Metastatic Malignant Solid Neoplasm, Unresectable Malignant Solid Neoplasm, Unresectable Solid Tumor, Malignant Tumor, Metastatic Solid Tumor
Conditions
Brief 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.
Interventions
OTHERElectronic Health Record Review
Ancillary studies
RADIATIONExternal Beam Radiation Therapy
Undergo standard palliative EBRT
OTHERQuestionnaire Administration
Ancillary studies
Undergo SFRT
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
15 Years to No maximum
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
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Response at 1 month - Patient-reported Impression of Change | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Radiographic tumor response | At 3 month follow-up | 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. |
| Change in Patient-reported Most Prominent Symptom Intensity | Baseline to 1 month follow-up | 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. |
| Response at 3 months - Patient-reported Impression of Change | At 3 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 3 months after completing treatment. |
Countries
United States
Contacts
CONTACTClinical Trials Referral Office
PRINCIPAL_INVESTIGATORDiego Augusto Santos Toesca, MD
Mayo Clinic
Outcome results
None listed