Comparing two radiation therapy techniques for advanced solid tumors
A Pilot Study of Spatially Fractionated Radiation Therapy in Patients With Extra-Cranial Soft Tissue Metastases
This study is testing whether a new type of radiation therapy works better than the standard method for treating advanced solid tumors that have spread, to see if it can improve outcomes for patients needing palliative care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 26 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Memorial Sloan Kettering Cancer Center Academic / other |
| Drugs / interventions | radiation |
| Locations | 7 sites (Basking Ridge, New Jersey and 6 other locations) |
| Trial ID | NCT05837767 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of lattice radiation therapy (LRT) compared to standard stereotactic body radiation therapy (SBRT) in treating advanced solid tumors that have spread to soft tissue. It will also investigate how these different radiation techniques influence the immune response against tumor cells, specifically looking at immune cell infiltration. Patients with biopsy-confirmed advanced metastatic solid tumors, including various types of breast cancer and non-small cell lung cancer, will be included in the study. The goal is to determine which radiation therapy method may provide better outcomes for patients requiring palliative care.
Who should consider this trial
Good fit: Ideal candidates are patients with biopsy-confirmed advanced or metastatic solid tumors requiring palliative radiation therapy.
Not a fit: Patients with early-stage cancers or those not requiring palliative radiation therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved radiation therapy techniques that enhance immune responses against tumors, potentially benefiting patients with advanced cancers.
How similar studies have performed: Other studies have shown promising results with innovative radiation therapy techniques, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Basking Ridge, New Jersey and 6 other locations
- Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) — Basking Ridge, New Jersey, United States (Recruiting)
- Memorial Sloan Kettering Monmouth (Limited Protocol Activities) — Middletown, New Jersey, United States (Recruiting)
- Memorial Sloan Kettering Bergen (Limited protocol activities) — Montvale, New Jersey, United States (Recruiting)
- Memorial Sloan Kettering Suffolk- Commack (Limited Protocol Activities) — Commack, New York, United States (Recruiting)
- Memorial Sloan Kettering Westchester (All Protocol Activities) — Harrison, New York, United States (Recruiting)
- Memorial Sloan Kettering Cancer Center (All Protocol Activities) — New York, New York, United States (Recruiting)
- Memorial Sloan Kettering Nassau (Limited protocol activities) — Rockville Centre, New York, United States (Recruiting)
Study contacts
- Principal investigator: Atif Khan, MD — Memorial Sloan Kettering Cancer Center
- Study coordinator: Atif Khan, MD
- Email: khana7@mskcc.org
- Phone: 848-225-6334
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.