Lattice Stereotactic Body Radiation Therapy (Lattice SBRT) for Localized Unresectable or Metastatic Conventional Type Chondrosarcoma
Primary Purpose
Metastatic Chondrosarcoma
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Lattice stereotactic body radiation therapy
Sponsored by
About this trial
This is an interventional treatment trial for Metastatic Chondrosarcoma
Eligibility 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).
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Lattice stereotactic body radiation therapy
Arm Description
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.
Outcomes
Primary Outcome Measures
Incidence of treatment related grade 3 or higher non-hematologic adverse events
-As scored by NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5
Secondary Outcome Measures
Full Information
NCT ID
NCT04098887
First Posted
September 19, 2019
Last Updated
September 11, 2020
Sponsor
Washington University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT04098887
Brief Title
Lattice Stereotactic Body Radiation Therapy (Lattice SBRT) for Localized Unresectable or Metastatic Conventional Type Chondrosarcoma
Official Title
A Phase I Trial of Lattice Stereotactic Body Radiation Therapy (Lattice SBRT) for Localized Unresectable or Metastatic Conventional Type Chondrosarcoma
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Withdrawn
Why Stopped
Investigator decided to not go forward with the study.
Study Start Date
October 31, 2020 (Anticipated)
Primary Completion Date
November 30, 2021 (Anticipated)
Study Completion Date
November 30, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Chondrosarcoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lattice stereotactic body radiation therapy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Radiation
Intervention Name(s)
Lattice stereotactic body radiation therapy
Other Intervention Name(s)
Lattice SBRT
Intervention Description
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).
Primary Outcome Measure Information:
Title
Incidence of treatment related grade 3 or higher non-hematologic adverse events
Description
-As scored by NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5
Time Frame
From start of treatment through 90 days post-treatment (approximately 3.5 months)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew Spraker, M.D., Ph.D.
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
http://www.siteman.wustl.edu
Description
Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine
Learn more about this trial
Lattice Stereotactic Body Radiation Therapy (Lattice SBRT) for Localized Unresectable or Metastatic Conventional Type Chondrosarcoma
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