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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2/PHASE3

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-10

Study Completion Date

2028-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Low-grade Glioma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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RT+TMZ

Group Type EXPERIMENTAL

Temozolomide

Intervention Type DRUG

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.

intensity modulated radiation therapy

Intervention Type RADIATION

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

RT

Group Type ACTIVE_COMPARATOR

intensity modulated radiation therapy

Intervention Type RADIATION

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

Interventions

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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.

Intervention Type DRUG

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).

Intervention Type RADIATION

Eligibility Criteria

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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. -

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No