Recruiting

Radiation Therapy

Sponsor:

Memorial Sloan Kettering Cancer Center

Code:

NCT05837767

Conditions

Invasive Ductal Breast Carcinoma

Invasive Ductal Breast Carcinoma Stage IV

Lobular Breast Carcinoma

Lobular Breast Carcinoma Stage IV

Non Small Cell Lung Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Palliative radiotherapy

Study Details

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).

Conditions

Invasive Ductal Breast Carcinoma

Invasive Ductal Breast Carcinoma Stage IV

Lobular Breast Carcinoma

Lobular Breast Carcinoma Stage IV

Non Small Cell Lung Cancer

Study ID

NCT05837767

Start date

Jul 24, 2023

Status verified date

Sep, 2026

Completion date

Jul 24, 2027

Anticipated

Primary completion date

Jul 24, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

26 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Participants with metastatic solid tumors

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

Interventions

Palliative radiotherapy

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

Primary outcome measure

  • Overall Response Rate (ORR) [ Time Frame: 12 weeks from baseline ]

Central Contacts and Locations

Central contacts

Locations

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

Recruiting

Basking Ridge, New Jersey, United States, 07920

Contacts

Atif Khan, MD

848-225-6334

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Recruiting

Middletown, New Jersey, United States, 07748

Contacts

Atif Khan, MD

848-225-6334

Memorial Sloan Kettering Bergen (Limited protocol activities)

Recruiting

Montvale, New Jersey, United States, 07645

Contacts

Atif Khan, MD

848-225-6334

Memorial Sloan Kettering Suffolk- Commack (Limited Protocol Activities)

Recruiting

Commack, New York, United States, 11725

Contacts

Atif Khan, MD

848-225-6334

Memorial Sloan Kettering Westchester (All Protocol Activities)

Recruiting

Harrison, New York, United States, 10604

Contacts

Atif Khan, MD

848-225-6334

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

Recruiting

New York, New York, United States, 10065

Contacts

Atif Khan, MD

848-225-6334

Memorial Sloan Kettering Nassau (Limited protocol activities)

Recruiting

Rockville Centre, New York, United States, 11553

Contacts

Atif Khan, MD

848-225-6334

More Information

Sponsor

Memorial Sloan Kettering Cancer Center

Last update posted

Sep 2, 2026

Last verified

Sep, 2026

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center on 2026-09-02.