Clinical trialPhase 1 / Phase 2Completed
Study of Stereotactic Body Radiation Therapy in Patients With Intact Pancreatic Cancer
A Study of Stereotactic Body Radiation Therapy in Patients With Unresected Carcinoma of the Pancreas or Ampulla
- Outcome
- Outcome unknown
- Phase
- Phase 1 / Phase 2
- Status
- Completed
- Study type
- Interventional
- Start
- 14 April 2009
- Expected end
- 1 June 2022
- Enrollment
- 15 participants
- Sites
- 1
- Primary outcomes
- Maximum Tolerated Dose (Phase 1)
- Sponsor
- Other
- Results posted
- 2025-07-18
- Last update
- 18 July 2025
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Brief summary public domain (ClinicalTrials.gov)
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.
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Maximum Tolerated Dose (Phase 1) [28 days]. Number, Gy. Stereotactic Radiation (n=15): 45.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
The Number of Patients With Late (>28 Days) Grade 3+ GI Toxicity [12 months after treatment]. Number, participants. Stereotactic Radiation: 10 Gy x3 (n=3): 2; Stereotactic Radiation: 12.5 Gy x3 (n=3): 0; Stereotactic Radiation: 15 Gy x3 (n=9): 2.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Number of Participants With an Improvement in Patient Reported Pain Score Using Visual Analog Scale [12 months after treatment]. Count Of Participants, Participants. Stereotactic Radiation: 10 Gy x3 (n=3): 3; Stereotactic Radiation: 12.5 Gy x3 (n=0): 0; Stereotactic Radiation: 15 Gy x3 (n=5): 2.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Number of Patients Eligible for Surgery to Remove Tumor After Treatment [12 months after treatment]. Number, participants. Stereotactic Radiation: 10 Gy x3 (n=3): 0; Stereotactic Radiation: 12.5 Gy x3 (n=3): 0; Stereotactic Radiation: 15 Gy x3 (n=9): 0.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Number of Patients With Local Disease Control [12 months after treatment]. Number, participants. Stereotactic Radiation: 10 Gy x3 (n=3): 3; Stereotactic Radiation: 12.5 Gy x3 (n=3): 3; Stereotactic Radiation: 15 Gy x3 (n=9): 5.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Change From Baseline in Patient Reported Outcomes Using FACT-Hepatobiliary (FACT-Hep) Quality of Life Questionnaire. [12 months after treatment]. Mean, score on a scale (Standard Deviation). Baseline: Stereotactic Radiation: 15 Gy x3 (n=5): 142 (24). 12 months: Stereotactic Radiation: 15 Gy x3 (n=5): 157 (0).