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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01342354
Recruitment Status : Active, not recruiting
First Posted : April 27, 2011
Last Update Posted : April 1, 2021
Sponsor:
Information provided by (Responsible Party):
University of Chicago

Tracking Information
First Submitted Date  ICMJE April 15, 2011
First Posted Date  ICMJE April 27, 2011
Last Update Posted Date April 1, 2021
Actual Study Start Date  ICMJE April 14, 2009
Actual Primary Completion Date August 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 26, 2021)
  • Maximum Tolerated Dose (phase 1) [ Time Frame: 28 days ]
    Side effects will be assessed after 28 days of treatment to determine tolerability of the dose of radiation.
  • Identify the appropriate dose for treatment of unresected carcinoma of the ampulla or pancreas [ Time Frame: 28 days ]
Original Primary Outcome Measures  ICMJE
 (submitted: April 25, 2011)
Maximum Tolerated Dose [ Time Frame: 28 days ]
Side effects will be assessed after 28 days of treatment to determine tolerability of the dose of radiation.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 26, 2021)
  • Reported side effects [ Time Frame: 12 months after treatment ]
  • Change in patient reported pain score using visual analog scale [ Time Frame: 12 months after treatment ]
    Using the visual analog scale, patients rate pain from 1-10 with higher scores indicate greater pain intensity.
  • Number of patients eligible for surgery to remove tumor after treatment [ Time Frame: 12 months after treatment ]
  • Number of patients with disease control [ Time Frame: 12 months after treatment ]
    Number of patients with no disease progression as measured by tumor imaging
  • Change in patient reported outcomes using FACT-Hepatobiliary (FACT-Hep) quality of life questionnaire. [ Time Frame: 12 months after treatment ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Stereotactic Body Radiation Therapy in Patients With Intact Pancreatic Cancer
Official Title  ICMJE A Study of Stereotactic Body Radiation Therapy in Patients With Unresected Carcinoma of the Pancreas or Ampulla
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Pancreatic Cancer
Intervention  ICMJE Radiation: Stereotactic Radiation
Escalating Doses of SBRT in periods of three doses over 10 days
Study Arms  ICMJE Experimental: Stereotactic Radiation
Escalating doses of SBRT in three doses over ten days.
Intervention: Radiation: Stereotactic Radiation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: February 6, 2018)
17
Original Estimated Enrollment  ICMJE
 (submitted: April 25, 2011)
24
Estimated Study Completion Date  ICMJE June 1, 2022
Actual Primary Completion Date August 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01342354
Other Study ID Numbers  ICMJE 16866B
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Chicago
Study Sponsor  ICMJE University of Chicago
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Stanley Liauw, MD University of Chicago
PRS Account University of Chicago
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP