Neoadjuvant Folfirinox Followed by Capecitabine and Limited Field Radiation for Localized Pancreatic Head Adenocarcinoma
|ClinicalTrials.gov Identifier: NCT01677988|
Recruitment Status : Terminated (Study was terminated due to low accrual.)
First Posted : September 3, 2012
Results First Posted : January 15, 2016
Last Update Posted : January 15, 2016
|Condition or disease||Intervention/treatment||Phase|
|Adenocarcinoma of Head of Pancreas||Drug: Neo-adjuvant Chemotherapy Radiation: Chemoradiation Procedure: Surgical Resection||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Neoadjuvant Folfirinox Chemotherapy Followed by Capecitabine With Concurrent Limited Field Radiation Therapy in Patients With Localized Pancreatic Head Adenocarcinoma|
|Study Start Date :||July 2012|
|Actual Primary Completion Date :||October 2015|
Experimental: Chemotherapy, Chemoradiation, Surgery
Neoadjuvant Chemotherapy- Modified FOLFIRINOX chemotherapy Day 1 and Day 15 of 28 day cycles for 3 cycles with growth factor support Chemoradiation Surgical Resection
Drug: Neo-adjuvant Chemotherapy
Other Name: FOLFIRINOX chemotherapyRadiation: Chemoradiation
Procedure: Surgical Resection
- Estimate the R0/R1 Resection Rate [ Time Frame: at time of surgery ]Estimate the R0/R1 resection rate as the proportion of patients with R0 or R1 resection status based on the ITT population. R0 resection status is macroscopic complete removal of tumor by non-contaminated operation, with neither macroscopic nor microscopic residual tumor. R1 resection status is macroscopic complete removal of tumor by non-contaminated operation, with microscopic residual tumor.
- Radiographic Tumor Response [ Time Frame: From enrollment to Surgery ]The rate of CR, PR, SD and PD will be estimated as described in Section 14B prior to chemoradiation start and prior to surgery. The analysis population for estimation of radiographic response rate will be the ITT population.
- Histopathologic Tumor Response [ Time Frame: at the time of surgery ]Estimate the rate of good histopathologic response as the proportion of grade I and II responders. The analysis population for this objective is the ITT population. Any patient for whom a surgical sample is not available will be considered a poor-responder.
- Time to Recurrence: [ Time Frame: 2 years ]Time to recurrence is defined as the time from surgical resection to disease recurrence or death from any cause. Patients who have not recurred at the end of follow up will have their recurrence time censored at the last date of contact.
- Overall Survival: [ Time Frame: 2 years ]Overall survival is defined as the time from enrollment to death from any cause. Patients still alive at the end of follow up will have their survival time censored at the last date of contact.
- Feasibility Objective [ Time Frame: From enrollment to end of chemotherapy part of the study ]The feasibility of treating patients with localized pancreatic head adenocarcinoma with this neoadjuvant regimen will be evaluated by estimating the proportion of patients completing five of six planned doses. The analysis population will be the ITT population.
- CTC Analysis [ Time Frame: End of study ]To evaluate and describe CTC numbers, CTC phenotype characteristics and effectiveness/rate of CTC culturing techniques from patients with pancreatic adenocarcinoma.
- CTC Expression [ Time Frame: 2 years ]To determine and evaluate the correlation between expression or biomarkers in the CTCs and expression of biomarkers in resected tissue specimens within the same cancer patient.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01677988
|United States, South Carolina|
|Medical University of South Carolina|
|Charleston, South Carolina, United States, 29425|
|Principal Investigator:||Paul E. O'Brien, MD||Medical University of South Carolina|