A Phase I Study of Stereotactic Body Radiation Therapy in Patients With Unresected Carcinoma of the Pancreas or Ampulla
- Patients must have histologically confirmed, unresected cancer of the pancreas or
ampulla. The cancer may include any invasive histology (e.g. adenocarcinoma,
- 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
- 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
- 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.
- 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
- Use of bevacizumab or vascular endothelial growth factor inhibitor chemotherapy
within 3 months before RT or 6 months after RT.