Stereotactic Body Radiotherapy for Unresectable Pancreatic Cancer
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ClinicalTrials.gov Identifier: NCT01346410 |
Recruitment Status :
Completed
First Posted : May 3, 2011
Results First Posted : February 22, 2018
Last Update Posted : February 19, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Pancreatic Cancer | Radiation: Stereotactic Body Radiotherapy | Not Applicable |
This is a single institution, non-randomized, prospective, phase IV trial of SBRT for unresectable pancreatic cancer.
Data collected will include patient demographics, pathology data, tumor stage, SBRT dose fractionation scheme, dose received by adjacent critical normal tissues, tumor recurrence data, and acute and late toxicities.
Follow up data will be collected during the patient's standard office visits. The anticipated duration of this study is 5 years.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 1 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Phase IV Trial Evaluating the Use of Stereotactic Body Radiotherapy (SBRT) for the Treatment of Unresectable Pancreatic Cancer |
Study Start Date : | September 2008 |
Actual Primary Completion Date : | July 2012 |
Actual Study Completion Date : | July 2012 |

Arm | Intervention/treatment |
---|---|
Experimental: A
Stereotactic Radiation to Pancreas
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Radiation: Stereotactic Body Radiotherapy
Suggested fractionation is 20-25 Gy / 1 fraction OR 30-36 Gy / 3 fractions (10-12 Gy per fraction) OR 40-45 Gy / 5 fractions (8-9 Gy per fraction) |
- Local Control Rate [ Time Frame: 5 years ]Local recurrence is defined as tumor recurrence within the planning target volume. Local control rate will be evaluated by imaging techniques such as CT or MRI. Local recurrence will be defined as an increase of > 20% in tumor size. If necessary, a Positron Emission Tomography scan may be used to aid in diagnoses of local tumor recurrence.
- Late Toxicity Rate [ Time Frame: 5 years ]Toxicities will be graded using CTCAE criteria at specified timepoints.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patient age >= 18 years
- Performance status of 0-3
- Unresectable pancreatic cancer
- Maximum tumor diameter < 7.5 cm
- Signed study-specific consent form
Exclusion Criteria:
- Maximum tumor diameter > 7.5 cm
- Prior radiotherapy to the upper abdomen
- Pregnant or lactating women, due to potential exposure of the fetus to RT and unknown effects of RT on lactating females
- Patients with psychiatric or addictive disorder that would preclude obtaining informed consent

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): NCT01346410
United States, Missouri | |
St. John's Mercy Medical Center | |
Saint Louis, Missouri, United States, 63141 |
Responsible Party: | Kathy Baglan, MD, Radiation Oncologist, Mercy Research |
ClinicalTrials.gov Identifier: | NCT01346410 |
Other Study ID Numbers: |
08-060 |
First Posted: | May 3, 2011 Key Record Dates |
Results First Posted: | February 22, 2018 |
Last Update Posted: | February 19, 2020 |
Last Verified: | February 2020 |
pancreatic cancer |
Pancreatic Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms |
Endocrine Gland Neoplasms Digestive System Diseases Pancreatic Diseases Endocrine System Diseases |