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Recruiting NCT05837767

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

No phase Interventional Invasive Ductal Breast Carcinoma Invasive Ductal Breast Carcinoma Stage IV Lobular Breast Carcinoma Lobular Breast Carcinoma Stage IV

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Palliative radiotherapy.
Who it may be relevant to
Registry conditions: Invasive Ductal Breast Carcinoma, Invasive Ductal Breast Carcinoma Stage IV, Lobular Breast Carcinoma, Lobular Breast Carcinoma Stage IV. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

  • Radiation Palliative radiotherapy
    Palliative radiotherapy (RT) will be performed using external beam ionizing radiation in accordance with standard practice

Primary outcome measures

  • Overall Response Rate (ORR) [Time frame: 12 weeks from baseline]

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 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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 7 centers
  • Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) — Basking Ridge
  • Memorial Sloan Kettering Monmouth (Limited Protocol Activities) — Middletown
  • Memorial Sloan Kettering Bergen (Limited protocol activities) — Montvale
  • Memorial Sloan Kettering Suffolk- Commack (Limited Protocol Activities) — Commack
  • Memorial Sloan Kettering Westchester (All Protocol Activities) — Harrison
  • Memorial Sloan Kettering Cancer Center (All Protocol Activities) — New York
  • Memorial Sloan Kettering Nassau (Limited protocol activities) — Rockville Centre

Identifiers

NCT: NCT05837767 · 22-207

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗