Thinking of joining a study?

Register your interest

Become a volunteer?

NCT05837767 | RECRUITING | Invasive Ductal Breast Carcinoma

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

Memorial Sloan Kettering Cancer Center

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).

Condition or disease

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

Intervention/treatment

Palliative radiotherapy

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 26 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : A Pilot Study of Spatially Fractionated Radiation Therapy in Patients With Extra-Cranial Soft Tissue Metastases
Actual Study Start Date : 2023-07-24
Estimated Primary Completion Date : 2026-07-24
Estimated Study Completion Date : 2026-07-24

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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 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).
A Study of Radiation Therapy to Treat Solid Tumor Cancer That Has Spread to Soft Tissue

Location Details

NCT05837767

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, New Jersey

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, United States, 07920

RECRUITING

United States, New Jersey

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Middletown, New Jersey, United States, 07748

RECRUITING

United States, New Jersey

Memorial Sloan Kettering Bergen (Limited protocol activities)

Montvale, New Jersey, United States, 07645

RECRUITING

United States, New York

Memorial Sloan Kettering Suffolk- Commack (Limited Protocol Activities)

Commack, New York, United States, 11725

RECRUITING

United States, New York

Memorial Sloan Kettering Westchester (All Protocol Activities)

Harrison, New York, United States, 10604

RECRUITING

United States, New York

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, United States, 10065

RECRUITING

United States, New York

Memorial Sloan Kettering Nassau (Limited protocol activities)

Rockville Centre, New York, United States, 11553