NCT03322995

Pancreatic Cancer Adaptive Neoadjuvant Chemotherapy Trial

Adaptive Modification of Neoadjuvant Therapy Based on Clinical Response in Patients With Localized Pancreatic Cancer

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 125 (estimated)
• Sponsor: Medical College of Wisconsin · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, phase II study in patients with resectable and borderline resectable pancreas cancer.

Detailed description

Patients will receive standard chemotherapy and chemoradiation for pancreatic cancer. The study intervention is an adaptive approach which modifies systemic therapy based on clinical assessments of treatment response. Treatment response will be assessed by imaging (CT scan), biomarker \[serum cancer antigen (CA)19-9\] and performance status assessment \[short physical performance battery (SPPB) and Center for Epidemiologic Studies Depression Scale (CES-D) evaluations\] at the first restaging assessment. Treatment response will be categorized as: 1. response; 2. stable disease; 3. local disease progression; 4. metastatic disease progression. After the first restaging evaluation, patients who demonstrate: 1. a response will be maintained on the same chemotherapy; 2. stable disease will be changed to a defined alternative chemotherapy or molecular profile-directed therapy; 3. local progression will receive chemoradiation; 4. metastatic disease will be removed from the trial. Patients who complete four months of chemotherapy, will be treated with chemoradiation (50.4 Gray (Gy) in 28 fractions). In the absence of local disease progression deemed inoperable, or metastatic disease progression, patients will be offered surgical resection. Patients who did not receive four months of systemic therapy in the neoadjuvant setting will be offered four months of adjuvant therapy at the discretion of their treating physicians.

Conditions

• Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	First-line Chemotherapy	The first-line therapy will be 5-fluorouracil, leucovorin, irinotecan, and oxaliplatin (FOLFIRINOX) or best available standard of care.
DRUG	Second-line Chemotherapy	Second line therapies will be multi-agent and contain gemcitabine. Molecular profiling data from the initial endoscopic ultrasound (EUS)/ fine needle aspirate (FNA) biopsy may be used at the discretion of the treating physician.
RADIATION	Chemoradiation	50.4 Gy in 28 fractions.

Timeline

• Start date: 2018-06-21
• Primary completion: 2027-06-01
• Completion: 2032-06-01
• First posted: 2017-10-26
• Last updated: 2026-01-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study