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

University of Louisville (UOFL)

Status and phase: Completed; Phase 2

Conditions: Pancreatic Cancer Non-resectable

Treatments: Drug: Folfirinox; Radiation: Stereotactic Body Radiation Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02128100

14.0413

Details and patient eligibility

About

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.

Full 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.

Enrollment: 5 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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5 participants in 1 patient group

Folririnox with SBRT

Experimental group

Description:

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.

Treatment:

Drug: Folfirinox

Radiation: Stereotactic Body Radiation Therapy