Palliative Spatially Fractionated (GRID) Radiotherapy Using Intensity Modulated Proton Therapy

NCT05831579 | Recruiting DMC FDA Device

• 1 other identifier: 202304011
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Spatially fractionated radiotherapy (SFRT or GRID) addresses some limitations of traditional stereotactic body radiation therapy by relying on beam collimation to create high-dose "peaks" and intervening low-dose "valleys" throughout the target volume. Standard palliative radiotherapy regimens provide limited durability of response, and there are challenges with delivery to large tumors or in previously irradiated fields. In this study, Proton GRID radiotherapy will be used to deliver three-fraction palliative radiotherapy to patients with tumors needing palliative radiation. The safety and efficacy of this approach will be assessed. It is hypothesized that GRID is highly effective, immunogenic, and associated with low rates of toxicity.

Conditions

Unresectable Solid Tumor; Metastatic Cancer

Keywords

proton; palliative radiotherapy; spatially fractionated radiotherapy; GRID; stereotactic body radiotherapy (SBRT); stereotactic ablative radiotherapy (SABR); cancer

Outcome Measures

Primary Outcomes (2)

• Rate of treatment-related acute toxicity

  -Grade per CTCAE v5.0.

  From start of treatment through 90 days

• Rate of treatment-related late toxicity

  -Grade per CTCAE v5.0.

  From day 91 through 12 months

Secondary Outcomes (3)

• Change in PRO-CTCAE (General Inventory and Disease Specific Inventory Assessment)

  Baseline, at last day of radiotherapy (day 3), within 2 weeks after completion of radiotherapy (day 14), 30 days, 90 days, 180 days, and 360 days

• Change in PROMIS Global Health

  Baseline, at last day of radiotherapy (day 3), within 2 weeks after completion of radiotherapy (day 14), 30 days, 90 days, 180 days, and 360 days

• Rate of target lesion local control

  3 months

Study Arms (2)

Cohort A: Reirradiation of Treatment Fields

EXPERIMENTAL

Radiotherapy will consist of 20 Gy proton GRID radiotherapy x 3 fractions.

Radiation: Proton GRID Radiotherapy

Cohort B: De Novo Radiation Treatment Fields

EXPERIMENTAL

Radiotherapy will consist of 20 Gy proton GRID radiotherapy x 3 fractions.

Radiation: Proton GRID Radiotherapy

Interventions

Proton GRID Radiotherapy RADIATION

The proton GRID radiotherapy prescription dose is 20 Gy x 3 fractions to the tumor, with an integrated dose of 6 Gy x 3 fractions to the PTV. Treatment to multiple lesions within the PTV is allowed (ex. a dominant lesion plus satellites). Multiple proton GRID radiotherapy plans may be delivered on the same day or different days, but they cannot overlap.

Cohort A: Reirradiation of Treatment Fields; Cohort B: De Novo Radiation Treatment Fields

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 diagnosis.
• Planning to undergo palliative radiotherapy to unresectable or metastatic target lesion ≥ 4.5 cm in any dimension as measured with radiographic imaging or with calipers by clinical exam.
• Cohort A: 10 patients with lesions that have been previously irradiated.
• Cohort B: 10 patients with lesions that have not been previously irradiated.
• ECOG performance status ≤ 3
• 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:

• Patients with tumors in need of urgent surgical intervention, such as life-threatening bleeding or those at high risk for pathologic fracture and amenable to surgical intervention.
• Patients with a superficial target lesion ≤ 1 cm deep to skin surface who initially had a superficial lesion irradiated, if the target lesion was in the area of the prior irradiation.
• Currently receiving any cytotoxic cancer therapy regimens or VEGF inhibitors that will overlap with the proton GRID 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.

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

RECRUITING

Related Links

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

MeSH Terms

Conditions

Neoplasm Metastasis; Neoplasms

Condition Hierarchy (Ancestors)

Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Anthony Apicelli, M.D.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anthony Apicelli, M.D.

CONTACT

314-362-8610; apicella@wustl.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2023
• First Posted: April 26, 2023
• Study Start: May 12, 2023
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: March 6, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 3 months after publication. No end date
• Access Criteria: Researchers who provide a methodologically sound proposal may be granted data access. Proposals should be directed to apicellia@wustl.edu. To gain access, data requestors will need to sign a data access agreement.

Locations

US (1)