SBRT-LATTICE-PATHY for Large Tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2 interventional study aims to combine SBRT and lattice radiotherapy with hypoxic tissue irradiation concepts to treat large tumors that are difficult to manage with standard techniques. The approach focuses radiation to strategic partial regions of the tumor rather than the whole volume, potentially enhancing effectiveness while reducing toxicity. Outcomes will inform whether this partial, targeted irradiation can elicit beneficial abscopal or bystander effects and improve safety profiles for large-volume tumors. Eligible patients have advanced solid tumors measuring at least 7 cm in diameter or 340 cm³, with controlled CNS metastases and limited extracranial disease, and must meet standard radiotherapy suitability criteria. The study is conducted at Hospital das Clínicas da Universidade de São Paulo, led by the University of São Paulo General Hospital, with no listed collaborators.

Why it matters

Who can join: the full rules

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.

Where it's running

• Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo - Instituto de Radiologia
  São Paulo, São Paulo, Brazil Recruiting

Study contacts

• Principal investigator: Heloisa de Andrade Carvalho, MD, PhD — University of Sao Paulo
• Study coordinator: Principal Investigator
• Email: heloisa.carvalho@hc.fm.usp.br
• Phone: 551126616722

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.