Stereotactic Body Radiotherapy Dose Escalation In Pancreatic Cancer

Study Overview

Stereotactic Body Radiotherapy Dose Escalation in Pancreatic Cancer

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

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.

Pancreatic Cancer

RADIATION: SBRT

140103

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 Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2015-01-11	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2023-11-01
First Submitted that Met QC Criteria 2015-05-21	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2023-11-03
First Posted (ACTUAL) 2015-05-27	Results First Posted N/A	Last Verified 2023-11

Study Plan

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

Design Details

Primary Purpose:
Other

Allocation:
Non Randomized

Interventional Model:
Parallel

Masking:
None

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

Primary Outcome Measures	Measure Description	Time Frame
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

Secondary Outcome Measures	Measure Description	Time Frame
Local Tumor Progression	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	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	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

Contacts and Locations

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

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.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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.

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

Collaborators and Investigators

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

Investigators

PRINCIPAL_INVESTIGATOR: James D Murphy, MD, University of California, San Diego

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

Learn

Resources

PatientS

Caregivers

Clinical Trial Record