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
Conditions
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
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).
Interventions
RADIATIONPalliative radiotherapy
Palliative radiotherapy (RT) will be performed using external beam ionizing radiation in accordance with standard practice
Sponsors
Memorial Sloan Kettering Cancer Center
Varian Medical Systems
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Response Rate (ORR) | 12 weeks from baseline | 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. |
Countries
United States
Contacts
CONTACTAtif Khan, MD
CONTACTChristopher Barker, MD
PRINCIPAL_INVESTIGATORAtif Khan, MD
Memorial Sloan Kettering Cancer Center
Outcome results
None listed