Metastatic Malignant Solid NeoplasmNCT07856394
Adding Spatially Fractionated Radiation Therapy to Standard Palliative Radiation for Improving Disease-Related Symptoms in Patients With Unresectable Solid Tumors
A study testing Electronic Health Record Review, External Beam Radiation Therapy and Questionnaire Administration in people with Metastatic Malignant Solid Neoplasm and Unresectable Malignant Solid Neoplasm, run by Mayo Clinic at 2 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Metastatic Malignant Solid Neoplasm, Unresectable Malignant Solid Neoplasm, Unresectable Solid Tumor
- What is being tested?
- Electronic Health Record Review, External Beam Radiation Therapy and Questionnaire Administration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesUnited States
- Study dates
- 23 Sep 2026to 30 Sep 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Clinical Trials Referral Office, 855-776-0015, mayocliniccancerstudies@mayo.edu
Meng X. Welliver, MD, PhD
- Recruiting
Mayo Clinic in Arizona
Scottsdale, Arizona, 85259
Clinical Trials Referral Office, 855-776-0015, mayocliniccancerstudies@mayo.edu
Diego A. Santos Toesca, MD
About this study
Official title: Multicenter, Randomized Phase II Trial on Palliative Radiation With or Without Spatially Fractionated Radiotherapy Boost for Unresectable Bulky Malignancies
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.
- Conditions
- Metastatic Malignant Solid Neoplasm, Unresectable Malignant Solid Neoplasm, Unresectable Solid Tumor, Malignant Tumor, Metastatic Solid Tumor
- Being tested
- Electronic Health Record Review, External Beam Radiation Therapy, Questionnaire Administration, Spatially-fractionated Radiation Therapy
- Medical subject headings
- Neoplasm Metastasis, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electronic Health Record ReviewOther
Ancillary studies
External Beam Radiation TherapyRadiation
Also called Definitive Radiation Therapy, EBRT, External Beam Radiation, External Beam Radiotherapy
Undergo standard palliative EBRT
Questionnaire AdministrationOther
Ancillary studies
Spatially-fractionated Radiation TherapyRadiation
Also called GRID Therapy, SFRT, Spatially Fractionated Radiation Therapy
Undergo SFRT
| Study group | Role | What they receive |
|---|---|---|
| Group I (SFRT, EBRT) | Experimental | 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. Receives: Other: Electronic Health Record Review; Radiation: External Beam Radiation Therapy; Other: Questionnaire Administration; Radiation: Spatially-fractionated Radiation Therapy |
| Group II (EBRT) | Active comparator | Patients undergo standard palliative EBRT in a dose regimen determined by the treating physician. Receives: Other: Electronic Health Record Review; Radiation: External Beam Radiation Therapy; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 1 month follow-up
Secondary outcomes (3)
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.
Measured: Baseline to 1 month follow-up
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.
Measured: At 3 month follow-up
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.
Measured: At 3 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2026
- Study start23 Sep 2026
- Primary completion30 Sep 2031 (estimated)
- Study completion30 Sep 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Malignant Solid NeoplasmStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Diego Augusto Santos Toesca, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07856394
- Sponsor's protocol ID
- GMROA2481
- Other IDs
- NCI-2026-06455, 25-005298
- Status last verified
- Oct 2026
- First submitted
- 23 Sep 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Randomized Phase II Trial on Palliative Radiation With or Without Spatially Fractionated Radiotherapy Boost for Unresectable Bulky Malignancies
- ClinicalTrials.gov ID
- NCT07856394
- Acronym / sponsor ID
- GMROA2481
- Conditions
- Metastatic Malignant Solid Neoplasm, Unresectable Malignant Solid Neoplasm, Unresectable Solid Tumor, Malignant Tumor, Metastatic Solid Tumor
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 23 Sep 2026 (actual)
- Primary completion
- 30 Sep 2031 (estimated)
- Study completion
- 30 Sep 2031 (estimated)
- First posted
- 2 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I (SFRT, EBRT) | Experimental | Other: Electronic Health Record Review, Radiation: External Beam Radiation Therapy, Other: Questionnaire Administration, Radiation: Spatially-fractionated Radiation TherapyPatients 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. |
| Group II (EBRT) | Active comparator | Other: Electronic Health Record Review, Radiation: External Beam Radiation Therapy, Other: Questionnaire AdministrationPatients undergo standard palliative EBRT in a dose regimen determined by the treating physician. |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electronic Health Record ReviewAncillary studies | Other | Group I (SFRT, EBRT), Group II (EBRT) |
| External Beam Radiation TherapyAlso: Definitive Radiation Therapy, EBRT, External Beam Radiation, External Beam RadiotherapyUndergo standard palliative EBRT | Radiation | Group I (SFRT, EBRT), Group II (EBRT) |
| Questionnaire AdministrationAncillary studies | Other | Group I (SFRT, EBRT), Group II (EBRT) |
| Spatially-fractionated Radiation TherapyAlso: GRID Therapy, SFRT, Spatially Fractionated Radiation TherapyUndergo SFRT | Radiation | Group I (SFRT, EBRT) |
Primary outcome
Response at 1 month - Patient-reported Impression of Change
Time frame: Baseline to 1 month follow-up
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.
3 secondary outcomes
Change in Patient-reported Most Prominent Symptom Intensity
Time frame: Baseline to 1 month follow-up
Response at 3 months - Patient-reported Impression of Change
Time frame: At 3 month follow-up
Radiographic tumor response
Time frame: At 3 month follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Diego Augusto Santos Toesca, MD principal investigator
Mayo Clinic
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electronic Health Record Review, External Beam Radiation Therapy and Questionnaire Administration in people with Metastatic Malignant Solid Neoplasm and Unresectable Malignant Solid Neoplasm, run by Mayo Clinic at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trials Referral Office (855-776-0015, mayocliniccancerstudies@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response at 1 month - Patient-reported Impression of Change (time frame: Baseline to 1 month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.