drugset / Trial / NCT03099265

Neoadjuvant Modified FOLFIRINOX and Stereotactic Body Radiation Therapy in Borderline Resectable Pancreatic Adenocarcinoma

NCT03099265 ↗

Phase 2 Terminated 9 enrolled Yale University
NaSingle-groupOpen-labelTreatment

Summary

Surgical resection is the only potentially curative treatment for patients with pancreatic cancer. Patients with BRPC have tumors in close contact with the vasculature but not to the extent that resection is prohibited. Nonetheless, retrospective studies have shown that immediate resection in these patients is associated with an increased risk of positive margins, and a margin positive resection does not improve survival over that of patients with unresectable disease. Moreover, even in those patients where a successful resection is achieved, there is a high rate of early metastatic progression suggesting that micrometastatic disease is often present at diagnosis. Therefore neoadjuvant therapy is likely to improve outcomes in patients with BRPC to increase the likelihood of achieving a margin negative resection, provide early control of occult micrometastatic disease, and select those patients without systemic progression who would benefit from surgical resection.

Timeline

Start
2017-06-26
Primary completion
2019-09-18
Completion
2019-09-18

Outcome

Outcome not reported

Stopped: “Paused due to COVID. A determination was made to stop the study because it would be impossible to reach the 65% resection rate as outlined in the protocol.”

Drugs

EvaluationDrugModalityDoseRoute
Subject Irinotecan Small molecule 135 mg/m2 Intravenous
Subject Leucovorin Small molecule 200 mg/m2 Intravenous
Subject Leucovorin Small molecule 400 mg/m2 Intravenous
Subject Oxaliplatin Small molecule 85 mg/m2 —
Subject fluorouracil Small molecule 300 mg/m2 Intravenous
Subject fluorouracil Small molecule 2400 mg/m2 Intravenous