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

  • STATUS
    Recruiting
  • End date
    Dec 31, 2028
  • participants needed
    250
  • sponsor
    West China Hospital
Updated on 24 January 2021
vincristine
temozolomide
lomustine

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.

Details
Condition Low Grade Glioma
Treatment Temozolomide, Intensity Modulated Radiation Therapy
Clinical Study IdentifierNCT04316039
SponsorWest China Hospital
Last Modified on24 January 2021

Eligibility

Yes No Not Sure

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. -
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