RECRUITING

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

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Conditions

Invasive Ductal Breast CarcinomaInvasive Ductal Breast Carcinoma Stage IVLobular Breast CarcinomaLobular Breast Carcinoma Stage IVNon Small Cell Lung CancerNSCLCGastrointestinal CancerGastrointestinal Squamous Cell CancerGastrointestinal AdenocarcinomaPancreatic CancerBladder CancerRenal Cell CarcinomaMelanomaSarcomaMetastatic Solid Tumorextra-cranial diseaselattice radiation therapyLRTspatially fractionated radiation therapySFRTSBRTstereotactic body radiation therapy22-207Memorial Sloan Kettering Cancer Center

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

A Pilot Study of Spatially Fractionated Radiation Therapy in Patients With Extra-Cranial Soft Tissue Metastases

Quick Facts

Study Start:2023-07-24
Study Completion:2026-07-24
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05837767

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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.
  2. * 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.
  3. * Age ≥ 18 years
  4. * ECOG Performance Status of 0 or 1.
  1. * Patients who are pregnant or breastfeeding
  2. * Prior radiation therapy to the candidate metastatic sites under consideration for treatment ("re-irradiation" is disallowed).
  3. * 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.
  4. * Patients with a "currently active" metastatic second malignancy.
  5. * 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.
  6. * 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.
  7. * Unwilling or unable to participate in all required study evaluations and procedures.
  8. * 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).

Contacts and Locations

Study Contact

Atif Khan, MD
CONTACT
848-225-6334
khana7@mskcc.org
Christopher Barker, MD
CONTACT
212-639-8168
barkerc@mskcc.org

Principal Investigator

Atif Khan, MD
PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center

Study Locations (Sites)

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, 07920
United States
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, 07748
United States
Memorial Sloan Kettering Bergen (Limited protocol activities)
Montvale, New Jersey, 07645
United States
Memorial Sloan Kettering Suffolk- Commack (Limited Protocol Activities)
Commack, New York, 11725
United States
Memorial Sloan Kettering Westchester (All Protocol Activities)
Harrison, New York, 10604
United States
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065
United States
Memorial Sloan Kettering Nassau (Limited protocol activities)
Rockville Centre, New York, 11553
United States

Collaborators and Investigators

Sponsor: Memorial Sloan Kettering Cancer Center

  • Atif Khan, MD, PRINCIPAL_INVESTIGATOR, Memorial Sloan Kettering Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-07-24
Study Completion Date2026-07-24

Study Record Updates

Study Start Date2023-07-24
Study Completion Date2026-07-24

Terms related to this study

Keywords Provided by Researchers

  • 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

Additional Relevant MeSH Terms

  • 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