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

Who is this study for? Patients with Glioma
What treatments are being studied? Intensity Modulated Radiation Therapy
Status: Recruiting
Location: See location...
Intervention Type: Drug, Radiation
Study Type: Interventional
Study Phase: Phase 2/Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• 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. -

Locations
Other Locations
China
Xingchen Peng
RECRUITING
Chengdu
Contact Information
Primary
Xingchen Peng, Ph.D
pxx2014@scu.edu.cn
+86 18980606753
Time Frame
Start Date: 2018-04-10
Estimated Completion Date: 2028-12-31
Participants
Target number of participants: 250
Treatments
Experimental: RT+TMZ
Active_comparator: RT
Related Therapeutic Areas
Sponsors
Leads: West China Hospital

This content was sourced from clinicaltrials.gov

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