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

Low-grade Glioma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04316039
• Other study ID #: ChiCTR1800015199
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: April 10, 2018
• Est. completion date: December 31, 2028

Study information

• Verified date: March 2020
• Source: West China Hospital
• Contact: Xingchen Peng, Ph.D
• Phone: +86 18980606753
• Email: pxx2014[@]scu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: December 31, 2028
• Est. primary completion date: April 10, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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. -

Related Conditions & MeSH terms

• Glioma
• Low-grade Glioma

Intervention

Drug:
• Temozolomide
Concurrent chemotherapy is to receive oral temozolomide, 75 mg/m2 per day, during radiation therapy. Adjuvant chemotherapy will be treated with six cycles of temozolomide, 150 to 200 mg/m2 per day for five consecutive days, repeated every 4 weeks. There is a 28-day break during radiotherapy and adjuvant temozolomide.

Radiation:
• intensity modulated radiation therapy
The radiation dose is 50-54 Gy given in 25-30 fractions (1.8-2.0 Gy once daily, 5 days per week).

Locations

Country	Name	City	State
China	Xingchen Peng	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
West China Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival	Our primary outcome is progression-free survival which is calculated from the date of randomization to the date of first reported disease progression or the date of death.	up to 120 months