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Palliative Lattice Stereotactic Body Radiotherapy (SBRT) for Patients With Sarcoma, Thoracic, Abdominal, and Pelvic Cancers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04553471
Recruitment Status : Recruiting
First Posted : September 17, 2020
Last Update Posted : September 28, 2020
Sponsor:
Collaborator:
Goldman Sachs Foundation (Emerson Collective)
Information provided by (Responsible Party):
Washington University School of Medicine

Brief Summary:
This is a study evaluating the safety and efficacy of Lattice SBRT for patients with large tumors (≥ 4.5 cm) planning to undergo palliative radiotherapy.

Condition or disease Intervention/treatment Phase
Sarcoma Thoracic Cancer Abdominal Cancer Pelvic Cancer Radiation: Stereotactic body radiotherapy Procedure: Research blood draw Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: At least 10 participants will be enrolled in each cohort (soft tissue sarcomas, thoracic cancers, abdominal, and pelvic cancers).
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Trial of Palliative Lattice Stereotactic Body Radiotherapy (SBRT) for Patients With Sarcoma, Thoracic, Abdominal, and Pelvic Cancers
Actual Study Start Date : September 22, 2020
Estimated Primary Completion Date : August 31, 2022
Estimated Study Completion Date : January 31, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: SBRT
5-fraction Lattice SBRT delivered to 20 Gy with a simultaneous integrated boost (SIB) to 66.7 Gy.
Radiation: Stereotactic body radiotherapy
Treatment will take approximately 2 weeks.
Other Name: SBRT

Procedure: Research blood draw
-Baseline, immediately after radiotherapy completion (fraction 5), 14 days after radiotherapy, and 30 day follow-up




Primary Outcome Measures :
  1. Rate of local control [ Time Frame: 6 months ]
  2. Proportion of participants with treatment-related grade 3 or higher CTCAE v5.0 toxicity [ Time Frame: Within 6 months of completion of treatment (estimated to be 6 months and 2 weeks) ]

Secondary Outcome Measures :
  1. Proportion of participants with treatment-related grade 3 or higher CTCAE v5.0 toxicity [ Time Frame: 12 months ]
  2. Patient reported toxicity as measured by PRO-CTCAE assessment [ Time Frame: Baseline, 2 weeks post-treatment (approximately week 4), 30 days, 3 months, 6 months, and 12 months ]
    -The PRO-CTCAE Measurement System characterizes the frequency, severity, interference, and presence/absence of symptomatic toxicities

  3. Quality of life as measured by PROMIS physical function assessment [ Time Frame: Baseline, 2 weeks post-treatment (approximately week 4), 30 days, 3 months, 6 months, and 12 months ]
    • 10-item questionnaire assessing current self-reported physical function
    • Answers range from 1-cannot do to 5=not at all/without any difficulty
    • Score ranges from 10-50 with a higher score indicating better physical function

  4. Quality of life as measured by PROMIS global health physical assessment [ Time Frame: Baseline, 2 weeks post-treatment (approximately week 4), 30 days, 3 months, 6 months, and 12 months ]
    • 2-item questionnaire assessing current self-reported overall physical function
    • Answers range from 1=poor/not all all to 5=excellent/completely
    • Score ranges from 2-10 with a higher score indicating better global health physical function

  5. Quality of life as measured by PROMIS anxiety assessment [ Time Frame: Baseline, 2 weeks post-treatment (approximately week 4), 30 days, 3 months, 6 months, and 12 months ]
    • 29-item questionnaire assessing current self-reported anxiety
    • Answers range from 1-never to 5=always
    • Score ranges from 29-145 with a lower score indicating less anxiety

  6. Quality of life as measured by PROMIS depression assessment [ Time Frame: Baseline, 2 weeks post-treatment (approximately week 4), 30 days, 3 months, 6 months, and 12 months ]
    • 4-item questionnaire assessing current self-reported depression
    • Answers range from 1=never to 5=always
    • Score ranges from 4-20 with a lower score indicating less depression

  7. Patient reported pain as measured by Numeric Pain Scale [ Time Frame: Baseline, 2 weeks post-treatment (approximately week 4), 30 days, 3 months, 6 months, and 12 months ]
    -The Numeric Pain Scale is an 11-point scale for patient self-reporting of pain



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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 sarcoma (including extremity), thoracic cancer (including esophageal), abdominal cancer (including retroperitoneal sarcoma), or pelvic 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 high-dose radiotherapy that overlaps with any planned site of protocol radiotherapy. Patients where the Lattice SBRT fields may overlap with the low dose (<10 Gy) region of prior radiotherapy treatments are eligible and may be treated if this is determined to be safe by the treating physician.
  • 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 cytotoxic cancer therapy regimens or VEGF inhibitors that will overlap with the Lattice SBRT administration.

    *Cytotoxic chemotherapy and VEGF inhibitors prior to radiotherapy or planned after radiotherapy delivery are allowed at the discretion of the treating radiation oncologist. This includes continuing a treatment plan which was initiated prior to the start of radiotherapy. A 2-week washout is recommended, but not required.

  • Pregnant. 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): NCT04553471


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 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: James Kavanaugh, M.S.         
Sub-Investigator: Sai Duriseti, M.D., Ph.D.         
Sub-Investigator: Clifford Robinson, M.D.         
Sub-Investigator: Jeff Michalski, M.D.         
Sub-Investigator: Dennis Hallahan, M.D.         
Sub-Investigator: Perry Grigsby, M.D.         
Sub-Investigator: Hyun Kim, M.D.         
Sub-Investigator: Brian Van Tine, M.D., Ph.D.         
Sub-Investigator: Aadel Chaudhuri, M.D., Ph.D.         
Sub-Investigator: Jeff Szymanski, M.D., Ph.D.         
Sub-Investigator: Dinesh Thotala, Ph.D.         
Sub-Investigator: Sreekrishna Goddu, Ph.D.         
Sub-Investigator: Nels Knutson, Ph.D.         
Sub-Investigator: Christopher Abraham, M.D.         
Sub-Investigator: Yi Huang, M.S.         
Sponsors and Collaborators
Washington University School of Medicine
Goldman Sachs Foundation (Emerson Collective)
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: NCT04553471    
Other Study ID Numbers: 202009022
First Posted: September 17, 2020    Key Record Dates
Last Update Posted: September 28, 2020
Last Verified: September 2020
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
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Sarcoma
Pelvic Neoplasms
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms by Site