Clinical Trials

Inclusion Criteria:

• Histologically proven primary or metastatic solid malignant tumors from any histologic subtype.

• Measurable primary or metastatic bulky tumor defined as tumor >5 cm in largest dimension not eligible for surgical resection or not an ideal candidate for alternative local therapies, e.g., cryoablation, etc.

• ECOG performance status 0-3 (Appendix I) assessed within 30 days of enrollment.

• Estimated life expectancy >3 months, as judged by treating clinician.

• Patients must sign IRB approved study specific informed consent.

• Patients must complete all required pre-entry tests listed in section 4.0 within the specified time limits.

• Patients must be able to start treatment (radiation) within 60 days of study registration.

• Patients must be at least 15 years old.

• A minimum most prominent symptom intensity score reported by the patient of >5 on an 11-point symptom intensity scale (item 4.3.2), clearly related to the target lesion, within one the following: Pain, dyspnea, hemorrhage, or dysphagia.

• Members of all races and ethnic groups are eligible for this trial.

• Patients from outside of the United States may participate in the study.

Exclusion Criteria:

• Prior RT to the current target site <3 months from randomization.

• Intracranial invasion by the proposed tumor target or tumor target intertwined with bowel loops.

• Concurrent systemic therapy (e.g., chemotherapy, immunotherapy) during or less than 2 weeks prior to RT delivery.

• Active rectal diverticulitis, Crohn’s disease affecting the rectum, or ulcerative colitis (non-active diverticulitis and Crohn’s disease not affecting the rectum are allowed), for patients whose target tumor is in the pelvis.

• Major medical, addictive, or psychiatric illness which in the investigator’s opinion, will prevent the consent process, completion of the treatment and/or interfere with follow-up. Consent by legal authorized representative is not permitted for this study.

• History of myocardial infarction or decompensated CHF within the last 6 months.

• On a transplant list.

• Any of the following are excluded because this study involves ionizing radiation

  • Pregnant persons

  • Nursing persons

  • Persons of childbearing potential who are unwilling to employ adequate birth control measures

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 03/23/2026. Questions regarding updates should be directed to the study team contact.