A Study of Radiation Therapy to Treat Solid Tumor Cancer That Has Spread to Soft Tissue

Study Overview
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Brief Summary
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The purpose of this study is to find out whether lattice radiation therapy (LRT) is an effective radiation therapy technique when compared to standard stereotactic body radiation therapy (SBRT). The study will also study how the different radiation therapy techniques (LRT and SBRT) affect how many immune cells are able to attack and kill tumor cells (immune infiltration).

Official Title
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A Pilot Study of Spatially Fractionated Radiation Therapy in Patients With Extra-Cranial Soft Tissue Metastases

Conditions
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Invasive Ductal Breast Carcinoma, Invasive Ductal Breast Carcinoma Stage IV, Lobular Breast Carcinoma, Lobular Breast Carcinoma Stage IV, Non Small Cell Lung Cancer, NSCLC, Gastrointestinal Cancer, Gastrointestinal Squamous Cell Cancer, Gastrointestinal Adenocarcinoma, Pancreatic Cancer, Bladder Cancer, Renal Cell Carcinoma, Melanoma, Sarcoma, Metastatic Solid Tumor

Intervention / Treatment
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* Radiation: Stereotactic body radiotherapy
* Radiation: Lattice Radiation Therapy


Participation Criteria
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Eligibility Criteria
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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 sarcoma, who require palliative radiation therapy to at least one site of extracranial metastastic disease. If a patient, requires palliative radiotherapy to additional sites, these can be treated with standard of care SBRT per departmental guidelines. Patients with at least one additional site of extracranial metastasis measuring at least 100 cc and suitable for elective palliative radiation therapy. Patients should be asymptomatic or minimally symptomatic (e.g controlled by oral pain medications) and not in urgent need for palliation to this site of elective treatment. Age ≥ 18 years 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 (re-irradiation is disallowed). Medical condition such as uncontrolled infection (including 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 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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Participants with metastatic solid tumors<br>Participants will have metastatic solid tumors and at least two sites of measurable extra-cranial disease | Radiation: Stereotactic body radiotherapy<br>* The primary site requiring palliative radiotherapy will receive conventional SBRT dosing of SBRT (or an alternate standard-of-care schedule).<br>* Other names: SBRT;Radiation: Lattice Radiation Therapy<br>* A second metastatic site (GTV volume at least 100 cc) will receive elective palliation with a lattice RT pattern (LRT).<br>* Other names: LRT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Response Rate (ORR) | The primary endpoint is ORR in the LRT-treated lesion, as defined by RECIST v.1.1 criteria, at 12 weeks on a standard-of-care response assessment CT or F-18-FDG PET/CT scan after LRT. | 12 weeks from baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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LRT, Invasive Ductal Breast Carcinoma, Lobular Breast Carcinoma, Non Small Cell Lung Cancer, NSCLC, Gastrointestinal Cancer, Gastrointestinal Squamous Cell Cancer, Pancreatic Cancer, Bladder Cancer, Renal Cell Carcinoma, Melanoma, Sarcoma, Metastatic Solid Tumor, extra-cranial disease, lattice radiation therapy, spatially fractionated radiation therapy, SFRT, SBRT, stereotactic body radiation therapy, 22-207, Memorial Sloan Kettering Cancer Center