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

Not Applicable

Recruiting

• Conditions: Invasive Ductal Breast Carcinoma; Gastrointestinal Cancer; Lobular Breast Carcinoma; Gastrointestinal Squamous Cell Cancer; Metastatic Solid Tumor; Lobular Breast Carcinoma Stage IV; NSCLC; Gastrointestinal Adenocarcinoma; Bladder Cancer; Invasive Ductal Breast Carcinoma Stage IV
• Interventions: Radiation: Stereotactic body radiotherapy; Radiation: Lattice Radiation Therapy

• Registration Number: NCT05837767
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-04-20
• Study First Submitted QC: 2023-04-20
• Study First Posted: 2023-05-01
• Study Start: 2023-07-24
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-15
• Last Update Posted: 2025-05-20
• Primary Completion: 2026-07-24
• Study Completion: 2026-07-24

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 26

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 RECIST-measurable 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 RECIST-measurable extracranial metastasis measuring at least 4 cm in one axis 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 experimental 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. 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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Participants with metastatic solid tumors	Stereotactic body radiotherapy	Participants will have metastatic solid tumors and at least two sites of measurable extra-cranial disease
Participants with metastatic solid tumors	Lattice Radiation Therapy	Participants will have metastatic solid tumors and at least two sites of measurable extra-cranial disease

Primary Outcome Measures

Name	Time	Method
Overall Response Rate (ORR)	12 weeks from baseline	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.

Trial Locations

Locations (7)

Memorial Sloan Kettering Cancer Center (All Protocol Activities); 🇺🇸 New York, New York, United States

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities); 🇺🇸 Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Nassau (Limited protocol activities); 🇺🇸 Rockville Centre, New York, United States

Memorial Sloan Kettering Westchester (All Protocol Activities); 🇺🇸 Harrison, New York, United States

Memorial Sloan Kettering Suffolk- Commack (Limited Protocol Activities); 🇺🇸 Commack, New York, United States

Memorial Sloan Kettering Monmouth (Limited Protocol Activities); 🇺🇸 Middletown, New Jersey, United States

Memorial Sloan Kettering Bergen (Limited protocol activities); 🇺🇸 Montvale, New Jersey, United States