Skip to content
DataLookout
Menu

PDT-rGBMNCT07832448

Microsurgical Resection Combined With Photodynamic Therapy for Recurrent Glioblastoma

StatusActive, Not Recruiting
PhaseNot applicable
Primary completion (estimated)
Track this trial

Free. We email you which fields changed when ClinicalTrials.gov updates this record.

Record History

All 1 version: 1 with changes below.

  1. Study First Submitted

Endpoints

Primary

Rate of tumor recurrence or progression within 2 years after surgery
Timeframe: 24 months after surgery (brain MRI every 2 months)

Secondary (4)

Recurrence-free survival (RFS)
Overall survival (OS)
Incidence of adverse events, including skin phototoxicity
Change in quality of life (EORTC QLQ-C30)

Arms and interventions

Microsurgical Resection + PDTExperimental

Patients receive hematoporphyrin injection (Hiporfin) 5 mg/kg intravenously in 250 mL normal saline under light protection 48-72 hours before surgery, after a negative skin test. Standard craniotomy with microsurgical resection of recurrent glioblastoma is performed, followed by intraoperative irradiation of the resection cavity with a 630-nm semiconductor laser (1 W, 120-150 mW/cm2, 150-200 J/cm2). Dexamethasone 10 mg IV daily for 3 days preoperatively. Postoperative whole-body light protection for 72 hours and avoidance of direct sunlight for 30 days.

Drugs: Hematoporphyrin Injection (Hiporfin)

Procedures: Microsurgical Tumor Resection

Devices: 630-nm Semiconductor Laser

Sites

1 site in 1 country

  • Sun Yat-sen University Cancer CenterGuangzhou, Guangdong, China