Cancer (Advanced Stage), Cancer (Solid Tumors), Tumor
Conditions
Keywords
SBRT, LATTICE, partial irradiation, large volume tumors
Brief summary
To assess the importance of using SBRT-LATTICE-PATHY for the radiotherapy treatment of large tumors that would be considered intractable by currently used standard techniques. In this present study, the investigators will have the possibility of combining SBRT and LATTICE techniques, incorporating the concept of hypoxic tissue irradiation, which are potential modulators of abscopal and bystander effects, performing partial punctual treatment in the vertex region, without the need for irradiation of the entire tissue volume, further improving safety in relation to possible toxicities.
Interventions
RADIATIONSBRT-LATTICE-PATHY
SBRT-LATTICE-PATHY, a single dose of 24Gy in intratumoral vertices located in hypoxic regions.
Sponsors
University of Sao Paulo General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* age =or\> 18 years; * Eastern Cooperative Oncology Group (ECOG) performance status \< 2; benign and malignant tumors for which the use of radiotherapy is well established in the literature; * tumors =or\> 340 cm³ or with a largest diameter =or\> 7 cm; * no indication for any other type of treatment due to lack of proven clinical benefit (surgery, chemotherapy, standard radiotherapy, immunotherapy, targeted therapy, etc.); * Palliative Prognostic Index (PPI) =or\< 2; * metastatic disease in the central nervous system (CNS), if present, controlled (up to 3 metastases, each up to 1 cm); * up to 5 extracranial distant metastases (nodal or extranodal) =or\< 5 cm; signed Informed Consent Form (ICF).
Exclusion criteria
* cases in which tumor volume and/or the patient's clinical condition make adequate immobilization/simulation impossible; * previous local radiotherapy; * pregnant patients; * autoimmune diseases; * genetic instability syndromes; * ongoing systemic therapy; * renal insufficiency that prevents the use of iodinated contrast.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of local control at 12 months | From enrollment to the end of treatment at 12 months | Percentage of participants achieving local control, defined as absence of local tumor progression assessed by imaging (CT). |
| Tumor volume shrinkage at 12 months | From enrollment to the end of treatment at 12 months | Percentage reduction in gross tumor volume (GTV) measured by CT at 12 months compared to baseline, calculated as \[(baseline volume - follow-up volume) / baseline volume\] × 100. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 12-month overall survival rate | 12 months overall survival | Percentage of participants alive at 12 months after treatment initiation. Overall survival is defined as the time from enrollment to death from any cause. |
| 12-month progression-free survival rate | 12 months Progression Free Survival | Percentage of participants alive and without disease progression at 12 months after treatment initiation. Progression is assessed by CT imaging. Time is measured from enrollment to the first documented disease progression or death from any cause, whichever occurs first. |
| Rate of acute adverse events assessed by CTCAE v 5.0 | 15 days, 1 month and 3 months after treatment initiation | Incidence and severity of acute adverse events assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0 (NCI CTCAE v5.0). Reported as the percentage of participants experiencing grade ≥1 adverse events. Assessed at 15 days, 1 month, and 3 months after treatment initiation. |
| Rate of late adverse events assessed by CTCAE v5.0 | 6, 9 and 12 months after treatment completion | Incidence and severity of late adverse events assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0 (NCI CTCAE v5.0). Reported as the percentage of participants experiencing grade ≥1 adverse events. Assessed at 6, 9, and 12 months after treatment completion. |
| Mean EORTC QLC-C30 Global Health Status / Quality of Life Score) | Impact in quality of life in 1, 3, 6, 9 and 12 months after treatment completion | Quality of life assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). The Global Health Status/QoL subscale is scored from 0 to 100, where higher scores indicate better quality of life. Assessed at 1, 3, 6, 9, and 12 months after treatment. |
Countries
Brazil
Contacts
CONTACTPrincipal Investigator
PRINCIPAL_INVESTIGATORHeloisa de Andrade Carvalho, MD, PhD
University of Sao Paulo
Outcome results
None listed