Palliative Lattice Stereotactic Body Radiotherapy (SBRT)

NCT04133415 | Completed Results DMC FDA Device

• 1 other identifier: 201910071
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Standard palliative radiotherapy regimens may provide limited durability of response in large tumors. Thus, there is a clinical need for a new approach. The Lattice SBRT approach will deliver 20 Gy in 5 fractions with partial volume simultaneous integrated boosts to 66.7 Gy. This is hypothesized to improve symptom response, local control, and better prime the tumor microenvironment for immune response compared with standard palliative radiotherapy doses. It is also hypothesized that this will be associated with less toxicity than the traditional homogenous SBRT plan delivered to a large tumor. Blood will be collected before and after Lattice SBRT for evaluation of the peripheral blood immune microenvironment.

Conditions

Cancer; Palliative Radiotherapy

Outcome Measures

Primary Outcomes (1)

• Percentage of Patients With Treatment-related, Non-hematologic, Grade 3 or Higher Adverse Events

  -Measured by CTCAE version 5.0

  Through 90 days following completion of radiotherapy (estimated to be 90 days and 2 weeks)

Study Arms (1)

Lattice stereotactic body radiation therapy

EXPERIMENTAL

-Lattice SBRT prescribed to a dose of 20 Gy in 5 fractions with a simultaneous integrated boosts of 66.7 Gy in 5 fractions

Radiation: Lattice stereotactic body radiation therapy; Procedure: Peripheral blood

Interventions

Lattice stereotactic body radiation therapy RADIATION

-As long as radiotherapy fields do not overlap, treatment of up to 4 other tumor sites are allowed

Also known as: Lattice SBRT

Lattice stereotactic body radiation therapy

Peripheral blood PROCEDURE

-Before treatment, immediately after radiotherapy completion, 14 days after radiotherapy, and 30 days after radiotherapy

Lattice stereotactic body radiation therapy

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 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 (or that of legally authorized representative, if applicable).

You may not qualify if:

• Prior radiotherapy that overlaps with any planned site of protocol radiotherapy.
• 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 and/or breastfeeding. Women of childbearing potential must have a negative pregnancy test within 20 days of study entry.

Sponsors & Collaborators

• Washington University School of Medicine: lead

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

Neoplasms

Results Point of Contact

• Title: Matthew Spraker, M.D., Ph.D.
• Organization: Washington University School of Medicine

mspraker@wustl.edu

314-362-8567

Study Officials

• Matthew Spraker, M.D., Ph.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

Study Record Dates

• First Submitted: October 17, 2019
• First Posted: October 21, 2019
• Study Start: October 31, 2019
• Primary Completion: December 14, 2020
• Study Completion: December 14, 2020
• Last Updated: November 22, 2021
• Results First Posted: November 22, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)