Trial Outcomes & Findings for Effects of Folfirinox and Stereotactic Body Radiation Therapy for Advanced Pancreatic Cancer (NCT NCT02128100)

Last Updated: 2024-03-05

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

5 participants

Primary outcome timeframe

Assessed up to 24 months post treatment

Results posted on

2024-03-05

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	5
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effects of Folfirinox and Stereotactic Body Radiation Therapy for Advanced Pancreatic Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Folririnox With SBRT n=5 Participants 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants
Age, Continuous	68 years STANDARD_DEVIATION 5 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	5 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Folririnox With SBRT n=5 Participants 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.
Grade 3 or Higher Adverse Event(s) as a Measure of Safety and Tolerability	3 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Folririnox With SBRT n=4 Participants 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.
Overall Response Rate for Participants as Assessed by Contrast-enhanced CT Scan of the Abdomen at 12 Months.	2 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Folririnox With SBRT n=4 Participants 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.
Quality of Life Assessment at 12 Months Post-treatment	115 score on a scale Standard Deviation 12

Adverse Events

Folririnox With SBRT

Serious events: 0 serious events

Other events: 4 other events

Deaths: 3 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Folririnox With SBRT n=5 participants at risk 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.
Metabolism and nutrition disorders Hypokalemia	20.0% 1/5 • 24 months
Skin and subcutaneous tissue disorders Hand-foot syndrome	60.0% 3/5 • 24 months

Additional Information

Dr. Neal Dunlap

University of Louisville

Phone: 502-561-2700

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place