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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by University of Virginia.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Virginia
ClinicalTrials.gov Identifier:
NCT01333332
First received: March 4, 2011
Last updated: April 8, 2011
Last verified: April 2011
  Purpose

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 Intervention Phase
Pancreatic Cancer
Drug: Capecitabine
Radiation: Standard Dose Acclerated Fraction Radiotherapy
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University of Virginia:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 35
Study Start Date: August 2010
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Capecitabine, Radiation Drug: Capecitabine
Capecitabine
Radiation: Standard Dose Acclerated Fraction Radiotherapy
Standard dose accelerated fraction radiotherapy

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01333332

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

Locations
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
  More Information

No publications provided

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
Study First Received: March 4, 2011
Last Updated: April 8, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Virginia:
Pancreas
Radiation

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Pancrelipase
Capecitabine
Fluorouracil
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 23, 2014