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

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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

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.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Radiation: Stereotactic Radiation Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Study of Stereotactic Body Radiation Therapy in Patients With Unresected Carcinoma of the Pancreas or Ampulla
Actual Study Start Date : April 14, 2009
Actual Primary Completion Date : August 2020
Estimated Study Completion Date : June 1, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.

  2. Identify the appropriate dose for treatment of unresected carcinoma of the ampulla or pancreas [ Time Frame: 28 days ]

Secondary Outcome Measures :
  1. Reported side effects [ Time Frame: 12 months after treatment ]
  2. 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.

  3. Number of patients eligible for surgery to remove tumor after treatment [ Time Frame: 12 months after treatment ]
  4. Number of patients with disease control [ Time Frame: 12 months after treatment ]
    Number of patients with no disease progression as measured by tumor imaging

  5. Change in patient reported outcomes using FACT-Hepatobiliary (FACT-Hep) quality of life questionnaire. [ Time Frame: 12 months after treatment ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

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): NCT01342354


Locations
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United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
Investigators
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Principal Investigator: Stanley Liauw, MD University of Chicago
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Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT01342354    
Other Study ID Numbers: 16866B
First Posted: April 27, 2011    Key Record Dates
Last Update Posted: April 1, 2021
Last Verified: March 2021
Keywords provided by University of Chicago:
Pancreatic Cancer
Stereotactic Radiation
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases