Adding targeted GRID-style radiation to standard palliative therapy for unresectable solid tumors
Official title: Multicenter, Randomized Phase II Trial on Palliative Radiation With or Without Spatially Fractionated Radiotherapy Boost for Unresectable Bulky Malignancies
Run by Mayo Clinic · NCT07856394 · Data updated 2026-11-12
This study tests whether adding spatially fractionated radiation therapy to standard palliative radiation helps relieve symptoms in patients with unresectable solid tumors.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 15 Years and up |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Mayo Clinic Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy, radiation |
| Locations | 2 sites (Scottsdale, Arizona and 1 other locations) |
| Status | Recruiting |
| Started | September 23, 2026 |
| Main results expected | September 30, 2031 |
| Study ends | September 30, 2031 |
| Registry record updated | October 26, 2026 |
| Trial ID | NCT07856394 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults or adolescents (15+) with bulky, unresectable solid tumors, ECOG 0-3, life expectancy over 3 months, and a high symptom burden related to the target lesion.
✕Probably not a fit
Patients with very limited life expectancy, poor performance status (ECOG 4), or tumors unlikely to respond to radiotherapy may not obtain symptom benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional study evaluates whether combining spatially fractionated radiation therapy (SFRT), previously called GRID therapy, with standard external beam radiation therapy (EBRT) improves disease-related symptoms in patients with unresectable solid tumors. SFRT delivers a highly uneven radiation pattern to boost total tumor dose while aiming to spare surrounding healthy tissue. Participants receive SFRT alongside conventional palliative EBRT and complete assessments to gauge symptom changes and safety. Eligible patients have bulky measurable tumors, adequate performance status, and a reasonable life expectancy, and must begin treatment within 60 days of enrollment. The trial is led by Mayo Clinic with sites in Arizona and Minnesota.
Why it matters
Potential benefit: If successful, patients may experience greater symptom relief and potentially better local control with a treatment approach that tolerates higher tumor doses.
How similar studies have gone: Similar approaches with SFRT have shown potential in enhancing local effects while limiting toxicity in some tumor types, but definitive benefits require further study.
Who can join: the full rules
Show full inclusion / exclusion criteria
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. * Eastern Cooperative Oncology Group (ECOG) performance status 0-3 assessed within 30 days of enrollment * Estimated life expectancy \> 3 months, as judged by treating clinician * Patients must sign Institutional Review Board (IRB) approved study specific informed consent * Patients must complete all required pre-entry tests 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 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 RT delivery will not be an exclusion condition * 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 congestive heart failure (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 will be asked to stay on adequate forms of birth control until study intervention (therapy) is finished
Where it's running
-
Mayo Clinic in Arizona
Scottsdale, Arizona, United States Recruiting -
Mayo Clinic in Rochester
Rochester, Minnesota, United States Recruiting
Study contacts
- Principal investigator: Diego Augusto Santos Toesca, MD — Mayo Clinic
- Study coordinator: Clinical Trials Referral Office
- Email: mayocliniccancerstudies@mayo.edu
- Phone: 855-776-0015
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.