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

Launched by MEMORIAL SLOAN KETTERING CANCER CENTER · Apr 20, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating a new type of radiation therapy called lattice radiation therapy (LRT) to see if it works better than the standard approach known as stereotactic body radiation therapy (SBRT) for treating solid tumors that have spread to soft tissues. The study aims to understand how these different radiation techniques affect the immune system's ability to target and destroy cancer cells. If you have advanced or metastatic cancers such as certain types of breast cancer, lung cancer, gastrointestinal cancers, bladder cancer, or melanoma, you might be eligible to participate.

To join the trial, participants need to be at least 18 years old and have a confirmed diagnosis of one of the specified cancer types, requiring palliative radiation therapy for at least one measurable area of cancer spread. Participants should be in relatively good health and not have urgent medical needs that would prevent them from joining. Those who take certain medications or have specific medical conditions may not be eligible. If you enroll, you can expect to receive either LRT or SBRT as part of your treatment, and the study will closely monitor your health and responses to the therapy. It's important to note that this trial is currently recruiting participants, so if you're interested, please discuss this option with your doctor.

Gender

ALL

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).