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To evaluate the safety and effectiveness of a novel neoadjuvant treatment strategy incorporating 5-fluorouracil/leucovorin with oxaliplatin ( FOLFOX )chemotherapy in combination with chemo-radiation with gemcitabine.
The primary objective is to evaluate frequency of achieving complete resection ( RO resection )in patients with resectable and borderline resectable pancreatic cancer treated with a neoadjuvant regimen of FOLFOX followed by radiation therapy (RT) concurrent with gemcitabine chemotherapy at standard dosing.
Secondary objectives are to determine overall survival and progression-free survival as a function of time from study enrollment and to evaluate tolerability and toxicity of protocol treatment.
Eligible patients with resectable and borderline resectable pancreatic cancer will be accrued onto protocol therapy, which would include a neo-adjuvant phase followed by surgical resection. A cycle of FOLFOX treatment is 14 days. 2 cycles are intended prior to combined modality treatment. Combined modality treatment will begin 2 weeks (plus or minus 2 days) after the last FOLFOX administration. (Gemcitabine 1000mg/m² will be infused over 30 minutes on days 1, 8, 22, and 29 during the 5-week course of radiation treatment. The surgical procedure performed will be that required for a complete resection, and this will be based on the discretion of the operating surgeon. Patients will be followed for 1 year after completion of neoadjuvant therapy or until removal or termination from study, or until death, whichever occurs first. Patients will be seen in follow-up ever 3+/- 1 months for 1 year from completion of protocol therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neoadjuvant Chemo-Radiotherapy and Resection | Experimental | 2 cycles - FOLFOX6 (1 month) Gemcitabine/RT (5-6 weeks) Rest period 2 weeks Re-staging evaluation (CT scan to be done during the 2 weeks of rest) Surgery (To be performed no later than 6 weeks after completion of chemo-radiation) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Folfox6 | Drug |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of R0 Resection | Evaluate frequency of achieving R0 resection in patients with resectable and borderline resectable pancreatic cancer treated with a neoadjuvant regimen of FOLFOX followed by RT concurrent with gemcitabine chemotherapy at standard dosing | 6 weeks |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gazala Khan, MD | Henry Ford Health System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henry Ford Health System | Detroit | Michigan | 48202 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32251119 | Result | Thanikachalam K, Damarla V, Seixas T, Dobrosotskaya I, Wollner I, Kwon D, Winters K, Raoufi M, Li J, Siddiqui F, Khan G. Neoadjuvant Phase II Trial of Chemoradiotherapy in Patients With Resectable and Borderline Resectable Pancreatic Cancer. Am J Clin Oncol. 2020 Jun;43(6):435-441. doi: 10.1097/COC.0000000000000688. |
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Through publication in peer reviewed journal
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| ID | Title | Description |
|---|---|---|
| FG000 | Neoadjuvant Chemo-Radiotherapy and Resection | 2 cycles - FOLFOX6 (1 month) Gemcitabine/RT (5-6 weeks) Rest period 2 weeks Re-staging evaluation (CT scan to be done during the 2 weeks of rest) Surgery (To be performed no later than 6 weeks after completion of chemo-radiation) Folfox6 Gemcitabine Radiation Therapy Pancreaticoduodenectomy with retroperitoneal lymphadenectomy |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 11, 2013 |
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| Gemcitabine |
| Drug |
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| Radiation Therapy | Radiation |
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| Pancreaticoduodenectomy with retroperitoneal lymphadenectomy | Procedure |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Neoadjuvant Chemo-Radiotherapy and Resection | 2 cycles - FOLFOX6 (1 month) Gemcitabine/RT (5-6 weeks) Rest period 2 weeks Re-staging evaluation (CT scan to be done during the 2 weeks of rest) Surgery (To be performed no later than 6 weeks after completion of chemo-radiation) Folfox6 Gemcitabine Radiation Therapy Pancreaticoduodenectomy with retroperitoneal lymphadenectomy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Full Range | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race/Ethnicity, Customized | 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 | Frequency of R0 Resection | Evaluate frequency of achieving R0 resection in patients with resectable and borderline resectable pancreatic cancer treated with a neoadjuvant regimen of FOLFOX followed by RT concurrent with gemcitabine chemotherapy at standard dosing | 13 patients underwent pancreatectomy after completion of neoadjuvant CRT | Posted | Count of Participants | Participants | 6 weeks |
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Consent to 1 year post completion of protocol therapy
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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 | Neoadjuvant Chemo-Radiotherapy and Resection | 2 cycles - FOLFOX6 (1 month) Gemcitabine/RT (5-6 weeks) Rest period 2 weeks Re-staging evaluation (CT scan to be done during the 2 weeks of rest) Surgery (To be performed no later than 6 weeks after completion of chemo-radiation) Folfox6 Gemcitabine Radiation Therapy Pancreaticoduodenectomy with retroperitoneal lymphadenectomy | 0 | 24 | 0 | 24 | 21 | 24 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Fatigue | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Decreased appetite | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Hypokalemia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Neuropathy | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Mucositis | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Hypomagnesemia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Cold intolerance | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Abdominal pain | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Gazala Khan, MD | Henry Ford Cancer Institute | 313-598-2860 | gkhan1@hfhs.org |
| Sep 1, 2023 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C410216 | Folfox protocol |
| C029269 | 5-fluoropyrimidine |
| D000093542 | Gemcitabine |
| D011878 | Radiotherapy |
| D016577 | Pancreaticoduodenectomy |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D013812 | Therapeutics |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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| Hispanic |
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| Other |
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