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Radiotherapy With Chemotherapy as Neoadjuvant Therapy of Resectable and Borderline Resectable Pancreas Cancer

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ClinicalTrials.gov Identifier: NCT01333332
Recruitment Status : Unknown
Verified April 2011 by University of Virginia.
Recruitment status was:  Recruiting
First Posted : April 11, 2011
Last Update Posted : April 11, 2011
Information provided by:
University of Virginia

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Drug: Capecitabine Radiation: Standard Dose Acclerated Fraction Radiotherapy Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial of Accelerated Fraction Radiotherapy With Concomitant Capecitabine as Neoadjuvant Therapy of Resectable and Borderline Resectable Pancreas Cancer
Study Start Date : August 2010
Estimated Primary Completion Date : August 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Capecitabine, Radiation Drug: Capecitabine
Radiation: Standard Dose Acclerated Fraction Radiotherapy
Standard dose accelerated fraction radiotherapy

Primary Outcome Measures :
  1. To determine the safety of neoadjuvant accelerated fraction standard dose radiotherapy to 50 Gy with concomitant capecitabine in patients with resectable and borderline resectable pancreas cancer. [ Time Frame: 2 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  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.


  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.

Information from the National Library of Medicine

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): NCT01333332

Contact: Hanna K. Sanoff, MD 434-243-6454 hsanoff@Virginia.EDU

United States, Virginia
University of Virginia Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Erin Yarde, MS    434-243-8588    ery7b@virginia.edu   
Principal Investigator: Hanna K. Sanoff, MD         
Sponsors and Collaborators
University of Virginia

Responsible Party: Hanna K. Sanoff, MD, Assistant Professor, Principal Investigator, University of Virginia, Department of Medicine, Hematology and Oncology
ClinicalTrials.gov Identifier: NCT01333332     History of Changes
Other Study ID Numbers: 15050
First Posted: April 11, 2011    Key Record Dates
Last Update Posted: April 11, 2011
Last Verified: April 2011

Keywords provided by University of Virginia:

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Gastrointestinal Agents