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

NCT ID: NCT05837767

Last Updated: 2025-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-24

Study Completion Date

2026-07-24

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).

Detailed Description

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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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Participants with metastatic solid tumors

Participants will have metastatic solid tumors and at least two sites of measurable extra-cranial disease

Group Type EXPERIMENTAL

Palliative radiotherapy

Intervention Type RADIATION

Palliative radiotherapy (RT) will be performed using external beam ionizing radiation in accordance with standard practice

Interventions

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Palliative radiotherapy

Palliative radiotherapy (RT) will be performed using external beam ionizing radiation in accordance with standard practice

Intervention Type RADIATION

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 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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Varian Medical Systems

INDUSTRY

Sponsor Role collaborator

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Atif Khan, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

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Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, United States

Site Status RECRUITING

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Middletown, New Jersey, United States

Site Status RECRUITING

Memorial Sloan Kettering Bergen (Limited protocol activities)

Montvale, New Jersey, United States

Site Status RECRUITING

Memorial Sloan Kettering Suffolk- Commack (Limited Protocol Activities)

Commack, New York, United States

Site Status RECRUITING

Memorial Sloan Kettering Westchester (All Protocol Activities)

Harrison, New York, United States

Site Status RECRUITING

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, United States

Site Status RECRUITING

Memorial Sloan Kettering Nassau (Limited protocol activities)

Rockville Centre, New York, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Atif Khan, MD

Role: CONTACT

848-225-6334

Christopher Barker, MD

Role: CONTACT

212-639-8168

Facility Contacts

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Atif Khan, MD

Role: primary

848-225-6334

Atif Khan, MD

Role: primary

848-225-6334

Atif Khan, MD

Role: primary

848-225-6334

Atif Khan, MD

Role: primary

848-225-6334

Atif Khan, MD

Role: primary

848-225-6334

Atif Khan, MD

Role: primary

848-225-6334

Atif Khan, MD

Role: primary

848-225-6334

Related Links

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http://www.mskcc.org

Memorial Sloan Kettering Cancer Center

Other Identifiers

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22-207

Identifier Type: -

Identifier Source: org_study_id

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