Neoadjuvant FDR GX in Locally Advanced Pancreatic Cancer
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|ClinicalTrials.gov Identifier: NCT01268384|
Recruitment Status : Completed
First Posted : December 30, 2010
Last Update Posted : December 6, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Cancer||Drug: Gemcitabine plus Capecitabine||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||43 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Fixed Dose Rate Gemcitabine Plus Capecitabine in Locally Advanced Pancreatic Cancer|
|Study Start Date :||April 2006|
|Actual Primary Completion Date :||July 2010|
|Actual Study Completion Date :||August 2011|
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
- R0 resection rate [ Time Frame: 6 months ]Microscopic complete resection rate after neoadjuvant chemotherapy
- Adverse events associated with neoadjuvant chemotherapy [ Time Frame: 6 months ]NCI CTCAE v.3.0 based AEs
- Overall survival [ Time Frame: 2 years ]Overall survival after enrollment
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01268384
|Korea, Republic of|
|Asan Medical Center|
|Seoul, Korea, Republic of, 138-736|
|Principal Investigator:||Jae-Lyun Lee, MD, PhD||Asan Medical Center|