Effects Of Folfirinox And Stereotactic Body Radiation Therapy For Advanced Pancreatic Cancer

Study Overview

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

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.

Pancreatic Cancer Non-resectable

DRUG: Folfirinox
RADIATION: Stereotactic Body Radiation Therapy

14.0413

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2014-04-22	Results First Submitted 2022-03-11	Last Update Submitted that met QC Criteria 2024-02-06
First Submitted that Met QC Criteria 2014-04-30	Results First Submitted that Met QC Criteria 2024-02-06	Last Update Posted (ACTUAL) 2024-03-05
First Posted (ACTUAL) 2014-05-01	Results First Posted 2024-03-05	Last Verified 2024-02

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: 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	DRUG: 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 i RADIATION: 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.

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: 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

DRUG: 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 i

RADIATION: 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.

Primary Outcome Measures	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

Secondary Outcome Measures	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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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.

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

James Graham Brown Cancer Center

Investigators

PRINCIPAL_INVESTIGATOR: Neal E Dunlap, MD, James Graham Brown Cancer Center

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

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Clinical Trial Record