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Stereotactic Body Radiotherapy Dose Escalation in Pancreatic Cancer | Clinical Trials | Clareo Health

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Stereotactic Body Radiotherapy Dose Escalation in Pancreatic Cancer

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

NCT02454140•University of California, San Diego

Summary

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

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

Locations (1)

UCSD Moores Cancer Center

La Jolla, California, United States

Key Dates

Start Date

June 20, 2014

Primary Completion Date

December 31, 2022

Completion Date

December 31, 2022

Last Updated

September 12, 2025

Enrollment

ACTUAL participants

Conditions

Pancreatic Cancer

Interventions

SBRT

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 12, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Stereotactic Body Radiotherapy Dose Escalation in Pancreatic Cancer

Inclusion Criteria

Exclusion Criteria

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