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

August 6, 2024 updated by: Washington University School of Medicine

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
70

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 Names:
  • SBRT
Procedure: Research blood draw
-Baseline, immediately after radiotherapy completion (fraction 5), 14 days after radiotherapy, and 30 day follow-up

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Rate of Local Control
Time Frame: At 6 months
At 6 months
Number of Participants With Treatment-related, Non-hematologic Grade ≥ 3 Toxicity
Time Frame: Through 6 months
-Graded using CTCAE v5.0
Through 6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
  • 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.
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
  • 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
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
  • 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
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
  • 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.
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
  • 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.
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
  • 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
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
  • 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
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
  • 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
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
  • 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
Baseline, 2 weeks post-treatment (approximately week 4), 30 days, 3 months, 6 months, and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Washington University School of Medicine

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Goldman Sachs Foundation (Emerson Collective)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Pamela Samson, M.D., Washington University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 22, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 4, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 9, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 16, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 17, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 29, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 6, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 202009022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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