Borderline Pancreas Study: FOLFIRINOX +SBRT

• Status: Completed
• Trial end date: 2018-09-27
• Target enrollment: 0
• Participant gender: All

Summary

Primary Objective: To determine the rate of downstaging to resectability in patients with borderline resectable pancreatic cancer receiving FOLFIRINOX and SBRT as preoperative therapy.

Secondary Objective(s):

1. To assess the disease-free-survival, overall survival, time to recurrence and site of recurrence in patients with borderline resectable pancreatic cancer receiving preoperative FOLFIRINOX followed by SBRT

2. To investigate the safety and tolerability of FOLFIRINOX and SBRT in patients with resectable pancreatic cancer

3. To determine the radiologic and pathological response associated with preoperative SBRT and FOLFIRINOX therapy

4. To assess quality of life through and after treatment using the FACT-Hep questionnaire

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Maryland; University of Maryland, Baltimore
• Treatments: Fluorouracil; Folfirinox; Irinotecan; Oxaliplatin

Criteria

Inclusion Criteria:

• ≥ 18 years at diagnosis.

• Biopsy proven pancreatic adenocarcinoma.

• Borderline resectable per NCCN criteria (No distant metastases, venous involvement of the portal vein/SMV, demonstrating tumor abutment and narrowing of the lumen, encasement of the portal vein/SMV without encasement of the nearby arteries, or short-segment venous occlusion resulting from either tumor thrombus or encasement but with suitable vessel proximal or distal to this area of vessel involvement, allowing for safe resection and reconstruction; gastroduodenal artery encasement up to the hepatic artery with either short segment encasement or direct abutment of the hepatic artery, without extension to the celiac axis; tumor abutment of the SMA not to exceed 180 degrees of the circumference of the vessel wall.).

• Radiologically measurable or clinically evaluable disease.

• Pancreas protocol CT and/or MRI if required for further clarification of disease tissue planes within 4 weeks of registration.

• ECOG PS of 0-2.

• Able to get a Whipple resection per surgeon assessment performed within 4 weeks of registration.

• The following laboratory values obtained ≤ 28 days prior to registration:

• Absolute neutrophil count (ANC) ≥ 1,500/mm3.

• Platelet count ≥ 100,000/mm3.

• Hemoglobin > 8.0 g/dL.

• Total bilirubin ≤ 1.5 x upper limit of normal (ULN).

• SGOT (AST) ≤ 2 x ULN.

• SGPT (ALT) ≤ 2 x ULN.

• Creatinine ≤ 1.5 x ULN.

• CA 19-9 level (to establish baseline).

• A negative pregnancy test within 7 days prior to registration for women of childbearing potential. In addition, male and female participants must commit to adequate contraception while on study.

• Able to provide written informed consent.

• Willing to return for all required study assessments.

• Neurological assessment for pre-existing peripheral neuropathy.

• Documentation of pre-existing hearing deficits.

Exclusion Criteria:

• Any pancreatic adenocarcinoma that does not meet criteria for borderline resectable disease.

• Prior history of abdominal radiation therapy.

• History of autoimmune disease such as scleroderma, lupus, and inflammatory bowel disease.

• Patients with tumor-caused symptomatic bowel obstruction.

• Chemotherapy (including hormonal therapy) within the past 5 years from date of registration.

• Other invasive malignancies within the past 5 years from date of registration.

• Pregnant or nursing women or women of childbearing age that are unwilling to employ adequate contraception.

• Other co-morbid conditions which, based on the judgment of the physicians obtaining informed consent, would make the patient inappropriate for this study.