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

NCT04553471 | Completed Results DMC FDA Device

• 1 other identifier: 202009022
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sarcoma; Thoracic Cancer; Abdominal Cancer; Pelvic Cancer

Outcome Measures

Primary Outcomes (2)

• Rate of Local Control

  At 6 months

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

  -Graded using CTCAE v5.0

  Through 6 months

Secondary Outcomes (9)

• Mean Change From Baseline - PROMIS Physical Function Assessment

  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

  2 weeks post-treatment (approximately week 4), 30 days, 3 months, 6 months, and 12 months

• Mean Change From Baseline-PROMIS Depression Assessment

  2 weeks post-treatment (approximately week 4), 30 days, 3 months, 6 months, and 12 months

• Mean Change From Baseline-PROMIS Anxiety Assessment

  2 weeks post-treatment (approximately week 4), 30 days, 3 months, 6 months, and 12 months

• Mean Change From Baseline-Numeric Pain Scale

  2 weeks post-treatment (approximately week 4), 30 days, 3 months, 6 months, and 12 months

Study Arms (1)

SBRT

EXPERIMENTAL

5-fraction Lattice SBRT delivered to 20 Gy with a simultaneous integrated boost (SIB) to 66.7 Gy.

Radiation: Stereotactic body radiotherapy; Procedure: Research blood draw

Interventions

Stereotactic body radiotherapy RADIATION

Treatment will take approximately 2 weeks.

Also known as: SBRT

SBRT

Research blood draw PROCEDURE

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

SBRT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Washington University School of Medicine: lead
• Goldman Sachs Foundation (Emerson Collective): collaborator

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Publications (1)

• 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.

  PMID: 34195486 DERIVED

Related Links

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

MeSH Terms

Conditions

Sarcoma; Pelvic Neoplasms

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Results Point of Contact

• Title: Pamela Samson, M.D.
• Organization: Washington University School of Medicine

psamson@wustl.edu

314-747-1786

Study Officials

• Pamela Samson, M.D.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: At least 10 participants will be enrolled in each cohort (soft tissue sarcomas, thoracic cancers, abdominal, and pelvic cancers).

Study Record Dates

• First Submitted: September 9, 2020
• First Posted: September 17, 2020
• Study Start: September 22, 2020
• Primary Completion: September 30, 2022
• Study Completion: May 4, 2023
• Last Updated: August 29, 2024
• Results First Posted: October 12, 2023

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)