BCC-RAD-13: Effects of Folfirinox and Stereotactic Body Radiation Therapy for Advanced Pancreatic Cancer

Sponsor

University of Louisville (Other)

Overall Status

Recruiting

CT.gov ID

NCT02128100

Collaborator

James Graham Brown Cancer Center (Other)

Enrollment

Locations

Arm

132

Duration (Months)

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pancreatic Cancer Non-resectable	Drug: Folfirinox Radiation: Stereotactic Body Radiation Therapy	Phase 2

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

28 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

The Effect of FOLFIRINOX and Stereotactic Body Radiation Therapy for Locally Advanced, Non-Resectable Pancreatic Cancer

Study Start Date :

May 1, 2014

Anticipated Primary Completion Date :

May 1, 2025

Anticipated Study Completion Date :

May 1, 2025

Arms and Interventions

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 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.	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 infusion over 46 hours Other Names: o Oxaliplatin o Leucovorin o Irinotecan o Fluorouracil 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.

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 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.

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 infusion over 46 hours

Other Names:

o Oxaliplatin

o Leucovorin

o Irinotecan

o Fluorouracil

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.

Outcome Measures

Primary Outcome Measures

Number of Participants with Adverse Event(s) as a Measure of Safety and Tolerability [Assessed up to 24 months post treatment]

Secondary Outcome Measures

Overall Response Rate for Participants [Assessed at 3 months, 6 months, 9 months and 12 months post-treatment]

Other Outcome Measures

Quality of Life Assessment [Within 6 weeks of treatment and at 3 month intervals post-treatment up to 24 months.]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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