Pancreatic Cancer Non-resectable
Conditions
Keywords
Pancreatic Cancer
Brief summary
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.
Detailed description
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.
Interventions
DRUGFolfirinox
* 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
RADIATIONStereotactic 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.
Sponsors
James Graham Brown Cancer Center
University of Louisville
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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: * CT scan of the chest, abdomen and pelvis with IV and oral contrast within 8 weeks of registration * Whole body PET scan within 8 weeks of registration * 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: * ANC \> 1,500 cell/mm3 * Platelets \> 100,000 cells/mm3 * Hemoglobin \> 8.0 g/dl (transfusion to obtain this value is permissible) * Additional labs within 14 days prior to registration * CA 19-9 * Creatinine \<2mg/dl * Bilirubin \<2mg/dl * AST and ALT \< 2.5 x ULN * Patients must provide study specific informed consent prior to study entry.
Exclusion criteria
* Metastatic disease as defined by the multi-disciplinary team * Prior anti-cancer therapy for a pancreatic tumor * Prior malignancy within the last 3 years. * Pregnant women or lactating women * Acquired Immune Deficiency Syndrome (AIDS) based on CDC criteria. However HIV testing is not manditory for this protocol * Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Grade 3 or Higher Adverse Event(s) as a Measure of Safety and Tolerability | Assessed up to 24 months post treatment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Response Rate for Participants as Assessed by Contrast-enhanced CT Scan of the Abdomen at 12 Months. | Assessed at 3 months, 6 months, 9 months and 12 months post-treatment | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life Assessment at 12 Months Post-treatment | 12 months from completion of therapy | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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: o 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. | 5 |
| Total | 5 |
Baseline characteristics
| Characteristic | Folririnox With SBRT |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 4 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants |
| Age, Continuous | 68 years STANDARD_DEVIATION 5 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 5 Participants |
| Region of Enrollment United States | 5 participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 3 / 5 |
| other Total, other adverse events | 4 / 5 |
| serious Total, serious adverse events | 0 / 5 |
Outcome results
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.
Time frame: Assessed up to 24 months post treatment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Folririnox With SBRT | Grade 3 or Higher Adverse Event(s) as a Measure of Safety and Tolerability | 3 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.
Time frame: Assessed at 3 months, 6 months, 9 months and 12 months post-treatment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Folririnox With SBRT | Overall Response Rate for Participants as Assessed by Contrast-enhanced CT Scan of the Abdomen at 12 Months. | 2 Participants |
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.
Time frame: 12 months from completion of therapy
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Folririnox With SBRT | Quality of Life Assessment at 12 Months Post-treatment | 115 score on a scale | Standard Deviation 12 |