Dysautonomia International

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

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).

Conditions

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

Eligibility

Eligible Ages: Over 18 Years
Eligible Sex: 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

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

Phase: N/A
Study Type: Interventional
Allocation: N/A
Intervention Model: Single Group Assignment
Primary Purpose: Treatment
Masking: None (Open Label)

Arm Groups

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

Recruiting Locations

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey 07920