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Stereotactic Body Radiotherapy Dose Escalation in Pancreatic Cancer (SBRT)

Primary Purpose

Pancreatic Cancer

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SBRT
Sponsored by
University of California, San Diego
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Pancreatic Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • UCSD Moores Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Cohort 1

Cohort 2

Cohort 3

Cohort 4

Cohort 5

Arm Description

SBRT 40 Gy in 5 fractions

SBRT 45 Gy in 5 fractions (starting dose level)

SBRT 50 Gy in 5 fractions

SBRT 55 Gy in 5 fractions

SBRT 60 Gy in 5 fractions

Outcomes

Primary Outcome Measures

Maximum Tolerated Dose
The purpose of this study is to determine the maximum tolerated dose of five fraction stereotactic radiotherapy (SBRT) in pancreatic cancer.

Secondary Outcome Measures

Local Tumor Progression
local tumor control remains a crucial part of treatment for patients with pancreatic cancer who are not candidates for curative therapy.
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.
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.

Full Information

First Posted
January 11, 2015
Last Updated
May 18, 2022
Sponsor
University of California, San Diego
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1. Study Identification

Unique Protocol Identification Number
NCT02454140
Brief Title
Stereotactic Body Radiotherapy Dose Escalation in Pancreatic Cancer
Acronym
SBRT
Official Title
Phase I Trial of Adaptive Stereotactic Body Radiotherapy (SBRT) Dose Escalation in Pancreatic Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 20, 2014 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Diego

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1
Arm Type
Experimental
Arm Description
SBRT 40 Gy in 5 fractions
Arm Title
Cohort 2
Arm Type
Experimental
Arm Description
SBRT 45 Gy in 5 fractions (starting dose level)
Arm Title
Cohort 3
Arm Type
Experimental
Arm Description
SBRT 50 Gy in 5 fractions
Arm Title
Cohort 4
Arm Type
Experimental
Arm Description
SBRT 55 Gy in 5 fractions
Arm Title
Cohort 5
Arm Type
Experimental
Arm Description
SBRT 60 Gy in 5 fractions
Intervention Type
Radiation
Intervention Name(s)
SBRT
Intervention Description
Fixed five-fraction stereotactic radiotherapy
Primary Outcome Measure Information:
Title
Maximum Tolerated Dose
Description
The purpose of this study is to determine the maximum tolerated dose of five fraction stereotactic radiotherapy (SBRT) in pancreatic cancer.
Time Frame
From date of randomization to observed dose limiting toxicity (DLT) in 20% of patients assessed up to 3 years
Secondary Outcome Measure Information:
Title
Local Tumor Progression
Description
local tumor control remains a crucial part of treatment for patients with pancreatic cancer who are not candidates for curative therapy.
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
Title
Distant Metastatic Progression Rate
Description
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.
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
Title
Overall Survival
Description
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.
Time Frame
From date of diagnosis and SBRT to date of death assessed over 3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James D Murphy, MD
Organizational Affiliation
University of California, San Diego
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCSD Moores Cancer Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Stereotactic Body Radiotherapy Dose Escalation in Pancreatic Cancer

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