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Study of Stereotactic Body Radiation Therapy in Patients With Intact Pancreatic Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by University of Chicago
Sponsor:
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT01342354
First received: April 15, 2011
Last updated: October 14, 2014
Last verified: October 2014
  Purpose

This purpose of this study is to determine the highest tolerated dose of Stereotactic Body Radiation Therapy (SBRT) and also to determine the appropriate dose for intact pancreatic cancer.


Condition Intervention Phase
Pancreatic Cancer
Radiation: Stereotactic Radiation
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Study of Stereotactic Body Radiation Therapy in Patients With Unresected Carcinoma of the Pancreas or Ampulla

Resource links provided by NLM:


Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • Maximum Tolerated Dose [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
    Side effects will be assessed after 28 days of treatment to determine tolerability of the dose of radiation.


Estimated Enrollment: 24
Study Start Date: April 2009
Estimated Study Completion Date: April 2017
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Stereotactic Radiation
Escalating doses of SBRT in three doses over ten days.
Radiation: Stereotactic Radiation
Escalating Doses of SBRT in periods of three doses over 10 days

  Eligibility

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

Inclusion Criteria:

  • Patients must have histologically confirmed, unresected cancer of the pancreas or ampulla. The cancer may include any invasive histology (e.g. adenocarcinoma, neuroendocrine carcinoma).
  • Patients must have measurable radiographic disease.Patients with previous complete resection are only eligible if there is measurable radiographic disease which is clearly felt to represent locally recurrent disease.
  • Patients may receive any number of cycles of chemotherapy prior to treatment with SBRT, but not within 2 weeks of the first fraction of RT.
  • Age > or = 18 years.
  • Eastern Cooperative Oncology Group (ECOG) performance status < or = 2 (Karnofsky > or = 60%)
  • Life expectancy of greater than 3 months.
  • Patients must have normal organ and marrow function.
  • Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

  • Concurrent investigational therapy delivered over the period of treatment or observation (28 days post-RT) for dose limiting toxicity.
  • Prior radiation therapy to the abdominal area which would overlap with the proposed area of treatment.
  • Pregnancy.
  • Primary disease > 7.5 cm in largest diameter as measured by CT or MRI.
  • Gross extension of tumor into the lumen of the duodenum.
  • Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  • Use of bevacizumab or vascular endothelial growth factor inhibitor chemotherapy within 3 months before RT or 6 months after RT.
  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: NCT01342354

Locations
United States, Illinois
University of Chicago Recruiting
Chicago, Illinois, United States, 60637
Contact: Kimberly Janko, RN, BSN    773-702-2856    kjanko@radonc.uchicago.edu   
Sponsors and Collaborators
University of Chicago
Investigators
Principal Investigator: Stanley Liauw, MD University of Chicago
  More Information

No publications provided

Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT01342354     History of Changes
Other Study ID Numbers: 16866B
Study First Received: April 15, 2011
Last Updated: October 14, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Chicago:
Pancreatic Cancer
Stereotactic Radiation

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Neoplasms
Neoplasms by Site
Pancreatic Diseases

ClinicalTrials.gov processed this record on November 19, 2014