NCT07668869 TTFields Plus FET-PET-Guided Stereotactic Radiosurgery Versus TTFields Alone for Recurrent Glioblastoma (Tarrget 2.0)
| NCT ID | NCT07668869 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Prof. Franciszek Lukaszczyk Memorial Oncology Center |
| Condition | Glioblastoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 92 participants |
| Start Date | 2025-12-30 |
| Primary Completion | 2030-06 |
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.
This trial targets 92 participants in total. It began in 2025-12-30 with a primary completion date of 2030-06.
⚠ 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
This study evaluates whether the addition of FET-PET-guided stereotactic radiosurgery (SRS) to Tumor Treating Fields (TTFields) improves survival outcomes in patients with recurrent IDH-wildtype glioblastoma. Patients with recurrent glioblastoma have limited treatment options and poor prognosis. TTFields is a non-invasive antimitotic therapy that has demonstrated efficacy in recurrent glioblastoma. Stereotactic radiosurgery is commonly used in selected patients with recurrent disease; however, treatment efficacy may be limited by the infiltrative nature of glioblastoma and challenges in accurate target delineation. The study hypothesizes that combining TTFields with FET-PET-guided stereotactic radiosurgery will improve one-year overall survival compared with TTFields alone. Participants will be randomized in a 1:1 ratio to receive either TTFields plus stereotactic radiosurgery or TTFields alone.
Eligibility Criteria
Inclusion Criteria: * Age ≥18 years * Karnofsky Performance Status ≥70 * Histologically confirmed IDH-wildtype glioblastoma * First, second, or third recurrence * Radiological recurrence according to RANO 2.0 criteria * Prior radiotherapy and temozolomide treatment * At least 6 months since completion of previous radiotherapy * Contrast-enhancing recurrent lesion visible on MRI * Maximum recurrent lesion diameter ≤5 cm * Available molecular profile including IDH and MGMT status * Adequate hematologic, renal, and hepatic function * Written informed consent Exclusion Criteria: * Previous bevacizumab treatment * Planned chemotherapy or targeted therapy after study intervention * Previous stereotactic re-irradiation within the planned treatment field * More than three recurrences * Significant psychiatric disorders * Significant unrelated neurological disease * Implanted pacemaker, defibrillator, deep brain stimulator, or other incompatible electronic device * Pregnancy or breastfeeding * Active intracranial hemorrhage * Uncontrolled hypertension * Severe renal dysfunction * Participation in another interventional study likely to interfere with this study
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07668869 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Glioblastoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07668869 currently recruiting?
Yes, NCT07668869 is actively recruiting participants. Contact the research team at glejak@co.bydgoszcz.pl for enrollment information.
Where is the NCT07668869 trial being conducted?
This trial is being conducted at Bydgoszcz, Poland.
Who is sponsoring the NCT07668869 clinical trial?
NCT07668869 is sponsored by Prof. Franciszek Lukaszczyk Memorial Oncology Center. The trial plans to enroll 92 participants.
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