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A Study of Radiation Therapy to Treat Solid Tumor Cancer That Has Spread to Soft Tissue
NCT05837767 · Memorial Sloan Kettering Cancer Center
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
A Pilot Study of Spatially Fractionated Radiation Therapy in Patients With Extra-Cranial Soft Tissue Metastases
About this study
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).
Eligibility criteria
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
* 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. 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).
Study design
Enrollment target: 26 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2023-07-24
Estimated completion: 2026-07-24
Last updated: 2026-03-30
Interventions
Radiation: Palliative radiotherapy
Primary outcomes
- • Overall Response Rate (ORR) (12 weeks from baseline)
Sponsor
Memorial Sloan Kettering Cancer Center · other
With: Varian Medical Systems
Contacts & investigators
ContactAtif Khan, MD · contact · khana7@mskcc.org · 848-225-6334
ContactChristopher Barker, MD · contact · barkerc@mskcc.org · 212-639-8168
InvestigatorAtif Khan, MD · principal_investigator, Memorial Sloan Kettering Cancer Center
All locations (7)
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)Recruiting
Basking Ridge, New Jersey, United States
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)Recruiting
Middletown, New Jersey, United States
Memorial Sloan Kettering Bergen (Limited protocol activities)Recruiting
Montvale, New Jersey, United States
Memorial Sloan Kettering Suffolk- Commack (Limited Protocol Activities)Recruiting
Commack, New York, United States
Memorial Sloan Kettering Westchester (All Protocol Activities)Recruiting
Harrison, New York, United States
Memorial Sloan Kettering Cancer Center (All Protocol Activities)Recruiting
New York, New York, United States
Memorial Sloan Kettering Nassau (Limited protocol activities)Recruiting
Rockville Centre, New York, United States