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 2 March 2022

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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 Identifier	NCT04316039
Sponsor	West China Hospital
Last Modified on	2 March 2022

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