Back to resultsStudy of Stereotactic Body Radiation Therapy in Patients With Intact Pancreatic Cancer
Primary Purpose
Pancreatic Cancer
Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Stereotactic Radiation
Sponsored by
About this trial
This is an interventional treatment trial for Pancreatic Cancer focused on measuring Pancreatic Cancer, Stereotactic Radiation
Eligibility 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.
Sites / Locations
- University of Chicago
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Stereotactic Radiation
Arm Description
Escalating doses of SBRT in three doses over ten days.
Outcomes
Primary Outcome Measures
Maximum Tolerated Dose (phase 1)
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
Secondary Outcome Measures
Reported side effects
Change in patient reported pain score using visual analog scale
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
Number of patients with disease control
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01342354
Brief Title
Study of Stereotactic Body Radiation Therapy in Patients With Intact Pancreatic Cancer
Official Title
A Study of Stereotactic Body Radiation Therapy in Patients With Unresected Carcinoma of the Pancreas or Ampulla
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
April 14, 2009 (Actual)
Primary Completion Date
August 2020 (Actual)
Study Completion Date
June 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
Keywords
Pancreatic Cancer, Stereotactic Radiation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
17 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Stereotactic Radiation
Arm Type
Experimental
Arm Description
Escalating doses of SBRT in three doses over ten days.
Intervention Type
Radiation
Intervention Name(s)
Stereotactic Radiation
Intervention Description
Escalating Doses of SBRT in periods of three doses over 10 days
Primary Outcome Measure Information:
Title
Maximum Tolerated Dose (phase 1)
Description
Side effects will be assessed after 28 days of treatment to determine tolerability of the dose of radiation.
Time Frame
28 days
Title
Identify the appropriate dose for treatment of unresected carcinoma of the ampulla or pancreas
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Reported side effects
Time Frame
12 months after treatment
Title
Change in patient reported pain score using visual analog scale
Description
Using the visual analog scale, patients rate pain from 1-10 with higher scores indicate greater pain intensity.
Time Frame
12 months after treatment
Title
Number of patients eligible for surgery to remove tumor after treatment
Time Frame
12 months after treatment
Title
Number of patients with disease control
Description
Number of patients with no disease progression as measured by tumor imaging
Time Frame
12 months after treatment
Title
Change in patient reported outcomes using FACT-Hepatobiliary (FACT-Hep) quality of life questionnaire.
Time Frame
12 months after treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stanley Liauw, MD
Organizational Affiliation
University of Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study of Stereotactic Body Radiation Therapy in Patients With Intact Pancreatic Cancer
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