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Palliative Lattice Stereotactic Body Radiotherapy (SBRT)

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ClinicalTrials.gov Identifier: NCT04133415
Recruitment Status : Not yet recruiting
First Posted : October 21, 2019
Last Update Posted : October 21, 2019
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

Brief Summary:
Standard palliative radiotherapy regimens may provide limited durability of response in large tumors. Thus, there is a clinical need for a new approach. The Lattice SBRT approach will deliver 20 Gy in 5 fractions with partial volume simultaneous integrated boosts to 66.7 Gy. This is hypothesized to improve symptom response, local control, and better prime the tumor microenvironment for immune response compared with standard palliative radiotherapy doses. It is also hypothesized that this will be associated with less toxicity than the traditional homogenous SBRT plan delivered to a large tumor. Blood will be collected before and after Lattice SBRT for evaluation of the peripheral blood immune microenvironment.

Condition or disease Intervention/treatment Phase
Cancer Palliative Radiotherapy Radiation: Lattice stereotactic body radiation therapy Procedure: Peripheral blood Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Trial of Palliative Lattice Stereotactic Body Radiotherapy (SBRT)
Estimated Study Start Date : December 31, 2019
Estimated Primary Completion Date : February 28, 2021
Estimated Study Completion Date : February 28, 2021

Arm Intervention/treatment
Experimental: Lattice stereotactic body radiation therapy
-Lattice SBRT prescribed to a dose of 20 Gy in 5 fractions with a simultaneous integrated boosts of 66.7 Gy in 5 fractions
Radiation: Lattice stereotactic body radiation therapy
-As long as radiotherapy fields do not overlap, treatment of up to 4 other tumor sites are allowed
Other Name: Lattice SBRT

Procedure: Peripheral blood
-Before treatment, immediately after radiotherapy completion, 14 days after radiotherapy, and 30 days after radiotherapy




Primary Outcome Measures :
  1. Percentage of patients with treatment-related, non-hematologic, grade 3 or higher adverse events [ Time Frame: Through 90 days following completion of radiotherapy (estimated to be 90 days and 2 weeks) ]
    -Measured by CTCAE version 5.0



Information from the National Library of Medicine

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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:

  • Histologically or cytologically confirmed cancer.
  • Planning to undergo palliative radiotherapy to a lesion ≥ 4.5 cm as measured with radiographic imaging or with calipers by clinical exam.
  • ECOG performance status ≤ 2
  • At least 18 years of age.
  • Radiotherapy is known to be teratogenic. For this reason, women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of the study, and 6 months after completion of the study
  • Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).

Exclusion Criteria:

  • Prior radiotherapy that overlaps with any planned site of protocol radiotherapy.
  • Patients with tumors in need of urgent surgical intervention, such as life-threatening bleeding or those at high risk for pathologic fracture.
  • Currently receiving any systemic cancer therapy agents. Systemic therapy prior to radiotherapy or planned after radiotherapy delivery are allowed at the discretion of the treating radiation oncologist with a suggested 2 week wash out period..
  • Pregnant and/or breastfeeding. Women of childbearing potential must have a negative pregnancy test within 20 days of study entry.
  • Patients with HIV are eligible unless their CD4+ T-cell counts are < 350 cells/mcL or they have a history of AIDS-defining opportunistic infection within the 12 months prior to registration. Concurrent treatment with effective ART according to DHHS treatment guidelines is recommended. Recommend exclusion of specific ART agents based on predicted drug-drug interactions (i.e. for sensitive CYP3A4 substrates, concurrent strong CYP3A4 inhibitors (ritonavir and cobicistat) or inducers (efavirenz) should be contraindicated).

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): NCT04133415


Contacts
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Contact: Matthew Spraker, M.D., Ph.D. 314-362-8567 mspraker@wustl.edu

Locations
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United States, Missouri
Washington University School of Medicine Not yet recruiting
Saint Louis, Missouri, United States, 63110
Contact: Matthew Spraker, M.D., Ph.D.    314-362-8567    mspraker@wustl.edu   
Principal Investigator: Matthew Spraker, M.D., Ph.D.         
Sub-Investigator: Clifford Robinson, M.D.         
Sub-Investigator: Jeff Michalski, M.D.         
Sub-Investigator: Wade Thorstad, M.D.         
Sub-Investigator: Julie Schwarz, M.D., Ph.D.         
Sub-Investigator: Perry Grigsby, M.D.         
Sub-Investigator: Hyun Kim, M.D.         
Sub-Investigator: Chris Abraham, M.D.         
Sub-Investigator: Brian Van Tine, M.D., Ph.D.         
Sub-Investigator: Yu Tao, M.D., M.S.         
Sub-Investigator: Dennis Hallahan, M.D.         
Sub-Investigator: Aadel Chaudhuri, M.D., Ph.D.         
Sub-Investigator: Jeff Szymanski, M.D., Ph.D.         
Sponsors and Collaborators
Washington University School of Medicine
Investigators
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Principal Investigator: Matthew Spraker, M.D., Ph.D. Washington University School of Medicine

Additional Information:
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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT04133415     History of Changes
Other Study ID Numbers: 201910071
First Posted: October 21, 2019    Key Record Dates
Last Update Posted: October 21, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No