Phase 2
Completed N=15
Study of Stereotactic Body Radiation Therapy in Patients With Intact Pancreatic Cancer
Source: ClinicalTrials.gov NCT01342354 ↗Enrolled (actual)
15
Serious AEs
26.7%
Results posted
Jul 2025
Primary outcomePrimary: Maximum Tolerated Dose (Phase 1) — 45 Gy
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Tolerated Dose (Phase 1) |
45 | — |
| SECONDARY The Number of Patients With Late (>28 Days) Grade 3+ GI Toxicity |
2; 0; 2 | — |
| SECONDARY Number of Participants With an Improvement in Patient Reported Pain Score Using Visual Analog Scale |
3; 0; 2 | — |
| SECONDARY Number of Patients Eligible for Surgery to Remove Tumor After Treatment |
0; 0; 0 | — |
| SECONDARY Number of Patients With Local Disease Control |
3; 3; 5 | — |
| SECONDARY Change From Baseline in Patient Reported Outcomes Using FACT-Hepatobiliary (FACT-Hep) Quality of Life Questionnaire. |
142; 157 | — |
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 = 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.
Data sourced from ClinicalTrials.gov (NCT01342354). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.