View Clinical Trial (Medical Research Study)
Phase II Trial of Accelerated Fraction Radiotherapy With Concomitant Capecitabine as Neoadjuvant Therapy of Resectable and Borderline Resectable Pancreas Cancer
| City: |
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Charlottesville |
| State: |
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Virginia |
| Zip Code: |
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22908 |
| Conditions: |
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Pancreatic Cancer |
| Purpose: |
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The purpose of this study is to determine safety and to obtain preliminary estimates of the
rate of major pathologic response of neoadjuvant accelerated fraction, standard dose
radiation given with chemotherapy in patients with locally advanced pancreas cancer.
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| Study Summary: |
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| Criteria: |
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Inclusion:
1. Clinically staged I-III, pathologically confirmed adenocarcinoma of the pancreas.
Mixed (e.g. adeno-squamous, neuroendocrine features) and/or poorly differentiated
carcinomas are eligible as long as the carcinoma is not a predominantly
neuroendocrine carcinoma. Cancers must be deemed by multidisciplinary assessment at
UVA to be either
- Resectable
- No overt evidence of vascular involvement
- No overt metastatic disease
- Borderline Resectable, meeting one of the following categories:
- Local tumor characteristics:
- Abutment of <180◦ of the superior mesenteric artery and/or celiac
axis
- Abutment or encasement of a short segment hepatic artery
- Involvement of the portal vein or superior mesenteric vein amenable to
vascular reconstruction
- Concern for extra pancreatic metastatic disease
- indeterminant nodule on imaging
- Pathologically confirmed N1
- Borderline performance status or medical comorbidities as determined by
investigators to be concerning for patient's ability to tolerate pancreatic
resection
- Patients with overtly unresectable disease are ineligible
2. No prior therapy for pancreatic cancer, including surgery, radiation, or chemotherapy
3. ≥18 years of age
4. Able to provide informed consent and comply with study procedures
5. Concurrent therapy with warfarin is permitted, but INR must be checked weekly
6. Concurrent therapy with phenytoin is permitted, but phenytoin levels must be checked
weekly.
7. Concurrent therapy with CYP2C9 substrates is permitted but discouraged. Patients
taking fluoxetine, glipizide, losartan, voriconazole, or other CYP2C9 substrates
should consider switching to an alternative medication if feasible. (see Appendix
11.3 for a list of CYP2C9 substrates).
8. Adequate organ function:
- Hematologic
- ANC ≥ 1.5 x 10^9 cells/liter
- Plts ≥ 100,000 x 10^9 cells/liter
- Hepatic
- Total bilirubin ≤ 5 fold the upper limits of normal for laboratory if due
to biliary obstruction secondary to disease. For patients with total
bilirubin 3-5 times the upper limit, attempt to relieve biliary obstruction
is required
- AST/ALT ≤ 5 fold the upper limits of normal for laboratory
- Renal
- Creatinine clearance as measured by Cockcroft-Gault (APPENDIX) of >30
mL/min.
- Patients with creatinine clearance of 30-50 mL/min require 25% reduction of
capecitabine dose.
Exclusion:
1. No pregnant or lactating women. Women of child bearing age must have a negative
pregnancy test within seven days of beginning therapy and agree to use reliable
contraception for the duration of the study period.
2. No comorbid condition which is deemed by the investigator to have a life expectancy
of less than 6 months
3. No other malignancy diagnosed within the past 5 years, excepting all in situ cancers
and invasive nonmelanomatous skin cancers.
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| NCT ID: |
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NCT01333332 |
| Primary Contact: |
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Hanna K. Sanoff, MD
Phone: 434-243-6454
Email: hsanoff@Virginia.EDU
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| Backup Contact: |
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N/A |
| Location Contact: |
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Charlottesville, Virginia 22908
United States
Erin Yarde, MS
Phone: 434-243-8588
Email: ery7b@virginia.edu
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 22, 2013 |
| Modifications to this listing: |
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