SarcomaNCT04553471
Palliative Lattice Stereotactic Body Radiotherapy (SBRT) for Patients With Sarcoma, Thoracic, Abdominal, and Pelvic Cancers
A study testing Stereotactic body radiotherapy and Research blood draw in people with Sarcoma and Thoracic Cancer, run by Washington University School of Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sarcoma, Thoracic Cancer, Abdominal Cancer
- What is being tested?
- Stereotactic body radiotherapy and Research blood draw
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Sep 2020to 4 May 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: A Trial of Palliative Lattice Stereotactic Body Radiotherapy (SBRT) for Patients With Sarcoma, Thoracic, Abdominal, and Pelvic Cancers
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.
- Conditions
- Sarcoma, Thoracic Cancer, Abdominal Cancer, Pelvic Cancer
- Being tested
- Stereotactic body radiotherapy, Research blood draw
- Medical subject headings
- Sarcoma, Pelvic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic body radiotherapyRadiation
Also called SBRT
Treatment will take approximately 2 weeks.
Research blood drawProcedure or surgery
-Baseline, immediately after radiotherapy completion (fraction 5), 14 days after radiotherapy, and 30 day follow-up
| Study group | Role | What they receive |
|---|---|---|
| SBRT | Experimental | 5-fraction Lattice SBRT delivered to 20 Gy with a simultaneous integrated boost (SIB) to 66.7 Gy. Receives: Radiation: Stereotactic body radiotherapy; Procedure: Research blood draw |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Local Control
Measured: At 6 months
Number of Participants With Treatment-related, Non-hematologic Grade ≥ 3 Toxicity
-Graded using CTCAE v5.0
Measured: Through 6 months
Secondary outcomes (9)
Mean Change From Baseline - PROMIS Physical Function Assessment
- Each value is the mean of the changes from baseline PROMIS T-Score to timepoint PROMIS T-score.
- PROMIS Physical Function is a 10-item questionnaire assessing current self-reported physical function with answers ranging from 1 = cannot do to 5 = not at all/without any difficulty.
- A PROMIS T-Score of 50 corresponds to the mean of the general population. A magnitude of 10 on the PROMIS scale corresponds to a standard deviation.
- A high T-Score for PROMIS Physical Function Assessment correlates to a higher physical function, or positive outcome. Since the scale is standardized a score of 60 is one standard deviation higher, or better functioning, than the reference population mean.
Measured: 2 weeks post-treatment (approximately week 4), 30 days, 3 months, 6 months, and 12 months
Mean Change From Baseline-PROMIS Global Health Physical Assessment
- Each value is the mean of the changes from baseline PROMIS T-Score to timepoint PROMIS T-score.
- PROMIS Global Health is a 2-item questionnaire assessing current self-reported physical function with answers ranging from 1=poor/not all all to 5=excellent/completely
- A PROMIS T-Score of 50 corresponds to the mean of the general population. A magnitude of 10 on the PROMIS scale corresponds to a standard deviation.
- A high T-Score for PROMIS Global Health Physical Assessment correlates to a higher global health physical assessment, or positive outcome. Since the scale is standardized a score of 60 is one standard deviation higher, or better physical assessment, than the reference population mean
Measured: 2 weeks post-treatment (approximately week 4), 30 days, 3 months, 6 months, and 12 months
Mean Change From Baseline-PROMIS Depression Assessment
- Each value is the mean of the changes from baseline PROMIS T-Score to timepoint PROMIS T-score.
- PROMIS Depression is a 4-item questionnaire assessing current self-reported depression with answers ranging from 1=never to 5=always
- A PROMIS T-Score of 50 corresponds to the mean of the general population. A magnitude of 10 on the PROMIS scale corresponds to a standard deviation.
- A high T-Score for PROMIS Depression Assessment correlates to more depression, or negative outcome. Since the scale is standardized a score of 60 is one standard deviation higher, or worse depression, than the reference population mean
Measured: 2 weeks post-treatment (approximately week 4), 30 days, 3 months, 6 months, and 12 months
Mean Change From Baseline-PROMIS Anxiety Assessment
- Each value is the mean of the changes from baseline PROMIS T-Score to timepoint PROMIS T-score.
- PROMIS Anxiety is a 29-item questionnaire assessing current self-reported anxiety with answers ranging from 1=never to 5=always
- A PROMIS T-Score of 50 corresponds to the mean of the general population. A magnitude of 10 on the PROMIS scale corresponds to a standard deviation.
- A high T-Score for PROMIS Anxiety Assessment correlates to more anxiety, or negative outcome. Since the scale is standardized a score of 60 is one standard deviation higher, or worse anxiety, than the reference population mean.
Measured: 2 weeks post-treatment (approximately week 4), 30 days, 3 months, 6 months, and 12 months
Mean Change From Baseline-Numeric Pain Scale
- Each value is the mean of the changes from baseline Numeric Pain Scale score to timepoint Numeric Pain Scale score.
- The Numeric Pain Scale is an 11-point scale for patient self-reporting of pain
- The Numeric Pain Rating Scale (NPRS) measures pain intensity in adults using a scale from 0 or "no pain" to 10 or "worst possible pain." This measure is unidimensional and evaluated on the 0-10 scale. A higher value on the scale correlates with a worse pain and a worse outcome.
Measured: 2 weeks post-treatment (approximately week 4), 30 days, 3 months, 6 months, and 12 months
Patient Reported Toxicity as Measured by PRO-CTCAE Assessment (Gastrointestinal Cancer Sites)
- The PRO-CTCAE Measurement System characterizes the frequency, severity, interference, and presence/absence of symptomatic toxicities. The higher the score the worst the symptoms.
- Severity options include none=1, mild=2, moderate=3, severe = 4, very severe=5.
- Interference options include not at all=1, a little bit=2, somewhat=3, quite a bit=4, very much=5
- Frequency options include never=1, rarely=2, occasionally=3, frequently=4, almost constantly=5
Measured: Baseline, 2 weeks post-treatment (approximately week 4), 30 days, 3 months, 6 months, and 12 months
Patient Reported Toxicity as Measured by PRO-CTCAE Assessment (Pelvic Cancer Sites)
- The PRO-CTCAE Measurement System characterizes the frequency, severity, interference, and presence/absence of symptomatic toxicities. The higher the score the worst the symptoms.
- Severity options include none=1, mild=2, moderate=3, severe = 4, very severe=5.
- Interference options include not at all=1, a little bit=2, somewhat=3, quite a bit=4, very much=5
- How often options include 1=never, 2=rarely, 3=occasionally, 4=frequently, 5=almost constantly
- Severity of difficulty getting/keeping erection, ejaculation problems, decreased sexual interest, vaginal pain 1=none, 2=mild, 3=moderate, 4=severe, 5=very severe
- Experienced unusual vaginal discharge options include 1=not at all, 2=a little bit, 3 = somewhat, 4=quite a bit, 5=very much
Measured: Baseline, 2 weeks post-treatment (approximately week 4), 30 days, 3 months, 6 months, and 12 months
Patient Reported Toxicity as Measured by PRO-CTCAE Assessment (Sarcoma Cancer Sites)
- The PRO-CTCAE Measurement System characterizes the frequency, severity, interference, and presence/absence of symptomatic toxicities. The higher the score the worst the symptoms.
- Severity options include none=1, mild=2, moderate=3, severe = 4, very severe=5.
- Interference options include not at all=1, a little bit=2, somewhat=3, quite a bit=4, very much=5
- Frequency options include never=1, rarely=2, occasionally=3, frequently=4, almost constantly=5
Measured: Baseline, 2 weeks post-treatment (approximately week 4), 30 days, 3 months, 6 months, and 12 months
Patient Reported Toxicity as Measured by PRO-CTCAE Assessment (Thoracic Cancer Sites)
- The PRO-CTCAE Measurement System characterizes the frequency, severity, interference, and presence/absence of symptomatic toxicities. The higher the score the worst the symptoms.
- Severity options include none=1, mild=2, moderate=3, severe = 4, very severe=5.
- Interference options include not at all=1, a little bit=2, somewhat=3, quite a bit=4, very much=5
- Frequency options include never=1, rarely=2, occasionally=3, frequently=4, almost constantly=5
Measured: Baseline, 2 weeks post-treatment (approximately week 4), 30 days, 3 months, 6 months, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2020
- Study start22 Sep 2020
- Primary completion30 Sep 2022
- Study completion4 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SarcomaStudies 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
- 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)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Goldman Sachs Foundation (Emerson Collective)
- Responsible party
- Sponsor
- Investigators
- Pamela Samson, M.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04553471
- Sponsor's protocol ID
- 202009022
- Status last verified
- Aug 2024
- First submitted
- 9 Sep 2020
- Last updated
- 29 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Duriseti S, Kavanaugh J, Goddu S, Price A, Knutson N, Reynoso F, Michalski J, Mutic S, Robinson C, Spraker MB. Spatially fractionated stereotactic body radiation therapy (Lattice) for large tumors. Adv Radiat Oncol. 2021 Jan 8;6(3):100639. doi: 10.1016/j.adro.2020.100639. eCollection 2021 May-Jun.
PubMed 34195486
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Trial of Palliative Lattice Stereotactic Body Radiotherapy (SBRT) for Patients With Sarcoma, Thoracic, Abdominal, and Pelvic Cancers
- ClinicalTrials.gov ID
- NCT04553471
- Acronym / sponsor ID
- 202009022
- Conditions
- Sarcoma, Thoracic Cancer, Abdominal Cancer, Pelvic Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- Goldman Sachs Foundation (Emerson Collective)
- Study start
- 22 Sep 2020 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 4 May 2023 (actual)
- First posted
- 17 Sep 2020 (actual)
- Results
- Posted 12 Oct 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- At least 10 participants will be enrolled in each cohort (soft tissue sarcomas, thoracic cancers, abdominal, and pelvic cancers).
| Arm | Type | Receives |
|---|---|---|
| SBRT | Experimental | Radiation: Stereotactic body radiotherapy, Procedure: Research blood draw5-fraction Lattice SBRT delivered to 20 Gy with a simultaneous integrated boost (SIB) to 66.7 Gy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
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 |
|---|---|---|
| Stereotactic body radiotherapyAlso: SBRTTreatment will take approximately 2 weeks. | Radiation | SBRT |
| Research blood draw-Baseline, immediately after radiotherapy completion (fraction 5), 14 days after radiotherapy, and 30 day follow-up | Procedure or surgery | SBRT |
Primary outcome
Rate of Local Control
Time frame: At 6 months
Number of Participants With Treatment-related, Non-hematologic Grade ≥ 3 Toxicity
Time frame: Through 6 months
-Graded using CTCAE v5.0
9 secondary outcomes
Mean Change From Baseline - PROMIS Physical Function Assessment
Time frame: 2 weeks post-treatment (approximately week 4), 30 days, 3 months, 6 months, and 12 months
Mean Change From Baseline-PROMIS Global Health Physical Assessment
Time frame: 2 weeks post-treatment (approximately week 4), 30 days, 3 months, 6 months, and 12 months
Mean Change From Baseline-PROMIS Depression Assessment
Time frame: 2 weeks post-treatment (approximately week 4), 30 days, 3 months, 6 months, and 12 months
Mean Change From Baseline-PROMIS Anxiety Assessment
Time frame: 2 weeks post-treatment (approximately week 4), 30 days, 3 months, 6 months, and 12 months
Mean Change From Baseline-Numeric Pain Scale
Time frame: 2 weeks post-treatment (approximately week 4), 30 days, 3 months, 6 months, and 12 months
Patient Reported Toxicity as Measured by PRO-CTCAE Assessment (Gastrointestinal Cancer Sites)
Time frame: Baseline, 2 weeks post-treatment (approximately week 4), 30 days, 3 months, 6 months, and 12 months
Patient Reported Toxicity as Measured by PRO-CTCAE Assessment (Pelvic Cancer Sites)
Time frame: Baseline, 2 weeks post-treatment (approximately week 4), 30 days, 3 months, 6 months, and 12 months
Patient Reported Toxicity as Measured by PRO-CTCAE Assessment (Sarcoma Cancer Sites)
Time frame: Baseline, 2 weeks post-treatment (approximately week 4), 30 days, 3 months, 6 months, and 12 months
Patient Reported Toxicity as Measured by PRO-CTCAE Assessment (Thoracic Cancer Sites)
Time frame: Baseline, 2 weeks post-treatment (approximately week 4), 30 days, 3 months, 6 months, and 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34195486Duriseti S, Kavanaugh J, Goddu S, Price A, Knutson N, Reynoso F, Michalski J, Mutic S, Robinson C, Spraker MB. Spatially fractionated stereotactic body radiation therapy (Lattice) for large tumors. Adv Radiat Oncol. 2021 Jan 8;6(3):100639. doi: 10.1016/j.adro.2020.100639. eCollection 2021 May-Jun.
- 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.
Pamela Samson, M.D. principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stereotactic body radiotherapy and Research blood draw in people with Sarcoma and Thoracic Cancer, run by Washington University School of Medicine at 1 site in United States.
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 6 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: finished, as of the sponsor's last update on 29 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Yes. Results are posted in the registry (first posted 12 Oct 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Rate of Local Control (time frame: At 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04553471, which also lists 1 linked publication.
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 29 Aug 2024.