NCT02243358

Phase II Study of Chemo-Radiotherapy in Patients With Resectable and Borderline Resectable Pancreatic Cancer

A Neoadjuvant Phase II Study of Chemo-Radiotherapy in Patients With Resectable and Borderline Resectable Pancreatic Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Henry Ford Health System · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the safety and effectiveness of a novel neoadjuvant treatment strategy incorporating 5-fluorouracil/leucovorin with oxaliplatin ( FOLFOX )chemotherapy in combination with chemo-radiation with gemcitabine.

Detailed description

The primary objective is to evaluate frequency of achieving complete resection ( RO resection )in patients with resectable and borderline resectable pancreatic cancer treated with a neoadjuvant regimen of FOLFOX followed by radiation therapy (RT) concurrent with gemcitabine chemotherapy at standard dosing. Secondary objectives are to determine overall survival and progression-free survival as a function of time from study enrollment and to evaluate tolerability and toxicity of protocol treatment. Eligible patients with resectable and borderline resectable pancreatic cancer will be accrued onto protocol therapy, which would include a neo-adjuvant phase followed by surgical resection. A cycle of FOLFOX treatment is 14 days. 2 cycles are intended prior to combined modality treatment. Combined modality treatment will begin 2 weeks (plus or minus 2 days) after the last FOLFOX administration. (Gemcitabine 1000mg/m² will be infused over 30 minutes on days 1, 8, 22, and 29 during the 5-week course of radiation treatment. The surgical procedure performed will be that required for a complete resection, and this will be based on the discretion of the operating surgeon. Patients will be followed for 1 year after completion of neoadjuvant therapy or until removal or termination from study, or until death, whichever occurs first. Patients will be seen in follow-up ever 3+/- 1 months for 1 year from completion of protocol therapy.

Conditions

• Pancreas Neoplasm Malignant Resectable

Interventions

Type	Name	Description
DRUG	Folfox6
DRUG	Gemcitabine
RADIATION	Radiation Therapy
PROCEDURE	Pancreaticoduodenectomy with retroperitoneal lymphadenectomy

Timeline

• Start date: 2014-02-01
• Primary completion: 2017-06-28
• Completion: 2020-01-14
• First posted: 2014-09-17
• Last updated: 2023-10-27
• Results posted: 2023-10-27

Locations

1 site across 1 country: United States