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Lattice Radiation Therapy to Treat Solid Tumor Cancer That Has Spread to Soft Tissue
Trial Status: active
This clinical trial studies how well lattice radiation therapy (LRT) works in treating patients with a solid tumor cancer that has spread beyond its original location (metastatic) to soft tissue (such as muscle, fat, or blood vessels). Lattice radiation therapy (LRT) uses radiation to create a certain pattern of high dose radiation alternating with areas of lower dose, very similar to poking holes into a tumor. LRT may be as effective as standard of care radiation treatment in treating patients with solid tumors metastatic to soft tissue. This trial may also help researchers learn how the different radiation therapy techniques affect how many immune cells are able to attack and kill tumor cells (immune infiltration).
Inclusion Criteria
Patients with biopsy confirmed advanced/metastatic solid tumors of the following types: invasive ductal or lobular breast carcinoma (all histological and intrinsic subtypes), non-small cell lung cancer (NSCLC, all subtypes), gastrointestinal squamous cell or adenocarcinomas (including pancreatic cancer), bladder cancer, renal cell carcinoma, melanoma, and soft tissue sarcoma (all subtypes), who require and are being planned for palliative radiation therapy to at least one site of extracranial metastatic disease measuring at least 5 cm in a single axis. If a patient, requires palliative radiotherapy to additional sites, these can be treated with standard of care SBRT per departmental guidelines
Age >= 18 years
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Exclusion Criteria
Patients who are pregnant or breastfeeding
Prior radiation therapy to the candidate metastatic sites under consideration for treatment (“reirradiation” is disallowed)
Medical condition such as uncontrolled infection (including human immunodeficiency virus [HIV]), uncontrolled diabetes mellitus, or connective tissue diseases (lupus, systemic sclerosis, or other collagen vascular diseases) that, in the opinion of the treating physician, would make this protocol unreasonably hazardous for the patient
Patients with a "currently active" metastatic second malignancy
Patients on oral or parental corticosteroids. Physiological doses of steroids are permitted (eg for patients with adrenal insufficiency). If patients are on supraphysiological doses of steroids, these must be discontinued and held during the period of the study
Concomitant anti-neoplastic treatment is not allowed during the days of radiation treatment delivery and should be completed or held for 3 days prior to commencement of protocol treatment and for 3 days following completion of radiotherapy, or with resolution of associated acute toxicities
Unwilling or unable to participate in all required study evaluations and procedures
Unable to understand the purpose and risks of the study and to provide a signed and dated informed consent form (ICF) and authorization to use protected health information (in accordance with national and local patient privacy regulations)
Additional locations may be listed on ClinicalTrials.gov for NCT05837767.
I. To evaluate the overall response rate (complete response [CR] and partial response [PR]) at 8 weeks in the LRT-treated lesion on imaging using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).
II. To report differences in expression of predefined ribonucleic acid sequencing (RNA seq) signatures of immune-infiltration in research biopsies from LRT-treated lesions.
SECONDARY OBJECTIVES:
I. To descriptively report the complete response rate on RECIST v1.1 at 8 weeks in the LRT-treated lesion.
II. To descriptively report on the complete response rate at 8 weeks using Positron Emission Tomography Response Criteria in Solid Tumors (PERCIST) in the LRT-treated lesion, when available.
III. To correlate expression changes in RNA sequence signatures suggestive of immune-infiltration with tumor responses on RECIST and PERCIST.
IV. To descriptively report percent volume reduction in the LRT- and stereotactic body radiation therapy (SBRT)-treated lesions (in prior or future lesions treated as standard of care) at 8-12 weeks (when available).
V. To descriptively compare responses with SBRT and LRT treated lesions (when available).
VI. To descriptively report the rate and type of grade 3 or higher Common Terminology Criteria for Adverse Events (CTCAE) toxicities.
EXPLORATORY OBJECTIVE:
I. To report CD8+ T-cell repertoire diversification by high throughput sequencing of the TCRb CDR3 region using the ImmunoSEQ immune profiling system or single-cell ribonucleic acid (scRNA) sequencing from post-treatment tumor biopsies and from peripheral blood mononuclear cells (PBMCs) using standard kits.
OUTLINE:
Patients undergo 1 fraction of LRT to a single-metastatic site that is amendable to research biopsies. Patients may also undergo SBRT to up to 5 additional metastatic sites at the discretion of the treating physician. Patients undergo computed tomography (CT) or positron emission tomography (PET)/CT, blood sample collection and tissue biopsy during screening and while on study.
After completion of study treatment, patients are followed up at 2 and 8 weeks.
Trial PhaseNo phase specified
Trial Typetreatment
Lead OrganizationMemorial Sloan Kettering Cancer Center
