Stereotactic Body Radiotherapy Dose Escalation in Pancreatic Cancer

NCT02454140 | Completed Results DMC

• 1 other identifier: 140103
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• Maximum Tolerated Dose

  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

Study Arms (5)

Cohort 1

EXPERIMENTAL

SBRT 40 Gy in 5 fractions

Radiation: SBRT

Cohort 2

EXPERIMENTAL

SBRT 45 Gy in 5 fractions (starting dose level)

Radiation: SBRT

Cohort 3

EXPERIMENTAL

SBRT 50 Gy in 5 fractions

Radiation: SBRT

Cohort 4

EXPERIMENTAL

SBRT 55 Gy in 5 fractions

Radiation: SBRT

Cohort 5

EXPERIMENTAL

SBRT 60 Gy in 5 fractions

Radiation: SBRT

Interventions

SBRT RADIATION

Fixed five-fraction stereotactic radiotherapy

Cohort 1; Cohort 2; Cohort 3; Cohort 4; Cohort 5

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

UCSD Moores Cancer Center

La Jolla, California, 92093, 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. James D. Murphy
• Organization: University of California, San Diego

j2murphy@health.ucsd.edu

(858) 822-6040

Study Officials

• James D Murphy, MD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Clinical Professor, Radiation Medicine

Study Record Dates

• First Submitted: January 11, 2015
• First Posted: May 27, 2015
• Study Start: June 20, 2014
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: September 12, 2025
• Results First Posted: September 12, 2025

Record last verified: 2025-08

Locations

US (1)