Radiotherapy Versus Radiotherapy Combined With Temozolomide in High-risk Low-grade Gliomas After Surgery
West China Hospital
250 participants
Apr 10, 2018
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria6
- Newly diagnosed supratentorial WHO grade II gliomas;
- Aged 18 to 39 years without total resection, or aged 40 to 70 years with any extent of resection or biopsy;
- Karnofsky performance score (KPS) ≥ 60;
- No more than moderate neurologic symptoms and signs;
- The interval between surgery and randomization is less than 12 weeks;
- Have signed the consent form. -
Exclusion Criteria7
- WHO grade I gliomas or high-grade gliomas according to WHO's grading system;
- Have received prior radiation therapy to the head and neck region;
- Have received prior chemotherapy;
- Synchronous multiple primary malignant tumor excluding carcinoma of the cervix in situ or nonmelanomatous skin cancer;
- Prior malignancy's disease-free survival less than 5 years;
- Have active infection;
- Patients are pregnant or breast-feeding. -
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Interventions
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.
The radiation dose is 50-54 Gy given in 25-30 fractions (1.8-2.0 Gy once daily, 5 days per week).
Locations(1)
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NCT04316039