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Randomized Controlled Trial of Radiation Therapy versus Radiation Therapy Plus Temozolomide for High-Risk Low-Grade Gliomas

Randomized Controlled Trial of Radiation Therapy versus Radiation Therapy Plus Temozolomide for High-Risk Low-Grade Gliomas

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800015199
Enrollment
Unknown
Registered
2018-03-13
Start date
2018-06-01
Completion date
Unknown
Last updated
2018-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

High-Risk Low-Grade Gliomas

Interventions

Experimental:radiotherapy plus temozolomide

Sponsors

West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Supratentorial WHO grade II astrocytoma, oligodendroglioma, or mixed oligo-astrocytoma; 2. Aged 18 to 39 years with subtotal resection/biopsy, or aged 40 to 70 years with any extent of resection/biopsy; 3. Karnofsky performance score (KPS) = 60; (no, mild, or moderate neurologic symptoms and signs); 4. Patients have to be entered onto the study within 12 weeks of surgery; 5. Have signed consent form.

Exclusion criteria

Exclusion criteria: 1. WHO grade 1 gliomas or high-grade gliomas; 2. tumors spread to noncontiguous cranial or spinal leptomeninges; 3. gliomatosis cerebri; 4. have accepted prior chemotherapy or radiation therapy to the brain or head and neck region; 5. synchronous malignancy excluding carcinoma of the cervix in situ or nonmelanomatous skin cancer; 6. prior malignancy unless disease-free survival for more than 5 years; 7. have active infection or patients are pregnant,breast-feeding,or unable or unwilling to consider the use of effective contraception during treatment

Design outcomes

Primary

MeasureTime frame
progression-free survival;

Secondary

MeasureTime frame
overall survival;cognitive function;adverse events;

Countries

China

Contacts

Public ContactPing Ai

Department of Head and neck oncology, West China Hospital, Sichuan University

aiping00222@163.com+86 18980602055

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 1, 2026