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Completed

NCT Number: NCT04553471

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.

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Key information

Conditions

Sarcoma Abdominal Cancer Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Connective and Soft Tissue Pelvic Cancer Pelvic Neoplasms Thoracic Cancer

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

stereotactic body radiotherapy

Radiation

Treatment will take approximately 2 weeks.

Other names: SBRT

Research blood draw

Procedure

-Baseline, immediately after radiotherapy completion (fraction 5), 14 days after radiotherapy, and 30 day follow-up

Primary outcomes

  1. Rate of Local Control

    Time frame: At 6 months

  2. Number of Participants With Treatment-related, Non-hematologic Grade ≥ 3 Toxicity

    Time frame: Through 6 months

    -Graded using CTCAE v5.0

Secondary outcomes

  1. 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. 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

  3. 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

  4. 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.

  5. 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.

  6. 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

  7. 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

  8. 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

  9. 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

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • Goldman Sachs Foundation (Emerson Collective)

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
Sep 17, 2020
Registry last updated
Aug 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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