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

Sponsor

West China Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT04316039

Collaborator

(none)

250

Enrollment

Location

Arms

128.7

Anticipated Duration (Months)

1.9

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Low-grade Glioma	Drug: Temozolomide Radiation: intensity modulated radiation therapy	Phase 2/Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

250 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Apr 10, 2018

Anticipated Primary Completion Date :

Apr 10, 2023

Anticipated Study Completion Date :

Dec 31, 2028

Arms and Interventions

Arm	Intervention/Treatment
Experimental: RT+TMZ	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).
Active Comparator: RT	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).

Arm

Intervention/Treatment

Experimental: RT+TMZ

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).

Active Comparator: RT

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).

Outcome Measures

Primary Outcome Measures

Progression-free survival [up to 120 months]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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. -