| NCT ID | NCT07645261 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University of Sao Paulo General Hospital |
| Condition | Cancer (Advanced Stage) |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2026-04-28 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 20 participants in total. It began in 2026-04-28 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Heloisa de Andrade Carvalho, MD, PhD
PRINCIPAL INVESTIGATOR
University of Sao Paulo
Frequently Asked Questions
Who can join the NCT07645261 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cancer (Advanced Stage). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07645261 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07645261 currently recruiting?
Yes, NCT07645261 is actively recruiting participants. Contact the research team at heloisa.carvalho@hc.fm.usp.br for enrollment information.
Where is the NCT07645261 trial being conducted?
This trial is being conducted at São Paulo, Brazil.
Who is sponsoring the NCT07645261 clinical trial?
NCT07645261 is sponsored by University of Sao Paulo General Hospital. The principal investigator is Heloisa de Andrade Carvalho, MD, PhD at University of Sao Paulo. The trial plans to enroll 20 participants.
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