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

NCT ID: NCT01342354

Last Updated: 2025-07-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-04-14
• Study Completion Date: 2022-06-01

Brief 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.

Conditions

Pancreatic Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Stereotactic Radiation: 10 Gy x3

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

Group Type: EXPERIMENTAL

Stereotactic Radiation 10 Gy

Intervention Type: RADIATION

10 Gy three times over 10 days

Stereotactic Radiation: 12.5 Gy x3

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

Group Type: EXPERIMENTAL

Stereotactic Radiation 12.5 Gy

Intervention Type: RADIATION

12.5 Gy three times over 10 days

Stereotactic Radiation: 15 Gy x3

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

Group Type: EXPERIMENTAL

Stereotactic Radiation 15 Gy

Intervention Type: RADIATION

15 Gy three times over 10 days

Interventions

Stereotactic Radiation 10 Gy

10 Gy three times over 10 days

Intervention Type: RADIATION

Stereotactic Radiation 12.5 Gy

12.5 Gy three times over 10 days

Intervention Type: RADIATION

Stereotactic Radiation 15 Gy

15 Gy three times over 10 days

Intervention Type: RADIATION

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 = 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Chicago

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stanley Liauw, MD

Role: PRINCIPAL_INVESTIGATOR

University of Chicago

Locations

University of Chicago

Chicago, Illinois, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

16866B

Identifier Type: -

Identifier Source: org_study_id