Stereotactic Body Radiotherapy Dose Escalation in Pancreatic Cancer (SBRT)

August 22, 2025 updated by: James D. Murphy, MD, MS, University of California, San Diego

Phase I Trial of Adaptive Stereotactic Body Radiotherapy (SBRT) Dose Escalation in Pancreatic Cancer

This study is to determine the maximum tolerated dose (MTD) of five fraction stereotactic radiotherapy (SBRT) in pancreatic cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This trial is designed to find the maximum tolerated dose of radiation under a fixed 5-fraction SBRT regimen escalating the dose from 40 Gy in 5 fractions, to 60 Gy in 5 fractions, at 5 Gy intervals.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • La Jolla, California, United States, 92093
        • UCSD Moores Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Diagnosis: Histologically-proven invasive adenocarcinoma of the pancreas.
  • Disease Status: Medically unresectable (any stage), or locally advanced (stage III).
  • Tumor Location: Primary tumor may be located anywhere in the pancreas.
  • Treatment eligibility: The patient must be able to have fiducial markers implanted into the pancreatic tumor, and receive radiation regimen as specified in the protocol.
  • Performance Level: Karnofsky Performance Status ≥ 60
  • Adequate Renal Function Defined As: Serum creatinine ≤ 1.5 x upper limit of normal
  • Informed Consent: All subjects must sign a written informed consent.

Exclusion Criteria:

  • Pregnancy or Breast-Feeding: Pregnant or breast-feeding women will not be entered on this study due to risks of fetal and teratogenic adverse events. (Note: Serum Pregnancy tests must be obtained in women of child bearing potential). Sexually active females may not participate unless they have agreed to use an effective contraceptive method (such as abstinence, diaphragm, condom, or intrauterine device) to prevent pregnancy for the duration of the study.
  • Life expectancy < 6 months
  • The patient cannot have had prior radiation therapy to the thorax or upper abdomen.
  • Incarcerated individuals
  • Subjects unable to give informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort 1
SBRT 40 Gy in 5 fractions
Radiation: SBRT
Fixed five-fraction stereotactic radiotherapy
Experimental: Cohort 2
SBRT 45 Gy in 5 fractions (starting dose level)
Radiation: SBRT
Fixed five-fraction stereotactic radiotherapy
Experimental: Cohort 3
SBRT 50 Gy in 5 fractions
Radiation: SBRT
Fixed five-fraction stereotactic radiotherapy
Experimental: Cohort 4
SBRT 55 Gy in 5 fractions
Radiation: SBRT
Fixed five-fraction stereotactic radiotherapy
Experimental: Cohort 5
SBRT 60 Gy in 5 fractions
Radiation: SBRT
Fixed five-fraction stereotactic radiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum Tolerated Dose
Time Frame: From date of randomization to observed dose limiting toxicity (DLT) in 20% of patients assessed up to 3 years
The purpose of this study is to determine the maximum tolerated dose of five fraction stereotactic radiotherapy (SBRT) in pancreatic cancer.
From date of randomization to observed dose limiting toxicity (DLT) in 20% of patients assessed up to 3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Local Tumor Progression
Time Frame: From date of randomization until local disease progression defined as a ≥20% increase in size on CT compared with CT prior to SBRT assessed over 3 years
local tumor control remains a crucial part of treatment for patients with pancreatic cancer who are not candidates for curative therapy.
From date of randomization until local disease progression defined as a ≥20% increase in size on CT compared with CT prior to SBRT assessed over 3 years
Distant Metastatic Progression Rate
Time Frame: From date of randomization until the appearance of new lesions or a ≥20% increase in size on CT of the previously noted metastatic lesions assessed over 3 years
The cumulative incidence of distant metastatic failure will be determined for all patients treating death as a competing risk. In patients initially presenting with locally advanced disease, distant disease progression will be defined as the appearance of new metastatic lesions. In patients presenting with metastatic disease, distant progression will be defined as a ≥20% increase in size on CT of the previously noted metastatic lesions.
From date of randomization until the appearance of new lesions or a ≥20% increase in size on CT of the previously noted metastatic lesions assessed over 3 years
Overall Survival
Time Frame: From date of diagnosis and SBRT to date of death assessed over 3 years
Overall survival will be measured from the date of diagnosis through death of any cause. Survival will also be reported from the date of SBRT for comparisons to other trials in the literature. Finally, survival will be stratified by those with locally advanced disease, and those with metastatic disease on presentation.
From date of diagnosis and SBRT to date of death assessed over 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Diego

Investigators

  • Principal Investigator: James D Murphy, MD, University of California, San Diego

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 20, 2014

Primary Completion (Actual)

December 31, 2022

Study Completion (Actual)

December 31, 2022

Study Registration Dates

First Submitted

January 11, 2015

First Submitted That Met QC Criteria

May 21, 2015

First Posted (Estimated)

May 27, 2015

Study Record Updates

Last Update Posted (Estimated)

September 12, 2025

Last Update Submitted That Met QC Criteria

August 22, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 140103

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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