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Stereotactic Body Radiotherapy Dose Escalation in Pancreatic Cancer (SBRT)

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ClinicalTrials.gov Identifier: NCT02454140
Recruitment Status : Recruiting
First Posted : May 27, 2015
Last Update Posted : July 30, 2019
Sponsor:
Information provided by (Responsible Party):
James D. Murphy, MD, MS, University of California, San Diego

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

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Radiation: SBRT Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Phase I Trial of Adaptive Stereotactic Body Radiotherapy (SBRT) Dose Escalation in Pancreatic Cancer
Actual Study Start Date : June 20, 2014
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


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 :
  1. Maximum Tolerated Dose [ Time Frame: From date of randomization to observed dose limiting toxicity (DLT) in 20% of patients assessed up to 3 years ]
    The purpose of this study is to determine the maximum tolerated dose of five fraction stereotactic radiotherapy (SBRT) in pancreatic cancer.


Secondary Outcome Measures :
  1. Local Tumor Progression [ 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 ]
    local tumor control remains a crucial part of treatment for patients with pancreatic cancer who are not candidates for curative therapy.

  2. Distant Metastatic Progression Rate [ 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 ]
    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.

  3. Overall Survival [ Time Frame: From date of diagnosis and SBRT to date of death assessed over 3 years ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02454140


Contacts
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Contact: Shakeela Dad, PhD (858) 822-822-5376 sdad@ucsd.edu
Contact: Derrik Watson, BA (858) 657-7520 derrikw@ucsd.edu

Locations
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United States, California
UCSD Moores Cancer Center Recruiting
La Jolla, California, United States, 92093
Sponsors and Collaborators
University of California, San Diego
Investigators
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Principal Investigator: James D Murphy, MD University of California, San Diego

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Responsible Party: James D. Murphy, MD, MS, Associate Clinical Professor, Radiation Medicine, University of California, San Diego
ClinicalTrials.gov Identifier: NCT02454140     History of Changes
Other Study ID Numbers: 140103
First Posted: May 27, 2015    Key Record Dates
Last Update Posted: July 30, 2019
Last Verified: July 2019
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases