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| Name | Class |
|---|---|
| James Graham Brown Cancer Center | OTHER |
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This study wants to find out how safe and effective the use of Folfirinox combined with Stereotactic Body Radiation Therapy )(SBRT) is for the treatment of pancreatic cancer.
The study will be a prospective, non-randomized, single center, trial to assess the effects of FOLIRINOX chemotherapy with SBRT on locally advanced, non-resectable pancreatic cancer. Patients will either undergo a biopsy to confirm the diagnosis or have strong clinical suspicion of a new cancer or recurrence based on the recommendations of a multi-disciplinary GI oncology team. FOLFIRINOX with be delivered prior to SBRT for 4 cycles. Restaging imaging will occur prior to SBRT delivery. SBRT will be delivered using standard stereotactic techniques to a dose of 3200cGy at 650cGy per fraction delivered over 2 weeks. Additional adjuvant chemotherapy with be delivered at the physician's discretion. Patients will be reassessed both clinically and radiographically at 3 months, 6 months, 9 months and 12 months post-treatment. Quality of life analysis will occur at 3 month intervals after treatment. Blood will be drawn for exploratory biomarker analysis at strategic timepoints during treatment and followup. Following the initial imaging time points, standard surveillance will be employed with clinical assessment and imaging at 3 month intervals for the first 2 years post-treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Folririnox with SBRT | Experimental | Folfirinox
SBRT 5 treatments of stereotactic body radiation therapy (SBRT) over the course of two weeks with a minimum of 36 hours in between each treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Folfirinox | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Grade 3 or Higher Adverse Event(s) as a Measure of Safety and Tolerability | Number of Participants With Grade 3 or Higher Adverse Event(s) as a Measure of Safety and Tolerability. This is based on CTCAE to assess toxicity at specified time points by the treating physician. | Assessed up to 24 months post treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate for Participants as Assessed by Contrast-enhanced CT Scan of the Abdomen at 12 Months. | Response to therapy at 12 months post treatment as measured from CT Scan by modified RECIST criteria as follows; Response is measured as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum of LD. | Assessed at 3 months, 6 months, 9 months and 12 months post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life Assessment at 12 Months Post-treatment | Assessment is based on participant results from administration of the Functional Assessment of Cancer Therapy - Pancreas (FACT-Hep). FACT-Hep is an established tool for measuring quality of life both before and after intervention. The form consists of 45 questions and should take approximately 8 minutes to complete. Higher scores indicate higher quality of life. This assessment consists of the following sub-scales (with associated score ranges): Physical Well-Being (0-28); Social/Family Well-Being (0-28); Emotional Well-Being (0-24); Functional Well-Being (0-28); Hepatobiliary Cancer (0-72). All items are ranked on a five-point scale ranging from 0-4. Results were based on the mean FACT-G total score of all participants. The FACT-G total score is derived from the sum of scores on the Physical, Emotional, Social/Family, Functional Well-Being and Hepatobiliary Cancer subscales and is designed to measure Health Related Quality of Life (HRQOL) in subjects undergoing cancer treatment. |
Inclusion Criteria:
Age >/= 18 years
ECOG performance status 0-1
Pathologic or clinical diagnosis of a new pancreatic adenocarcinoma. A reasonable attempt should be made to make a pathologic diagnosis of malignancy.
Imaging as follows:
Evaluation by a surgical oncologist to determine non-resectability
Negative serum pregnancy test within 2 weeks prior to registration for women of childbearing potential.
CBC/differential obtained within 14 days prior to registration with adequate bone marrow function as follows:
Additional labs within 14 days prior to registration
Patients must provide study specific informed consent prior to study entry.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Neal E Dunlap, MD | James Graham Brown Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| James Graham Brown Cancer Center | Louisville | Kentucky | 40202 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Folririnox With SBRT | Folfirinox Oxaliplatin 85 mg/m² for over 2 hours, Leucovorin 400n mg/m² for over 2 hours, Irinotecan 180 mg/m² for over 90 minutes, along with Leucovorin infusion Fluorouracil 400 mg/m² as a fast infusion over 15 minutes Fluorouracil 2400 mg/m² as a slow infusion over 46 hours SBRT 5 treatments of stereotactic body radiation therapy (SBRT) over the course of two weeks with a minimum of 36 hours in between each treatment. Folfirinox: Oxaliplatin 85 mg/m² for over 2 hours, Leucovorin 400n mg/m² for over 2 hours, Irinotecan 180 mg/m² for over 90 minutes, along with Leucovorin infusion Fluorouracil 400 mg/m² as a fast infusion over 15 minutes Fluorouracil 2400 mg/m² as a slow infusion over 46 hours Stereotactic Body Radiation Therapy: 5 treatments of stereotactic ablative radiotherapy (SABR) over the course of two weeks with a minimum of 36 hours in between each treatment. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Folririnox With SBRT | Folfirinox
SBRT 5 treatments of stereotactic body radiation therapy (SBRT) over the course of two weeks with a minimum of 36 hours in between each treatment. Folfirinox: o Oxaliplatin 85 mg/m² for over 2 hours,
Stereotactic Body Radiation Therapy: 5 treatments of stereotactic ablative radiotherapy (SABR) over the course of two weeks with a minimum of 36 hours in between each treatment. |
| 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 |
| 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 | Grade 3 or Higher Adverse Event(s) as a Measure of Safety and Tolerability | Number of Participants With Grade 3 or Higher Adverse Event(s) as a Measure of Safety and Tolerability. This is based on CTCAE to assess toxicity at specified time points by the treating physician. | Posted | Count of Participants | Participants | Assessed up to 24 months post treatment |
|
24 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 | Folririnox With SBRT | Folfirinox
SBRT 5 treatments of stereotactic body radiation therapy (SBRT) over the course of two weeks with a minimum of 36 hours in between each treatment. Folfirinox: o Oxaliplatin 85 mg/m² for over 2 hours,
Stereotactic Body Radiation Therapy: 5 treatments of stereotactic ablative radiotherapy (SABR) over the course of two weeks with a minimum of 36 hours in between each treatment. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypokalemia | Metabolism and nutrition disorders | Systematic Assessment | CTCAE grade 1 = 1 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Neal Dunlap | University of Louisville | 502-561-2700 | neal.dunlap@louisville.edu |
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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 | Sep 10, 2015 | Sep 16, 2021 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 15, 2018 | Sep 16, 2021 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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| ID | Term |
|---|---|
| C000627770 | folfirinox |
| D016634 | Radiosurgery |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D013238 | Stereotaxic Techniques |
| D019635 | Neurosurgical Procedures |
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|
|
| Stereotactic Body Radiation Therapy | Radiation | 5 treatments of stereotactic ablative radiotherapy (SABR) over the course of two weeks with a minimum of 36 hours in between each treatment. |
|
| 12 months from completion of therapy |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Overall Response Rate for Participants as Assessed by Contrast-enhanced CT Scan of the Abdomen at 12 Months. | Response to therapy at 12 months post treatment as measured from CT Scan by modified RECIST criteria as follows; Response is measured as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum of LD. | Posted | Count of Participants | Participants | Assessed at 3 months, 6 months, 9 months and 12 months post-treatment |
|
|
|
| Other Pre-specified | Quality of Life Assessment at 12 Months Post-treatment | Assessment is based on participant results from administration of the Functional Assessment of Cancer Therapy - Pancreas (FACT-Hep). FACT-Hep is an established tool for measuring quality of life both before and after intervention. The form consists of 45 questions and should take approximately 8 minutes to complete. Higher scores indicate higher quality of life. This assessment consists of the following sub-scales (with associated score ranges): Physical Well-Being (0-28); Social/Family Well-Being (0-28); Emotional Well-Being (0-24); Functional Well-Being (0-28); Hepatobiliary Cancer (0-72). All items are ranked on a five-point scale ranging from 0-4. Results were based on the mean FACT-G total score of all participants. The FACT-G total score is derived from the sum of scores on the Physical, Emotional, Social/Family, Functional Well-Being and Hepatobiliary Cancer subscales and is designed to measure Health Related Quality of Life (HRQOL) in subjects undergoing cancer treatment. | Posted | Mean | Standard Deviation | score on a scale | 12 months from completion of therapy |
|
|
|
| 3 |
| 5 |
| 0 |
| 5 |
| 4 |
| 5 |
| Hand-foot syndrome | Skin and subcutaneous tissue disorders | Systematic Assessment | CTCAE grade 1 = 2 patients, grade 2 = 1 patient (all resolved) |
|
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| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D013514 |
| Surgical Procedures, Operative |
| D008919 | Investigative Techniques |