Trial Title:
A Study of Radiation Therapy to Treat Solid Tumor Cancer That Has Spread to Soft Tissue
NCT ID:
NCT05837767
Condition:
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: Official terms:
Carcinoma
Carcinoma, Non-Small-Cell Lung
Melanoma
Pancreatic Neoplasms
Sarcoma
Urinary Bladder Neoplasms
Carcinoma, Renal Cell
Breast Neoplasms
Gastrointestinal Neoplasms
Neoplasms, Squamous Cell
Carcinoma, Squamous Cell
Carcinoma, Ductal, Breast
Carcinoma, Lobular
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
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
Stereotactic body radiotherapy
Description:
The primary site requiring palliative radiotherapy will receive conventional SBRT dosing
of SBRT (or an alternate standard-of-care schedule).
Arm group label:
Participants with metastatic solid tumors
Other name:
SBRT
Intervention type:
Radiation
Intervention name:
Lattice Radiation Therapy
Description:
A second metastatic site (GTV volume at least 100 cc) will receive elective palliation
with a lattice RT pattern (LRT).
Arm group label:
Participants with metastatic solid tumors
Other name:
LRT
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).
Criteria for eligibility:
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).
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Address:
City:
Basking Ridge
Zip:
07920
Country:
United States
Status:
Recruiting
Contact:
Last name:
Atif Khan, MD
Phone:
848-225-6334
Facility:
Name:
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Address:
City:
Middletown
Zip:
07748
Country:
United States
Status:
Recruiting
Contact:
Last name:
Atif Khan, MD
Phone:
848-225-6334
Facility:
Name:
Memorial Sloan Kettering Bergen (Limited protocol activities)
Address:
City:
Montvale
Zip:
07645
Country:
United States
Status:
Recruiting
Contact:
Last name:
Atif Khan, MD
Phone:
848-225-6334
Facility:
Name:
Memorial Sloan Kettering Suffolk- Commack (Limited Protocol Activities)
Address:
City:
Commack
Zip:
11725
Country:
United States
Status:
Recruiting
Contact:
Last name:
Atif Khan, MD
Phone:
848-225-6334
Facility:
Name:
Memorial Sloan Kettering Westchester (All Protocol Activities)
Address:
City:
Harrison
Zip:
10604
Country:
United States
Status:
Recruiting
Contact:
Last name:
Atif Khan, MD
Phone:
848-225-6334
Facility:
Name:
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
Address:
City:
New York
Zip:
10065
Country:
United States
Status:
Recruiting
Contact:
Last name:
Atif Khan, MD
Phone:
848-225-6334
Facility:
Name:
Memorial Sloan Kettering Nassau (Limited protocol activities)
Address:
City:
Rockville Centre
Zip:
11553
Country:
United States
Status:
Recruiting
Contact:
Last name:
Atif Khan, MD
Phone:
848-225-6334
Start date:
July 24, 2023
Completion date:
July 24, 2026
Lead sponsor:
Agency:
Memorial Sloan Kettering Cancer Center
Agency class:
Other
Collaborator:
Agency:
Varian Medical Systems
Agency class:
Industry
Source:
Memorial Sloan Kettering Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05837767
http://www.mskcc.org
