Pancreatic Cancer Adaptive Neoadjuvant Chemotherapy Trial
- Conditions
- Pancreatic Cancer
- Interventions
- Drug: First-line ChemotherapyDrug: Second-line ChemotherapyRadiation: Chemoradiation
- Registration Number
- NCT03322995
- Lead Sponsor
- Medical College of Wisconsin
- Brief 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 125
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Restaging: Response to Treatment First-line Chemotherapy After the first restaging evaluation, further treatment will be based on treatment response. Patients who demonstrate a response \[decline in carbohydrate antigen 19-9 (CA19-9) values\] and radiographic response, along with preserved performance status) will be maintained on the first line chemotherapy for an additional two months. Restaging: Patients with Stable Disease Second-line Chemotherapy Patients who do not have a significant decline in CA19-9 values will be changed to a second-line therapy for an additional two months. Restaging: Local Disease Progression Chemoradiation After the first restaging evaluation, further treatment will be based on treatment response. If, at the initial restaging, the patient has local disease progression amenable to surgical resection, he or she will receive chemoradiation, rather than continued chemotherapy, so the window of opportunity for surgical resection is not lost.
- Primary Outcome Measures
Name Time Method Completion of all intended neoadjuvant therapy and surgical therapy Five years. This measure is the number of subjects completing all intended neoadjuvant therapy and surgical therapy.
- Secondary Outcome Measures
Name Time Method Overall survival Five years This measure is the number of subjects alive at the conclusion of the follow-up period.
Progression-free survival Five years This measure is the number of subjects achieving complete response, partial response or maintaining stable disease.
Trial Locations
- Locations (1)
Froedtert & the Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States