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

NCT ID: NCT02128100

Last Updated: 2024-03-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-19
• Study Completion Date: 2021-03-15

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.

Conditions

Pancreatic Cancer Non-resectable

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Folfirinox

Intervention Type: DRUG

• 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

Intervention Type: RADIATION

5 treatments of stereotactic ablative radiotherapy (SABR) over the course of two weeks with a minimum of 36 hours in between each treatment.

Interventions

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

Intervention Type: DRUG

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.

Intervention Type: RADIATION

Other Intervention Names

o Oxaliplatin; o Leucovorin; o Irinotecan; o Fluorouracil

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

James Graham Brown Cancer Center

OTHER

Sponsor Role: collaborator

University of Louisville

OTHER

Sponsor Role: lead

Responsible Party

Neal Edward Dunlap

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Neal E Dunlap, MD

Role: PRINCIPAL_INVESTIGATOR

James Graham Brown Cancer Center

Locations

James Graham Brown Cancer Center

Louisville, Kentucky, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

14.0413

Identifier Type: -

Identifier Source: org_study_id