradiation consisting of external beam radiotherapy (40 Gy in 20 fractions given over 4 weeks). During radiation all patients will receive radiosensitizing radiotherapy as: 5-fluorouracil at 225 mg/m2 5 days per week, Mitomycin-C at 3 mg.m2 on d1, 8, 15 & 22; Cisplatin at 10 mg/m2 on d2, 9, 16, 23 and unfractionated heparin at 6,000 units/m2 daily in divided doses from day 1 to day 28.
After approximately 4 weeks to recover from chemoradiation, all patients with Resectable or Borderline Resectable disease will undergo definitive surgery.
Adjuvant therapy with FOLFIR-3 for an additional 6 cycles will be offered to all patients post-operatively.
Patients will then be actively followed every 3 to 6 months in keeping with National Comprehensive Cancer Network (NCCN) guidelines for 2 yrs, and then followed for recurrence, late toxicity and vital status every 6 months through 5 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Resectable, Low Risk | Experimental | Systemic chemotherapy followed by definitive surgery without pre-operative or post-operative radiotherapy. |
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| Locally Advanced | Experimental | Systemic chemotherapy followed by chemoradiation, followed by definitive surgery |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gemcitabine and nanoparticle albumin bound paclitaxel | Drug | Gemcitabine and nab-paclitaxel given every 14 days x 4 cycles |
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| Measure | Description | Time Frame |
|---|---|---|
| Relapse Free Survival | Percentage of patients alive and free of detectable disease 1 yr from start of treatment | 1 yr form onset of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| R-0 Rate | Rate of patients having surgery who have negative surgical margins (i.e. R-0 resection) | Time of surgery |
| Overall Survival | Time to death from any cause measured from start of treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter Kebbekus, MD, PhD | Essentia Health Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Essentia Health Cancer Center | Duluth | Minnesota | 55805 | United States |
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| ID | Type | URL | Comment |
|---|---|---|---|
| Study Protocol | View IPD |
We will make unidentified dataset available for electronic download.
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| ID | Title | Description |
|---|---|---|
| FG000 | Resectable, Low Risk | Systemic chemotherapy followed by definitive surgery without pre-operative or post-operative radiotherapy. Gemcitabine and nanoparticle albumin bound paclitaxel: Gemcitabine and nab-paclitaxel given every 14 days x 4 cycles Definitive resection: Definitive surgical resection of primary tumor |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| 5-fluorouracil and irinotecan | Drug | FOLFIRI.3 given every 14 days x 4 cycles |
|
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| Preoperative chemoradiation | Radiation | Pre-operative chemoradiation to 40 Gy in 20 fractions |
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| Definitive resection | Procedure | Definitive surgical resection of primary tumor |
|
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| Up to 3 years from registration |
| Locally Advanced |
Systemic chemotherapy followed by chemoradiation, followed by definitive surgery Gemcitabine and nanoparticle albumin bound paclitaxel: Gemcitabine and nab-paclitaxel given every 14 days x 4 cycles 5-fluorouracil and irinotecan: FOLFIRI.3 given every 14 days x 4 cycles Preoperative chemoradiation: Pre-operative chemoradiation to 40 Gy in 20 fractions Definitive resection: Definitive surgical resection of primary tumor |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Resectable, Low Risk | Systemic chemotherapy followed by definitive surgery without pre-operative or post-operative radiotherapy. Gemcitabine and nanoparticle albumin bound paclitaxel: Gemcitabine and nab-paclitaxel given every 14 days x 4 cycles Definitive resection: Definitive surgical resection of primary tumor |
| BG001 | Locally Advanced | Systemic chemotherapy followed by chemoradiation, followed by definitive surgery Gemcitabine and nanoparticle albumin bound paclitaxel: Gemcitabine and nab-paclitaxel given every 14 days x 4 cycles 5-fluorouracil and irinotecan: FOLFIRI.3 given every 14 days x 4 cycles Preoperative chemoradiation: Pre-operative chemoradiation to 40 Gy in 20 fractions Definitive resection: Definitive surgical resection of primary tumor |
| BG002 | Total | Total of all reporting groups |
| 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 |
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| Age, Continuous | Median | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
| |||||||||||||||
| Region of Enrollment | Number | 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 | Relapse Free Survival | Percentage of patients alive and free of detectable disease 1 yr from start of treatment | Due to excessive toxicity of study regimen, the study was permanently closed prior to data analysis. | Posted | 1 yr form onset of treatment |
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| ||||||||||||||||||||||
| Secondary | R-0 Rate | Rate of patients having surgery who have negative surgical margins (i.e. R-0 resection) | Data not collected, study Terminated | Posted | Time of surgery |
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| ||||||||||||||||||||||
| Secondary | Overall Survival | Time to death from any cause measured from start of treatment | Data not collected, study terminated | Posted | Up to 3 years from registration |
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Study enrollment through study termination, on average approximately 3 months
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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 | Resectable, Low Risk | Systemic chemotherapy followed by definitive surgery without pre-operative or post-operative radiotherapy. Gemcitabine and nanoparticle albumin bound paclitaxel: Gemcitabine and nab-paclitaxel given every 14 days x 4 cycles Definitive resection: Definitive surgical resection of primary tumor | 0 | 1 | 0 | 1 | 0 | 1 |
| EG001 | Locally Advanced | Systemic chemotherapy followed by chemoradiation, followed by definitive surgery Gemcitabine and nanoparticle albumin bound paclitaxel: Gemcitabine and nab-paclitaxel given every 14 days x 4 cycles 5-fluorouracil and irinotecan: FOLFIRI.3 given every 14 days x 4 cycles Preoperative chemoradiation: Pre-operative chemoradiation to 40 Gy in 20 fractions Definitive resection: Definitive surgical resection of primary tumor | 1 | 10 | 3 | 10 | 2 | 10 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| diarrhea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| diarrhea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Bret Friday | Essentia Health | 218-786-3625 | bret.friday@essentiahealth.org |
| ID | Term |
|---|---|
| D000093542 | Gemcitabine |
| D013660 | Taxes |
| D005472 | Fluorouracil |
| D000077146 | Irinotecan |
| D016577 | Pancreaticoduodenectomy |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D004467 | Economics |
| D004472 | Health Care Economics and Organizations |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D002166 | Camptothecin |
| D000470 | Alkaloids |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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| Between 18 and 65 years |
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| >=65 years |
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