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Clinical Trial Record

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Pilot Study of Short-Course Preoperative Stereotactic Body Radiation Therapy for Resectable Pancreatic Cancer

2014-12

2022-04-13

2022-04-13

18

Study Overview

Pilot Study of Short-Course Preoperative Stereotactic Body Radiation Therapy for Resectable Pancreatic Cancer

The purpose of this study is to determine whether a short-course of stereotactic body radiotherapy (SBRT) prior to surgical resection of pancreatic adenocarcinoma is feasible and well-tolerated.

This will be a Phase 2, single center, prospective, single arm feasibility study of the use of stereotactic body radiotherapy (SBRT) for the preoperative treatment of surgically resectable pancreatic adenocarcinoma.

  • Pancreatic Cancer
  • Adenocarcinoma
  • RADIATION: Preoperative SBRT
  • UGIP14107

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates Results Reporting Dates Study Record Updates

2014-12-24  

N/A  

2022-07-15  

2015-01-21  

N/A  

2022-07-18  

2015-01-27  

N/A  

2022-07  

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/ArmIntervention/Treatment
EXPERIMENTAL: Preoperative SBRT

This will be a Phase 2, single center, prospective, single arm feasibility study of the use of stereotactic body radiotherapy (SBRT) for the preoperative treatment of surgically resectable pancreatic adenocarcinoma.

RADIATION: Preoperative SBRT

  • This will be a Phase 2, single center, prospective, single arm feasibility study of the use of stereotactic body radiotherapy (SBRT) for the preoperative treatment of surgically resectable pancreatic adenocarcinoma.
Primary Outcome MeasuresMeasure DescriptionTime Frame
Incidence of grade 2 or greater toxicityNumber of incidence of grade 2 or greater toxicity2 years
Secondary Outcome MeasuresMeasure DescriptionTime Frame
Number of Participants with no further growth of cancer at original site (Local control)Count subjects with no further growth of cancer at original site.2 years
Count subjects with Recurrence of cancer in other body sitesCompare recurrence locations of treated patients relative to historical controls.2 years
Time to Progression of pancreatic cancerDuration of progression free survival of treated patients4 years
Time to deathMeasure duration of survival of treated patients.4 years

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

    Inclusion Criteria:
    1. Patient with pathologically proven diagnosis of adenocarcinoma of the head of the pancreas 2. CT w/ contrast using the pancreas protocol or MRI of the abdomen with contrast within 6 weeks prior to registration 3. CT chest or PET/CT within 6 weeks prior to registration 4. Clinically determined to be resectable based on NCCN Criteria: 5. No radiographic evidence of superior mesenteric vein or portal vein distortion 6. No evidence of distant metastasis 7. Clear fat planes around the celiac axis, hepatic artery, and superior mesenteric artery 8. No enlarged lymph nodes per CT criteria or PET avid lymph nodes 9. No lymphadenopathy outside the surgical field (i.e. celiac or para-aortic adenopathy) 10. Adequate cardiopulmonary reserves to tolerate surgery 11. Karnofsky performance status > 70 12. Age >18 13. Adequate bone marrow function defined as follows: 14. Absolute neutrophil count (ANC) > 1800 cells/mm3 15. Platelets ≥ 100,000 cells/mm3 16. Hemoglobin > 8.0 g/dl (Note: The use of transfusion or other intervention to achieve Hgb > 8 g/dl is acceptable.) 17. Pregnancy test must be negative for women of childbearing potential within 7 days prior to study entry 18. Patient must sign study specific informed consent prior to study entry
    Exclusion Criteria:
    1. Prior surgical resection of any pancreatic malignancy 2. Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years 3. Any prior chemotherapy or radiation for treatment of the patient's pancreatic tumor. 4. Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields 5. Severe, active comorbidity, defined as follows:
    1. Unstable angina and/or congestive heart failure requiring hospitalization within the last 12 months 2. Transmural myocardial infarction within the last 6 months 3. Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration 4. Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days prior to registration. 6. Severe, uncorrectable hepatic insufficiency and/or coagulation defects due to liver failure 7. Any evidence of distant metastases (M1) 8. Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the treatment involved in this study may be significantly teratogenic

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

    • PRINCIPAL_INVESTIGATOR: Alan W Katz, MD MPH, University of Rochester

    Publications

    The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

    General Publications

    No publications available

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