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

Sarcoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04553471
• Other study ID #: 202009022
• Status: Completed
• Phase: N/A
• Start date: September 22, 2020
• Est. completion date: May 4, 2023

Study information

• Verified date: September 2023
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: May 4, 2023
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Abdominal Cancer
• Pelvic Cancer
• Pelvic Neoplasms
• Sarcoma
• Thoracic Cancer

Intervention

Radiation:
• Stereotactic body radiotherapy
Treatment will take approximately 2 weeks.

Procedure:
• Research blood draw
-Baseline, immediately after radiotherapy completion (fraction 5), 14 days after radiotherapy, and 30 day follow-up

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	Goldman Sachs Foundation (Emerson Collective)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of Local Control		At 6 months
Primary	Number of Participants With Treatment-related, Non-hematologic Grade = 3 Toxicity	-Graded using CTCAE v5.0	Through 6 months
Secondary	Patient Reported Toxicity as Measured by PRO-CTCAE Assessment	-The PRO-CTCAE Measurement System characterizes the frequency, severity, interference, and presence/absence of symptomatic toxicities	Baseline, 2 weeks post-treatment (approximately week 4), 30 days, 3 months, 6 months, and 12 months
Secondary	Quality of Life as Measured by PROMIS Physical Function Assessment	10-item questionnaire assessing current self-reported physical function; Answers range from 1-cannot do to 5=not at all/without any difficulty; Score ranges from 10-50 with a higher score indicating better physical function	Baseline, 2 weeks post-treatment (approximately week 4), 30 days, 3 months, 6 months, and 12 months
Secondary	Quality of Life as Measured by PROMIS Global Health Physical Assessment	2-item questionnaire assessing current self-reported overall physical function; Answers range from 1=poor/not all all to 5=excellent/completely; Score ranges from 2-10 with a higher score indicating better global health physical function	Baseline, 2 weeks post-treatment (approximately week 4), 30 days, 3 months, 6 months, and 12 months
Secondary	Quality of Life as Measured by PROMIS Anxiety Assessment	29-item questionnaire assessing current self-reported anxiety; Answers range from 1-never to 5=always; Score ranges from 29-145 with a lower score indicating less anxiety	Baseline, 2 weeks post-treatment (approximately week 4), 30 days, 3 months, 6 months, and 12 months
Secondary	Quality of Life as Measured by PROMIS Depression Assessment	4-item questionnaire assessing current self-reported depression; Answers range from 1=never to 5=always; Score ranges from 4-20 with a lower score indicating less depression	Baseline, 2 weeks post-treatment (approximately week 4), 30 days, 3 months, 6 months, and 12 months
Secondary	Patient Reported Pain as Measured by Numeric Pain Scale	-The Numeric Pain Scale is an 11-point scale for patient self-reporting of pain	Baseline, 2 weeks post-treatment (approximately week 4), 30 days, 3 months, 6 months, and 12 months

External Links

•   Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine