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

Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-70
SponsorWest China Hospital

About this trial

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 criteria

Qualifiers

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;

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • Temozolomide
  • intensity modulated radiation therapy

Treatment groups

250 Participants
are divided into 2 treatment groups

Sponsors and collaborators