NCT04130399

Study of Neoadjuvent Chemotherapy Followed by SBRT in Patients With Resectable and Borderline Resectable Pancreatic Cancer

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Indiana University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to research the effects of delivering full-dose neoadjuvant multi-agent chemotherapy (folfirinox) followed by stereotactic body radiation therapy (SBRT) in patients with resectable pancreatic ductal adenocarcinoma (PDAC) in order to intensify local therapy and improve outcomes.

Detailed description

Primary Objectives: 1\. To assess one-year local control rates in patients with operable PDAC who receive neoadjuvant chemotherapy and SBRT Secondary Objectives: 1. To assess the following disease control endpoints: pathological response, disease-free survival, overall survival, failure pattern (local vs. distant) and time to development of distant metastases 2. To assess safety of the SBRT regimen Exploratory objectives 1. To obtain exploratory data correlating tumor response grade with changes in circulating tumor DNA levels following chemotherapy, SBRT, and surgery in patients with PDAC 2. To obtain exploratory data correlating circulating tumor DNA (ctDNA) changes with disease control endpoints (overall survival, disease-free survival, failure pattern, and time to development of distant metastases) 3. To obtain exploratory data on positron emission tomography (PET) and magnetic resonance imaging (MRI) findings and correlations with tumor response among patients treated on study.

Conditions

• Pancreatic Cancer
• Pancreatic Adenocarcinoma

Interventions

Type	Name	Description
RADIATION	Stereotactic Body Radiation Therapy (SBRT)	Patients will receive 5 fractions of SBRT delivered over a five-day period. Treatment may be delivered over 2 weeks, provided that the patient receives at least 2 fractions per week.
DRUG	FOLFIRINOX	Participants in this trial will receive neoadjuvant and adjuvant FOLFIRINOX chemotherapy for 6 cycles (1 cycle = 14 days) per routine guidelines

Timeline

• Start date: 2019-07-01
• Primary completion: 2022-01-01
• Completion: 2023-01-01
• First posted: 2019-10-17
• Last updated: 2019-10-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study