Metastatic ChondrosarcomaNCT04098887
Lattice Stereotactic Body Radiation Therapy (Lattice SBRT) for Localized Unresectable or Metastatic Conventional Type Chondrosarcoma
A study testing Lattice stereotactic body radiation therapy in people with Metastatic Chondrosarcoma, run by Washington University School of Medicine.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Metastatic Chondrosarcoma
- What is being tested?
- Lattice stereotactic body radiation therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 31 Oct 2020to 30 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Show all 12Show fewer
- 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).
Who cannot join
- 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).
About this study
Official title: A Phase I Trial of Lattice Stereotactic Body Radiation Therapy (Lattice SBRT) for Localized Unresectable or Metastatic Conventional Type Chondrosarcoma
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.
- Conditions
- Metastatic Chondrosarcoma
- Being tested
- Lattice stereotactic body radiation therapy
- Medical subject headings
- Chondrosarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lattice stereotactic body radiation therapyRadiation
Also called Lattice SBRT
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).
| Study group | Role | What they receive |
|---|---|---|
| Lattice stereotactic body radiation therapy | Experimental | 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. Receives: Radiation: Lattice stereotactic body radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From start of treatment through 90 days post-treatment (approximately 3.5 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2019
- Study start31 Oct 2020 (estimated)
- Primary completion30 Nov 2021 (estimated)
- Study completion30 Nov 2021 (estimated)
Why it stopped: Investigator decided to not go forward with the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic ChondrosarcomaStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matthew Spraker, M.D., Ph.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04098887
- Sponsor's protocol ID
- 19-x296
- Status last verified
- Sep 2020
- First submitted
- 19 Sep 2019
- Last updated
- 16 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Trial of Lattice Stereotactic Body Radiation Therapy (Lattice SBRT) for Localized Unresectable or Metastatic Conventional Type Chondrosarcoma
- ClinicalTrials.gov ID
- NCT04098887
- Acronym / sponsor ID
- 19-x296
- Conditions
- Metastatic Chondrosarcoma
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Investigator decided to not go forward with the study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 31 Oct 2020 (estimated)
- Primary completion
- 30 Nov 2021 (estimated)
- Study completion
- 30 Nov 2021 (estimated)
- First posted
- 23 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lattice stereotactic body radiation therapy | Experimental | Radiation: Lattice stereotactic body radiation therapyPatients 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. |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lattice stereotactic body radiation therapyAlso: Lattice SBRTFor 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). | Radiation | Lattice stereotactic body radiation therapy |
Primary outcome
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2020.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew Spraker, M.D., Ph.D. principal investigator
Washington University School of Medicine
Questions about this trial
What is this clinical trial studying?
A study testing Lattice stereotactic body radiation therapy in people with Metastatic Chondrosarcoma, run by Washington University School of Medicine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 16 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2020.