Stereotactic Body Radiotherapy Dose Escalation in Pancreatic Cancer

NCT ID: NCT02454140

Last Updated: 2025-09-12

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-20

Study Completion Date

2022-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Pancreatic Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Cohort 1

SBRT 40 Gy in 5 fractions

Group Type EXPERIMENTAL

SBRT

Intervention Type RADIATION

Fixed five-fraction stereotactic radiotherapy

Cohort 2

SBRT 45 Gy in 5 fractions (starting dose level)

Group Type EXPERIMENTAL

SBRT

Intervention Type RADIATION

Fixed five-fraction stereotactic radiotherapy

Cohort 3

SBRT 50 Gy in 5 fractions

Group Type EXPERIMENTAL

SBRT

Intervention Type RADIATION

Fixed five-fraction stereotactic radiotherapy

Cohort 4

SBRT 55 Gy in 5 fractions

Group Type EXPERIMENTAL

SBRT

Intervention Type RADIATION

Fixed five-fraction stereotactic radiotherapy

Cohort 5

SBRT 60 Gy in 5 fractions

Group Type EXPERIMENTAL

SBRT

Intervention Type RADIATION

Fixed five-fraction stereotactic radiotherapy

Interventions

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SBRT

Fixed five-fraction stereotactic radiotherapy

Intervention Type RADIATION

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of California, San Diego

OTHER

Sponsor Role lead

Responsible Party

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James D. Murphy, MD, MS

Associate Clinical Professor, Radiation Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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James D Murphy, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Diego

Locations

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UCSD Moores Cancer Center

La Jolla, California, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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140103

Identifier Type: -

Identifier Source: org_study_id

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