Study of Stereotactic Body Radiation Therapy in Patients With Intact Pancreatic Cancer

The University of Chicago

Status and phase: Completed; Phase 2; Phase 1

Conditions: Pancreatic Cancer

Treatments: Radiation: Stereotactic Radiation 15 Gy; Radiation: Stereotactic Radiation 10 Gy; Radiation: Stereotactic Radiation 12.5 Gy

Study type: Interventional

Funder types: Other

Identifiers

NCT01342354

16866B

Details and patient eligibility

About

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.

Enrollment: 15 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 = 2 (Karnofsky > 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

---

15 participants in 3 patient groups

Stereotactic Radiation: 10 Gy x3

Experimental group

Description:

Level 1 - SBRT 10Gy in three doses over ten days (total 30 Gy).

Treatment:

Radiation: Stereotactic Radiation 10 Gy

Stereotactic Radiation: 12.5 Gy x3

Experimental group

Description:

Level 2 - SBRT 12.5Gy in three doses over ten days (total 37.5 Gy).

Treatment:

Radiation: Stereotactic Radiation 12.5 Gy

Stereotactic Radiation: 15 Gy x3

Experimental group

Description:

Level 3 - SBRT 15Gy in three doses over ten days (total 45 Gy).

Treatment:

Radiation: Stereotactic Radiation 15 Gy