Clinical trial · Interventional
Radiotherapy Versus Radiotherapy Combined With Temozolomide in High-risk Low-grade Gliomas After Surgery
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Low-grade Glioma | Low Grade Glioma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| intensity modulated radiation therapy | Radiation | — | UNRESOLVED |
| Temozolomide | Drug | Temozolomide | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- RT+TMZ
- interventionNames
- Drug: Temozolomide
- Radiation: intensity modulated radiation therapy
- type
- ACTIVE_COMPARATOR
- label
- RT
- interventionNames
- Radiation: intensity modulated radiation therapy
Primary outcomes (1)
- measure
- Progression-free survival
- timeFrame
- up to 120 months
- description
- 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
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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. -
References
Publications (0)
Data not yet available