Radiotherapy Versus Radiotherapy Combined With Temozolomide in High-risk Low-grade Gliomas After Surgery

Study Overview
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Brief Summary
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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.

Official Title
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Radiotherapy Versus Radiotherapy Combined With Temozolomide in High-risk Low-grade Gliomas After Surgery

Conditions
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Low-grade Glioma

Intervention / Treatment
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* Drug: Temozolomide
* Radiation: intensity modulated radiation therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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. -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RT+TMZ<br> | Drug: Temozolomide<br>* 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.<br>Radiation: intensity modulated radiation therapy<br>* The radiation dose is 50-54 Gy given in 25-30 fractions (1.8-2.0 Gy once daily, 5 days per week).<br>|
| Active Comparator: RT<br> | Radiation: intensity modulated radiation therapy<br>* The radiation dose is 50-54 Gy given in 25-30 fractions (1.8-2.0 Gy once daily, 5 days per week).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival | 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. | up to 120 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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low-grade glioma, High-risk, Radiotherapy, Temozolomide