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

NCT01342354 | Completed Phase 1 Results

• 1 other identifier: 16866B
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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

Keywords

Pancreatic Cancer; Stereotactic Radiation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• The Number of Patients With Late (>28 Days) Grade 3+ GI Toxicity

  12 months after treatment

• Number of Participants With an Improvement in Patient Reported Pain Score Using Visual Analog Scale

  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

  12 months after treatment

• Change From Baseline in Patient Reported Outcomes Using FACT-Hepatobiliary (FACT-Hep) Quality of Life Questionnaire.

  12 months after treatment

Study Arms (3)

Stereotactic Radiation: 10 Gy x3

EXPERIMENTAL

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

Radiation: Stereotactic Radiation 10 Gy

Stereotactic Radiation: 12.5 Gy x3

EXPERIMENTAL

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

Radiation: Stereotactic Radiation 12.5 Gy

Stereotactic Radiation: 15 Gy x3

EXPERIMENTAL

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

Radiation: Stereotactic Radiation 15 Gy

Interventions

Stereotactic Radiation 10 Gy RADIATION

10 Gy three times over 10 days

Stereotactic Radiation: 10 Gy x3

Stereotactic Radiation 12.5 Gy RADIATION

12.5 Gy three times over 10 days

Stereotactic Radiation: 12.5 Gy x3

Stereotactic Radiation 15 Gy RADIATION

15 Gy three times over 10 days

Stereotactic Radiation: 15 Gy x3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Dr. Stanley Liauw
• Organization: The University of Chicago

Stanley.Liauw@uchospitals.edu

(773) 702-0817

Study Officials

• Stanley Liauw, MD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2011
• First Posted: April 27, 2011
• Study Start: April 14, 2009
• Primary Completion: August 1, 2020
• Study Completion: June 1, 2022
• Last Updated: July 18, 2025
• Results First Posted: July 18, 2025

Record last verified: 2025-06

Locations

US (1)