Clinical Trials Search
Clinical Trial 18941
Study Type: Treatment
Phase of Study: Phase II
- Mokenge Malafa
Preoperative Extended Chemotherapy vs. Chemotherapy Plus Hypofractionated Radiation Therapy for Borderline Resectable Adenocarcinoma of the Head of the Pancreas
The purpose of this study is to compare any good and bad effects of using chemotherapy compared to chemotherapy and radiation prior to surgery. This study will allow the researchers to know whether which approach is better, the same, or worse than the other.
2.1 Primary Objective: To evaluate and estimate 18 months overall survival (OS) rate of patients with borderline resectable PDAC receiving neoadjuvant therapy consisting of one of the following regimens prior to intended surgical resection and adjuvant therapy with 4 cycles of FOLFOX: 1) Arm 1: 8 cycles of systemic FOLFIRINOX, and/or; 2) Arm 2: 7 cycles of systemic FOLFIRINOX followed by hypofractionated radiation therapy. 2.2 Secondary Objectives: 2.2.1 To evaluate and estimate the R0 resection rates in patients receiving each of the two multimodality treatment regimens. 2.2.2 To evaluate and estimate the event-free survival in patients receiving each of the two multimodality treatment regimens. 2.2.3 To evaluate and estimate the pathologic compete response (pCR) rates in patients receiving each of the two multimodality treatment regimens. 2.2.4 To assess the adverse events (AE) profile and safety of each treatment arm. 2.3 Other Objective: Results of the primary analysis will be examined for consistency, while taking into account the stratification factors and/or covariates of baseline QOL and fatigue.