search
Back to results

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

Primary Purpose

Invasive Ductal Breast Carcinoma, Invasive Ductal Breast Carcinoma Stage IV, Lobular Breast Carcinoma

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Stereotactic body radiotherapy
Lattice Radiation Therapy
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Invasive Ductal Breast Carcinoma focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 sarcoma, who require palliative radiation therapy to at least one site of 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 extracranial metastasis measuring at least 100 cc 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 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 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).

Sites / Locations

  • Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)Recruiting
  • Memorial Sloan Kettering Monmouth (Limited Protocol Activities)Recruiting
  • Memorial Sloan Kettering Bergen (Limited protocol activities)Recruiting
  • Memorial Sloan Kettering Suffolk- Commack (Limited Protocol Activities)Recruiting
  • Memorial Sloan Kettering Westchester (All Protocol Activities)Recruiting
  • Memorial Sloan Kettering Cancer Center (All Protocol Activities)Recruiting
  • Memorial Sloan Kettering Nassau (Limited protocol activities)Recruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Participants with metastatic solid tumors

Arm Description

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

Outcomes

Primary Outcome Measures

Overall Response Rate (ORR)
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.

Secondary Outcome Measures

Full Information

First Posted
April 20, 2023
Last Updated
August 4, 2023
Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
Varian Medical Systems
search

1. Study Identification

Unique Protocol Identification Number
NCT05837767
Brief Title
A Study of Radiation Therapy to Treat Solid Tumor Cancer That Has Spread to Soft Tissue
Official Title
A Pilot Study of Spatially Fractionated Radiation Therapy in Patients With Extra-Cranial Soft Tissue Metastases
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 24, 2023 (Actual)
Primary Completion Date
July 24, 2026 (Anticipated)
Study Completion Date
July 24, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
Varian Medical Systems

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
26 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Participants with metastatic solid tumors
Arm Type
Experimental
Arm Description
Participants will have metastatic solid tumors and at least two sites of measurable extra-cranial disease
Intervention Type
Radiation
Intervention Name(s)
Stereotactic body radiotherapy
Other Intervention Name(s)
SBRT
Intervention Description
The primary site requiring palliative radiotherapy will receive conventional SBRT dosing of SBRT (or an alternate standard-of-care schedule).
Intervention Type
Radiation
Intervention Name(s)
Lattice Radiation Therapy
Other Intervention Name(s)
LRT
Intervention Description
A second metastatic site (GTV volume at least 100 cc) will receive elective palliation with a lattice RT pattern (LRT).
Primary Outcome Measure Information:
Title
Overall Response Rate (ORR)
Description
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.
Time Frame
12 weeks from baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 sarcoma, who require palliative radiation therapy to at least one site of 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 extracranial metastasis measuring at least 100 cc 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 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 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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Atif Khan, MD
Phone
848-225-6334
Email
khana7@mskcc.org
First Name & Middle Initial & Last Name or Official Title & Degree
Christopher Barker, MD
Phone
212-639-8168
Email
barkerc@mskcc.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Atif Khan, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
City
Basking Ridge
State/Province
New Jersey
ZIP/Postal Code
07920
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Atif Khan, MD
Phone
848-225-6334
Facility Name
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
City
Middletown
State/Province
New Jersey
ZIP/Postal Code
07748
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Atif Khan, MD
Phone
848-225-6334
Facility Name
Memorial Sloan Kettering Bergen (Limited protocol activities)
City
Montvale
State/Province
New Jersey
ZIP/Postal Code
07645
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Atif Khan, MD
Phone
848-225-6334
Facility Name
Memorial Sloan Kettering Suffolk- Commack (Limited Protocol Activities)
City
Commack
State/Province
New York
ZIP/Postal Code
11725
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Atif Khan, MD
Phone
848-225-6334
Facility Name
Memorial Sloan Kettering Westchester (All Protocol Activities)
City
Harrison
State/Province
New York
ZIP/Postal Code
10604
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Atif Khan, MD
Phone
848-225-6334
Facility Name
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Atif Khan, MD
Phone
848-225-6334
Facility Name
Memorial Sloan Kettering Nassau (Limited protocol activities)
City
Rockville Centre
State/Province
New York
ZIP/Postal Code
11553
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Atif Khan, MD
Phone
848-225-6334

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Links:
URL
http://www.mskcc.org
Description
Memorial Sloan Kettering Cancer Center

Learn more about this trial

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

We'll reach out to this number within 24 hrs