Stereotactic Body Radiation Therapy and Capecitabine Before Surgery in Treating Patients With Pancreatic Cancer That Can be Removed by Surgery
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|ClinicalTrials.gov Identifier: NCT01918644|
Recruitment Status : Recruiting
First Posted : August 8, 2013
Last Update Posted : April 5, 2017
|Condition or disease||Intervention/treatment||Phase|
|Stage IA Pancreatic Cancer Stage IB Pancreatic Cancer Stage IIA Pancreatic Cancer Stage IIB Pancreatic Cancer||Radiation: stereotactic body radiation therapy Drug: capecitabine Procedure: therapeutic conventional surgery Procedure: magnetic resonance imaging Other: laboratory biomarker analysis||Phase 1|
I. To determine the recommended-phase-II-dose (RPTD) of stereotactic body radiation therapy (SBRT) at an escalating dose schedule when combined with standard-dose capecitabine as neoadjuvant therapy for resectable carcinoma of exocrine pancreas.
I. To estimate the incidence of overall 30-day post-operative complications. II. To estimate the radiological response rates. III. To estimate the pathological response rates. IV. To estimate the rates of resection with negative margins. V. To estimate the recurrence free survival (RFS). VI. To estimate the overall survival (OS).
TERTIARY OBJECTIVES (OPTIONAL):
I. To define tumor volume (TV), dynamic contrast enhancement (DCE) pattern and mean apparent diffusion coefficient (ADC) measurements in diffusion-weighted magnetic resonance (MR) imaging (DWI) in patients with resectable pancreatic cancer undergoing neoadjuvant SBRT and concomitant chemotherapy (ChT).
II. To correlate TV, DCE and ADC measurements at baseline magnetic resonance imaging (MRI) versus final pathological response.
III. To correlate TV, DCE and ADC changes from baseline in MRI done three weeks post-SBRT versus final pathological response.
IV. To predict surgical margin status using MRI done at baseline and at three weeks post-SBRT.
V. To correlate TV, DCE and ADC changes from baseline in MRI done post-3rd fraction at baseline versus final pathological response.
VI. To describe in the biopsy and/ or the surgical specimen, expression of following markers: secreted protein acidic and rich in cysteine (SPARC) expression; distribution of pancreatic stellate cells (PSC); distribution of cluster of differentiation (CD)4+/ CD8+ T cell, CD56+ natural killer (NK) cells; other molecular and inflammatory cellular markers may be explored.
VII. To describe changes induced by neoadjuvant therapy by comparison of expression of these markers between the biopsy and the surgical specimen.
VIII. To compare baseline and/ or post-treatment expression with treatment response, toxicity and clinical survival outcome.
OUTLINE: This is a dose-escalation study of SBRT.
Patients undergo SBRT every other day over 2 weeks for a total of 5 fractions and receive capecitabine orally (PO) every 12 hours 5 days a week for 2 weeks. Patients then undergo definitive surgery after a minimum of 2 weeks from the completion of SBRT.
After completion of study treatment, patients are followed up at 1 month and 3 months, every 3 months for 1 year, and then every 6 months for 2 years.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||36 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase Ia-Ib Dose-escalation Study Evaluating Safety and Efficacy of Neoadjuvant Stereotactic Body Radiotherapy (SBRT) With Concomitant Capecitabine Chemotherapy for Resectable Carcinoma of Exocrine Pancreas.|
|Study Start Date :||August 2013|
|Estimated Primary Completion Date :||July 2018|
|Estimated Study Completion Date :||December 2020|
Experimental: Treatment (SBRT, capecitabine, and surgery)
Patients undergo SBRT every other day over 2 weeks for a total of 5 fractions and receive capecitabine PO every 12 hours 5 days a week for 2 weeks. Patients then undergo definitive surgery after a minimum of 2 weeks from the completion of SBRT.
Radiation: stereotactic body radiation therapy
Other Names:Drug: capecitabine
Other Names:Procedure: therapeutic conventional surgery
Undergo definitive surgeryProcedure: magnetic resonance imaging
Optional correlative studies
Other Names:Other: laboratory biomarker analysis
Optional correlative studies
- Incidence of dose-limiting toxicity defined as any grade 3-4 non-hematologic toxicity or grade 5 toxicity attributable to combination chemo-radiotherapy per the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 [ Time Frame: Up to 90 days from the start of SBRT and capecitabine ]The number and percent of patients reporting adverse events (all, severe or worse, serious and related) will be quantified for each dose level.
- Incidence of 30-day post-operative complications [ Time Frame: 30 days ]Will be expressed as a percentage.
- Radiological response per Response Evaluation Criteria in Solid Tumors (RECIST) and volumetric measurements [ Time Frame: Up to 3 years ]Will be expressed as a percentage.
- Pathological response, graded based on the College of American Pathologists (CAP) and Ishikawa, Evans, and Chun grading systems [ Time Frame: Up to 3 years ]Will be expressed as a percentage.
- Incidence of margin-negative resection, defined as the absence of viable tumor cells at the inked surgical margin [ Time Frame: Up to 3 years ]Will be expressed as a percentage.
- Loco-regional recurrence free survival, defined with follow-up radiological assessment [ Time Frame: From the point of start of SBRT to the point of recurrence or death, assessed up to 3 years ]Kaplan-Meier estimates will be calculated. Log-rank test and Cox regression analysis will be used for univariate and multivariate analyses, respectively. Chi square and regression analysis will be performed to test association of categorical variables with treatment response.
- OS [ Time Frame: From the point of start of SBRT to the time of death or last follow-up if alive, assessed up to 3 years ]Kaplan-Meier estimates will be calculated. Log-rank test and Cox regression analysis will be used for univariate and multivariate analyses, respectively. Chi square and regression analysis will be performed to test association of categorical variables with treatment response.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01918644
|Contact: Cancer Connect||(800) email@example.com|
|United States, Wisconsin|
|University of Wisconsin Carbone Cancer Center||Recruiting|
|Madison, Wisconsin, United States, 53792|
|Contact: Cancer Connect 800-622-8922 firstname.lastname@example.org|
|Principal Investigator: Mark A. Ritter, MD, PhD|
|Principal Investigator: Michael Bassetti, MD, PhD|
|Principal Investigator:||Mark Ritter||University of Wisconsin, Madison|