Low-grade Glioma
Conditions
Keywords
low-grade glioma, High-risk, Radiotherapy, Temozolomide
Brief summary
It has been reported that radiation therapy followed by PCV chemotherapy (procarbazine, lomustine and vincristine) could improve progression-free survival (PFS) and overall survival (OS) in patients with high-risk WHO grade 2 gliomas after surgery. However, procarbazine is not available in China. In clinical practice, Chinese doctors often use radiotherapy combined with temozolomide to treat these patients, though large-scale prospective studies are lacking. This trial aims to confirm whether RT combined with temozolomide can improve PFS and OS in patients with high-risk low-grade gliomas.
Interventions
DRUGTemozolomide
Concurrent chemotherapy is to receive oral temozolomide, 75 mg/m2 per day, during radiation therapy. Adjuvant chemotherapy will be treated with six cycles of temozolomide, 150 to 200 mg/m2 per day for five consecutive days, repeated every 4 weeks. There is a 28-day break during radiotherapy and adjuvant temozolomide.
RADIATIONintensity modulated radiation therapy
The radiation dose is 50-54 Gy given in 25-30 fractions (1.8-2.0 Gy once daily, 5 days per week).
Sponsors
West China Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Newly diagnosed supratentorial WHO grade II gliomas; 2. Aged 18 to 39 years without total resection, or aged 40 to 70 years with any extent of resection or biopsy; 3. Karnofsky performance score (KPS) ≥ 60; 4. No more than moderate neurologic symptoms and signs; 5. The interval between surgery and randomization is less than 12 weeks; 6. Have signed the consent form. -
Exclusion criteria
1. WHO grade I gliomas or high-grade gliomas according to WHO's grading system; 2. Have received prior radiation therapy to the head and neck region; 3. Have received prior chemotherapy; 4. Synchronous multiple primary malignant tumor excluding carcinoma of the cervix in situ or nonmelanomatous skin cancer; 5. Prior malignancy's disease-free survival less than 5 years; 6. Have active infection; 7. Patients are pregnant or breast-feeding. -
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival | up to 120 months | Our primary outcome is progression-free survival which is calculated from the date of randomization to the date of first reported disease progression or the date of death. |
Countries
China
Contacts
Primary ContactXingchen Peng, Ph.D
Outcome results
None listed