Comparing radiotherapy alone to radiotherapy with temozolomide for treating high-risk low-grade gliomas after surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effectiveness of combining radiotherapy with temozolomide in patients with high-risk low-grade gliomas following surgical intervention. The study aims to determine if this combination can enhance progression-free survival (PFS) and overall survival (OS) compared to radiotherapy alone. It focuses on patients with newly diagnosed supratentorial WHO grade II gliomas, assessing their response to treatment over time. The trial is particularly relevant in China, where alternative chemotherapy options are limited.

Why it matters

Who can join: the full rules

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. -

Where it's running

• Xingchen Peng
  Chengdu, Sichuan, China Recruiting

Study contacts

• Principal investigator: Xingchen Peng, Ph.D — West China Hospital
• Study coordinator: Xingchen Peng, Ph.D
• Email: pxx2014@scu.edu.cn
• Phone: +86 18980606753

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.