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RecruitingNCT07856394Updated Oct 7, 2026

Adding Spatially Fractionated Radiation Therapy to Standard Palliative Radiation for Improving Disease-Related Symptoms in Patients With Unresectable Solid Tumors

An interventional study of Electronic Health Record Review and External Beam Radiation Therapy in Metastatic Malignant Solid Neoplasm, Unresectable Malignant Solid Neoplasm and Unresectable Solid Tumor, sponsored by Mayo Clinic. Recruiting at 2 sites in United States. Open to participants aged 15 Years and older. Per ClinicalTrials.gov, last updated 2026-10-07.

Sponsored by Mayo Clinic · Not applicable, Interventional, and Treatment

Updated Oct 2, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
15 Years and older
Sex
All
01

Study summary

This clinical trial evaluates whether adding spatially fractionated radiation therapy (SFRT) to standard palliative external beam radiation therapy (EBRT) improves disease-related symptoms in patients with solid tumors that cannot be removed by surgery (unresectable). SFRT, originally termed GRID therapy, is a radiation therapy technique designed to deliver a highly uneven dose of radiation to a tumor. This is achieved by using a grid-like pattern, where isolated regions receive high doses, while the spaces between experience significantly lower doses. This method allows for a greater total dose to be delivered to the tumor while potentially reducing damage to surrounding healthy tissues. EBRT is a type of radiation therapy that uses a machine to aim high-energy rays at the cancer from outside of the body. Adding SFRT to standard palliative EBRT may improve disease-related symptoms such as pain, difficulty breathing, bleeding, or difficulty swallowing in patients with unresectable solid tumors.

02

Conditions studied

  • Metastatic Malignant Solid Neoplasm
  • Unresectable Malignant Solid Neoplasm
  • Unresectable Solid Tumor
  • Malignant Tumor
  • Metastatic Solid Tumor
03

In context

Neoplasm Metastasis

3,514 studies on the registry are indexed under Neoplasm Metastasis; 883 are open to participants now.

This study's planned enrollment of 100 is above the median of 54 across 2,765 interventional studies indexed under Neoplasm Metastasis.

Browse Neoplasm Metastasis studies →

Lead sponsor

Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 670 are open to participants now.

Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
15 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    Group I (SFRT, EBRT)

    Patients undergo a single fraction of SFRT. Starting 1-3 days after SFRT, patients undergo standard palliative EBRT in a dose regimen determined by the treating physician.

    Other: Electronic Health Record Review · Radiation: External Beam Radiation Therapy · Other: Questionnaire Administration · Radiation: Spatially-fractionated Radiation Therapy

  • Active comparator
    Group II (EBRT)

    Patients undergo standard palliative EBRT in a dose regimen determined by the treating physician.

    Other: Electronic Health Record Review · Radiation: External Beam Radiation Therapy · Other: Questionnaire Administration

Interventions

  • OtherElectronic Health Record Review

    Ancillary studies

  • RadiationExternal Beam Radiation Therapy

    Undergo standard palliative EBRT

    Also known as: Definitive Radiation Therapy, EBRT, External Beam Radiation, External Beam Radiotherapy, External Beam Radiotherapy (conventional), External Beam RT, external radiation, External Radiation Therapy, external-beam radiation, Radiation, External Beam, Teleradiotherapy, Teletherapy, Teletherapy Radiation

  • OtherQuestionnaire Administration

    Ancillary studies

  • RadiationSpatially-fractionated Radiation Therapy

    Undergo SFRT

    Also known as: GRID Therapy, SFRT, Spatially Fractionated Radiation Therapy

06

What researchers measure

Primary outcomes

  1. Response at 1 month - Patient-reported Impression of Change

    Participants rate the most prominent symptom related to the target lesion to be treated on a 7-point scale ranging from -3 (very much worse) to +3 (very much better). Response will be reported as a binary yes/no, defined as a patient reporting that the symptom is moderately better or very much better 1 month after completing treatment.

    Time frame: Baseline to 1 month follow-up

Secondary outcomes

  1. Change in Patient-reported Most Prominent Symptom Intensity

    Participants will record the severity of the most prominent symptom related to the target lesion (e.g., pain, dyspnea, hemorrhage, dysphagia) using an 11-point Likert scale ranging from 0 (none) to 10 (unbearable). A between-group comparison of the magnitude of the severity scores will be made.

    Time frame: Baseline to 1 month follow-up

  2. Response at 3 months - Patient-reported Impression of Change

    Participants rate the most prominent symptom related to the target lesion to be treated on a 7-point scale ranging from -3 (very much worse) to +3 (very much better). Response will be reported as a binary yes/no, defined as a patient reporting that the symptom is moderately better or very much better 3 months after completing treatment.

    Time frame: At 3 month follow-up

  3. Radiographic tumor response

    Radiographic tumor response at 3 months post-treatment will be assessed by a modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Radiographic tumor response will be coded as a 1 if the patient meets the complete response (CR) or partial response (PR) modified RECIST criteria and 0 otherwise. Per the modified RECIST criteria, CR will be defined as disappearance of the target lesion, PR will be defined as ≥30% decrease in longest diameter (LD) of target lesion as compared to baseline measurement, Progressive Disease (PD) will be defined as ≥20% increase in LD of target lesion as compared to baseline measurement, and Stable Disease (SD) will be defined as not meeting the criteria for CR, PR, or PD.

    Time frame: At 3 month follow-up

07

Study locations

1 of 2 sites recruiting
  • Mayo Clinic in Arizona
    Scottsdale, Arizona 85259, United States
    Recruiting
  • Mayo Clinic in Rochester
    Rochester, Minnesota 55905, United States
    Not yet recruiting
08

References and documents

09

Updates

2 registry updates since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 2, 2026
Show all 2 updates
  1. Oct 7, 2026
    Minor edits only
    + 3 other changes: index terms, verification date and conditions
  2. Oct 2, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07856394
Lead sponsor
Mayo Clinic
Responsible party
Sponsor
First posted
Oct 2, 2026
Start date
Sep 23, 2026
Primary completion
Sep 30, 2031 (estimated)
Completion
Sep 30, 2031 (estimated)
Last update
Oct 7, 2026

Study contacts

Clinical Trials Referral Office
Contact
mayocliniccancerstudies@mayo.edu
855-776-0015
Diego Augusto Santos Toesca, MD
principal investigator · Mayo Clinic

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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