A Study Of Radiation Therapy To Treat Solid Tumor Cancer That Has Spread To Soft Tissue

Study Overview

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

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).

N/A

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

RADIATION: Stereotactic body radiotherapy
RADIATION: Lattice Radiation Therapy

22-207

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2023-04-20	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2025-05-15
First Submitted that Met QC Criteria 2023-04-20	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2025-05-20
First Posted (ACTUAL) 2023-05-01	Results First Posted N/A	Last Verified 2025-05

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

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

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Participants with metastatic solid tumors

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

RADIATION: Stereotactic body radiotherapy

The primary site requiring palliative radiotherapy will receive conventional SBRT dosing of SBRT (or an alternate standard-of-care schedule).

RADIATION: Lattice Radiation Therapy

A second metastatic site (GTV volume at least 100 cc) will receive elective palliation with a lattice RT pattern (LRT).

Primary Outcome Measures	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

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Atif Khan, MD

Phone Number: 848-225-6334

Email: khana7@mskcc.org

Study Contact Backup

Name: Christopher Barker, MD

Phone Number: 212-639-8168

Email: barkerc@mskcc.org

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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.

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).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Varian Medical Systems

Investigators

PRINCIPAL_INVESTIGATOR: Atif Khan, MD, Memorial Sloan Kettering Cancer Center

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

Learn

Resources

PatientS

Caregivers

Clinical Trial Record