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

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.

Study Overview

• Status: Completed
• Conditions: Pancreatic Cancer
• Intervention / Treatment: Radiation: Stereotactic Radiation 10 Gy; Radiation: Stereotactic Radiation 12.5 Gy; Radiation: Stereotactic Radiation 15 Gy

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Stereotactic Radiation: 10 Gy x3; Level 1 - SBRT 10Gy in three doses over ten days (total 30 Gy).	Radiation: Stereotactic Radiation 10 Gy; 10 Gy three times over 10 days
Experimental: Stereotactic Radiation: 12.5 Gy x3; Level 2 - SBRT 12.5Gy in three doses over ten days (total 37.5 Gy).	Radiation: Stereotactic Radiation 12.5 Gy; 12.5 Gy three times over 10 days
Experimental: Stereotactic Radiation: 15 Gy x3; Level 3 - SBRT 15Gy in three doses over ten days (total 45 Gy).	Radiation: Stereotactic Radiation 15 Gy; 15 Gy three times over 10 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum Tolerated Dose (Phase 1)	Side effects will be assessed after 28 days of treatment to determine tolerability of the dose of radiation.	28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Number of Patients With Late (>28 Days) Grade 3+ GI Toxicity	Grade 3+ GI late toxicity	12 months after treatment
Number of Participants With an Improvement in Patient Reported Pain Score Using Visual Analog Scale	Using the visual analog scale, patients rate pain from 1-10 with higher scores indicate greater pain intensity. Improvement in pain is defined as a yes/no response.	12 months after treatment
Number of Patients Eligible for Surgery to Remove Tumor After Treatment		12 months after treatment
Number of Patients With Local Disease Control	Number of patients with no disease progression as measured by tumor imaging, based on RECIST criteria	12 months after treatment
Change From Baseline in Patient Reported Outcomes Using FACT-Hepatobiliary (FACT-Hep) Quality of Life Questionnaire.	The Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) is an instrument that assesses health-related quality of life in patients with hepatobiliary cancers. The FACT-Hep consists of the FACT-G, which assesses generic health-related quality of life and concerns, and a validated Hepatobiliary Subscale (HS), which assesses disease-specific issues. Responses are on a 5 point Likert-type scale; items are summed to generate scores, with higher scores indicating better QOL (possible range of total score = 0-180).	12 months after treatment

Collaborators and Investigators

• Sponsor: University of Chicago
• Investigators: Principal Investigator: Stanley Liauw, MD, University of Chicago

Study record dates

Study Major Dates

• Study Start (Actual): April 14, 2009
• Primary Completion (Actual): August 1, 2020
• Study Completion (Actual): June 1, 2022

Study Registration Dates

• First Submitted: April 15, 2011
• First Submitted That Met QC Criteria: April 25, 2011
• First Posted (Estimated): April 27, 2011

Study Record Updates

• Last Update Posted (Actual): July 18, 2025
• Last Update Submitted That Met QC Criteria: June 30, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Pancreatic Cancer; Stereotactic Radiation
• Additional Relevant MeSH Terms: Endocrine System Diseases; Neoplasms by Site; Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms
• Other Study ID Numbers: 16866B