Comparing radiotherapy alone to radiotherapy with temozolomide for treating high-risk low-grade gliomas after surgery
Radiotherapy Versus Radiotherapy Combined With Temozolomide in High-risk Low-grade Gliomas After Surgery
PHASE2; PHASE3 · West China Hospital · NCT04316039
This study is testing if adding a chemotherapy drug called temozolomide to radiotherapy helps people with high-risk low-grade brain tumors live longer and healthier after surgery.
Quick facts
| Phase | PHASE2; PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 250 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | West China Hospital (other) |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Chengdu, Sichuan) |
| Trial ID | NCT04316039 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 70 with newly diagnosed supratentorial WHO grade II gliomas who meet specific health criteria.
Not a fit: Patients with high-grade gliomas, prior radiation therapy, or those with active infections will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve survival outcomes for patients with high-risk low-grade gliomas.
How similar studies have performed: While similar approaches have been explored, this specific combination of treatments in this patient population is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Chengdu, Sichuan
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Low-grade Glioma, low-grade glioma, High-risk, Radiotherapy, Temozolomide