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Lattice Stereotactic Body Radiation Therapy (Lattice SBRT) for Localized Unresectable or Metastatic Conventional Type Chondrosarcoma

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: NCT04098887
Recruitment Status : Not yet recruiting
First Posted : September 23, 2019
Last Update Posted : March 9, 2020
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

Brief Summary:
Unresectable (including metastatic) conventional chondrosarcoma requires high dose radiation for local control. Radiation Oncologists have traditionally used long radiation courses and concern for toxicity to surrounding organs at risk. Stereotactic body radiation therapy (SBRT) has the ability to deliver high doses of radiation in a manner that may improve clinical response but has size limitations. SBRT delivered with lattice radiotherapy (LRT) may safely dose escalate smaller portions of the tumor and also provide improved cancer control. This study is to evaluate the safety and initial efficacy of this treatment approach.

Condition or disease Intervention/treatment Phase
Metastatic Chondrosarcoma Radiation: Lattice stereotactic body radiation therapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Trial of Lattice Stereotactic Body Radiation Therapy (Lattice SBRT) for Localized Unresectable or Metastatic Conventional Type Chondrosarcoma
Estimated Study Start Date : June 30, 2020
Estimated Primary Completion Date : July 31, 2021
Estimated Study Completion Date : July 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Lattice stereotactic body radiation therapy
Patients with up to 10 chondrosarcoma lesions will undergo radiotherapy to all sites of disease. For lesions less than 4.5 cm, traditional SBRT will be used. For sites 4.5 cm or greater, Lattice SBRT will be used. For Lattice SBRT, radiotherapy will be prescribed to 20 Gy in 5 fractions delivered every other day with a LATTICE simultaneous integrated boost (SIB) to 66.7 Gy in 5 fractions.
Radiation: Lattice stereotactic body radiation therapy
For Lattice SBRT, the daily prescription dose will be 20 Gy to be delivered to the PTV_2000 with a simultaneous integrated boost of 66.7 Gy to be delivered to the PTV_6670 over 5 fractions (4 Gy and 13.2 Gy to the PTV_2000 and PTV_6670, respectively).
Other Name: Lattice SBRT




Primary Outcome Measures :
  1. Incidence of treatment related grade 3 or higher non-hematologic adverse events [ Time Frame: From start of treatment through 90 days post-treatment (approximately 3.5 months) ]
    -As scored by NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5



Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically or cytologically confirmed conventional chondrosarcoma.
  • At least one, large targetable lesion defined as: 1 lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥ 45 mm with radiographic imaging or with calipers by clinical exam.
  • Deemed metastatic and/or unresectable by multidisciplinary review. Patients with prior resection with gross residual disease that are subsequently deemed ineligible for further resection are allowed.
  • Patients that have had prior chemotherapy are allowed
  • At least 14 years of age
  • ECOG performance status ≤ 2
  • Normal bone marrow and organ function as defined below:

    • Leukocytes ≥ 3,000/mcL
    • Absolute neutrophil count ≥ 1,500/mcl
    • Platelets ≥ 100,000/mcl
  • 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:

  • Dedifferentiated chondrosarcoma and extra-skeletal myxoid chondrosarcoma are excluded.
  • Patients with greater than 5 measurable metastatic lesions as determined by multidisciplinary review are excluded
  • Prior radiotherapy that overlaps with any planned site of protocol radiotherapy.
  • 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.
  • 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): NCT04098887


Contacts
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Contact: Matthew Spraker, M.D., Ph.D. 314-362-8567 mspraker@wustl.edu
Contact: Sai Duriseti, M.D., Ph.D. 314-565-3032 durisetiks@wustl.edu

Locations
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United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
Contact: Matthew Spraker, M.D., Ph.D.    314-362-8567    mspraker@wustl.edu   
Contact: Sai Duriseti, M.D., Ph.D.    314-565-3032    durisetiks@wustl.edu   
Principal Investigator: Matthew Spraker, M.D., Ph.D.         
Sub-Investigator: Sai Duriseti, M.D., Ph.D.         
Sub-Investigator: Aadel Chaudhuri, M.D., Ph.D.         
Sub-Investigator: Jeff Szymanski, M.D., Ph.D.         
Sub-Investigator: Angela Hirbe, M.D.         
Sub-Investigator: Clifford Robinson, M.D.         
Sub-Investigator: Cara Cipriano, M.D.         
Sub-Investigator: Douglas McDonald, M.D.         
Sub-Investigator: Regis O'Keefe, M.D.         
Sub-Investigator: Jacob Buchowski, M.D., M.S.         
Sub-Investigator: Matthew Goodwin, M.D., Ph.D.         
Sub-Investigator: John Chrisinger, M.D.         
Sub-Investigator: Yu Tao, M.D., M.S.         
Sub-Investigator: Jeff Michalski, M.D.         
Sub-Investigator: Brian Van Tine, M.D., Ph.D.         
Sub-Investigator: Dennis Hallahan, M.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: NCT04098887    
Other Study ID Numbers: 19-x296
First Posted: September 23, 2019    Key Record Dates
Last Update Posted: March 9, 2020
Last Verified: March 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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Chondrosarcoma
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Sarcoma