Neoadjuvant FDR GX in Locally Advanced Pancreatic Cancer
The rationale for phase II trial of neoadjuvant fixed dose rate gemcitabine plus capecitabine for patients with LAPC includes the following: First, obtaining a sufficient tumor down-staging to procure R0/R1 resection, reported to be one of the most significant prognostic factors for survival; second, providing an observation period to exclude from surgery those patients with rapidly progressive disease there by to help select patients for surgery who have the greatest likelihood of a favorable postoperative outcome; third, eliminating micrometastatic disease, that is likely present in most patients, earlier than adjuvant setting and preventing post-surgical growth spurts; fourth, adjuvant therapy given in the neoadjuvant setting is better tolerated, as the patient has not recently undergone a major operation; and the last, the lack of widely accepted optimal preoperative or palliative approach in patients with LAPC, the majority of whom may not be operated on.
The primary goal is to determine the R0 resection rate of the neoadjuvant fixed dose rate (FDR) gemcitabine-capecitabine combination chemotherapy in patients with borderline resectable or unresectable locally advanced pancreatic adenocarcinoma.
The secondary goals are to assess progression-free survival (PFS) and OS (overall survival) in these patients and to assess adverse events of these neoadjuvant treatments.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of Fixed Dose Rate Gemcitabine Plus Capecitabine in Locally Advanced Pancreatic Cancer|
- R0 resection rate [ Time Frame: 6 months ] [ Designated as safety issue: No ]Microscopic complete resection rate after neoadjuvant chemotherapy
- Adverse events associated with neoadjuvant chemotherapy [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]NCI CTCAE v.3.0 based AEs
- Overall survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]Overall survival after enrollment
|Study Start Date:||April 2006|
|Study Completion Date:||August 2011|
|Primary Completion Date:||July 2010 (Final data collection date for primary outcome measure)|
Fixed dose rate gemcitabine plus capecitabine every 3 weeks for 3-9 cycles
Drug: Gemcitabine plus Capecitabine
Gemcitabine 1,250 mg/m2 mixed with 0.9% saline 500 ml i.v. for 10 mg/m2/min on D1 and D8 Capecitabine 950 mg/m2 b.i.d. po from D1 to D14 every 21 days
Please refer to this study by its ClinicalTrials.gov identifier: NCT01268384
|Korea, Republic of|
|Asan Medical Center|
|Seoul, Korea, Republic of, 138-736|
|Principal Investigator:||Jae-Lyun Lee, MD, PhD||Asan Medical Center|