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

Study Purpose

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).

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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).

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05837767
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Memorial Sloan Kettering Cancer Center
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Atif Khan, MD
Principal Investigator Affiliation Memorial Sloan Kettering Cancer Center
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other, Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being 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
Study Website: View Trial Website
Arms & Interventions

Arms

Experimental: Participants with metastatic solid tumors

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

Interventions

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).

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Basking Ridge, New Jersey

Status

Recruiting

Address

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, 07920

Site Contact

Atif Khan, MD

[email protected]

848-225-6334

Middletown, New Jersey

Status

Recruiting

Address

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Middletown, New Jersey, 07748

Site Contact

Atif Khan, MD

[email protected]

848-225-6334

Montvale, New Jersey

Status

Recruiting

Address

Memorial Sloan Kettering Bergen (Limited protocol activities)

Montvale, New Jersey, 07645

Site Contact

Atif Khan, MD

[email protected]

848-225-6334

Commack, New York

Status

Recruiting

Address

Memorial Sloan Kettering Suffolk- Commack (Limited Protocol Activities)

Commack, New York, 11725

Site Contact

Atif Khan, MD

[email protected]

848-225-6334

Harrison, New York

Status

Recruiting

Address

Memorial Sloan Kettering Westchester (All Protocol Activities)

Harrison, New York, 10604

Site Contact

Atif Khan, MD

[email protected]

848-225-6334

New York, New York

Status

Recruiting

Address

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, 10065

Site Contact

Atif Khan, MD

[email protected]

848-225-6334

Rockville Centre, New York

Status

Recruiting

Address

Memorial Sloan Kettering Nassau (Limited protocol activities)

Rockville Centre, New York, 11553

Site Contact

Atif Khan, MD

[email protected]

848-225-6334

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