This phase I trial tests the feasibility, safety, and side effects of proton GRID radiation therapy for the treatment of bulky tumors (>= 7 cm) in patients with invasive cancer. Bulky solid tumors are often difficult to treat because of their size as well as being closely located near other important organs. Bulky tumors also often respond poorly to radiation therapy. GRID-therapy, also called spatially-fractionated radiotherapy, involves delivering high dose radiation to small amounts of tumor in a manner that creates alternating regions of high and low dose radiation within the tumor and is often aligned in a grid pattern (so it is termed “GRID” therapy). A new approach to GRID-therapy has been developed using multi-beam proton pencil beam scanning (PBS), termed “PRO-GRID”. This study may help doctors assess the ability to generate technically deliverable PRO-GRID treatments, as well as side effects and the impact of the treatment on tumor size.
Additional locations may be listed on ClinicalTrials.gov for NCT05121545.
See trial information on ClinicalTrials.gov for a list of participating sites.
PRIMARY OBJECTIVE:
I. To assess the feasibility of a novel proton GRID therapy (proton pencil beam scanning spatially-fractionated radiotherapy [Pro-GRID]) for bulky solid tumors by successfully planning and delivering 10 of the first 12 patients.
SECONDARY OBJECTIVES:
I. To determine the rate of mild acute toxicity, defined as any Common Terminology Criteria for Adverse Events (CTCAE) version (v)4 grade 2 or lower toxicity, and severe acute toxicity, defined as any CTCAE v4 grade 3 or higher toxicity, from proton delivery up to 90 days after completion of Pro-GRID.
II. To determine the rate and degree of response for bulky tumors treated with proton GRID by Response Evaluation Criteria in Solid Tumors (RECIST) at 1, 6, and 12 months after completion of treatment.
OUTLINE:
Patients undergo pro-GRID radiation treatment over a single treatment session.
After completion of study treament, patients are followed up at 1, 3, 6, and 12 months.
Lead OrganizationJohns Hopkins University/Sidney Kimmel Cancer Center
Principal InvestigatorJean Lundberg Wright
