Hypofractionated Radiotherapy
This study was a multicenter, open-label, randomized, controlled, phase Ⅲ clinical trial to evaluate the efficacy and safety of hypofractionated concurrent radiotherapy followed by sequential temozolomide after surgery in patients with newly diagnosed glioblastoma. A total of 420 subjects were enrolled in this study, r
| Condition(s) | Glioblastoma |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | This study was a multicenter, open-label, randomized, controlled, phase Ⅲ clinical trial to evaluate the efficacy and safety of hypofractionated concurrent radiotherapy followed by sequential temozolomide after surgery in patients with newly diagnosed glioblastoma. A total of 420 subjects were enrolled in this study, randomized 1:1. According to the changes in overall survival time after postoperative concurrent chemoradiotherapy with different radiation doses, the stratification factors included the extent of surgical resection (total resection vs subtotal resection); The time of postoperative concurrent chemoradiotherapy (less than 28 days or more than 28 days); MGMT promoter methylation expression (positive or negative). The study design was as follows: Participants were required to und |
| Who can participate | Inclusion Criteria: 1. Newly diagnosed glioblastoma confirmed by histopathology or molecular pathology; 2. Complete or partial tumor resection or biopsy via neurosurgery; 3. The age of signing the informed consent form was 18-70 years old, male or female; (4) KPS score ≥60; (5) expected survival time ≥6 months; 6\. Radiotherapy should be started within 6 weeks after surgery; 7. Vital organ function meets the following requirements (excluding the use of any blood components and cell growth factors within 14 days) : Normal bone marrow reserve: white blood cell (WBC) ≥3.0×109/L, neutrophil count (NEUT) ≥1.5×109/L, platelet count (PLT) ≥80×109/L, hemoglobin (Hb) ≥90 g/L Normal renal function or serum creatinine (SCr) ≤ 1.5 times the upper limit of normal (ULN) or creatinine clearance ≥50 ml/ m |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Lead sponsor | The First Hospital of Jilin University |
| Locations | Changchun, Jilin, China |
| Start date | 2024-08-13 |
| NCT ID | NCT06740955 |
| Official listing | https://clinicaltrials.gov/study/NCT06740955 |