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

RecruitingPhase 2, Phase 3Ages 18 Years - 70 YearsAllWest China Hospital
NCT04316039 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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. -
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What it tests

  • Temozolomide
  • intensity modulated radiation therapy
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Where

1 site
Xingchen Peng
Chengdu, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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