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RecruitingNCT05837767Updated Sep 2, 2026

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

An interventional study of Palliative radiotherapy in Invasive Ductal Breast Carcinoma, Invasive Ductal Breast Carcinoma Stage IV and Lobular Breast Carcinoma, sponsored by Memorial Sloan Kettering Cancer Center. Recruiting at 7 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-02.

Sponsored by Memorial Sloan Kettering Cancer Center · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
26
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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).

02

Conditions studied

  • 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

Keywords

  • 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
  • LRT
  • spatially fractionated radiation therapy
  • SFRT
  • SBRT
  • stereotactic body radiation therapy
  • 22-207
  • Memorial Sloan Kettering Cancer Center
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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).
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
26 participants (estimated)

Study arms

  • Experimental
    Participants with metastatic solid tumors

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

    Radiation: Palliative radiotherapy

Interventions

  • RadiationPalliative radiotherapy

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

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 12 weeks from baseline

06

Study locations

7 of 7 sites recruiting
  • Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
    Basking Ridge, New Jersey 07920, United States
    • Atif Khan, MD · Contact · 848-225-6334
    Recruiting
  • Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
    Middletown, New Jersey 07748, United States
    • Atif Khan, MD · Contact · 848-225-6334
    Recruiting
  • Memorial Sloan Kettering Bergen (Limited protocol activities)
    Montvale, New Jersey 07645, United States
    • Atif Khan, MD · Contact · 848-225-6334
    Recruiting
  • Memorial Sloan Kettering Suffolk- Commack (Limited Protocol Activities)
    Commack, New York 11725, United States
    • Atif Khan, MD · Contact · 848-225-6334
    Recruiting
  • Memorial Sloan Kettering Westchester (All Protocol Activities)
    Harrison, New York 10604, United States
    • Atif Khan, MD · Contact · 848-225-6334
    Recruiting
  • Memorial Sloan Kettering Cancer Center (All Protocol Activities)
    New York, New York 10065, United States
    • Atif Khan, MD · Contact · 848-225-6334
    Recruiting
  • Memorial Sloan Kettering Nassau (Limited protocol activities)
    Rockville Centre, New York 11553, United States
    • Atif Khan, MD · Contact · 848-225-6334
    Recruiting
07

References and documents

Individual participant data

Plan to share: Yes — Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

08

Registry details

Key details

Study ID
NCT05837767
Lead sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
Varian Medical Systems
Responsible party
Sponsor
First posted
May 1, 2023
Start date
Jul 24, 2023
Primary completion
Jul 24, 2027 (estimated)
Completion
Jul 24, 2027 (estimated)
Last update
Sep 2, 2026

Study contacts

Atif Khan, MD
Contact
khana7@mskcc.org
848-225-6334
Christopher Barker, MD
Contact
barkerc@mskcc.org
212-639-8168
Atif Khan, MD
principal investigator · Memorial Sloan Kettering Cancer Center

Oversight

FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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