Clinical trial · Interventional
Treatment of High-grade Gliomas Using Hypofractionated Radiation Therapy -a Phase I Clinical Trial
Treatment of High-grade Gliomas Using Escalating Doses of Hypofractionated Simultaneous Integrated Boost-intensity Modulated Radiation Therapy in Combination With Temozolomide - a Modified Phase I Clinical Trial
- 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)
Postoperative conventional radiation at 60 Gy/30f is currently still considered the standard radiotherapy mode for high-grade gliomas; however, the efficacy is still unsatisfactory. Studies in recent years have shown that hypofractionated simultaneous integrated boost-intensity modulated radiation therapy (SIB-IMRT) has certain survival benefits over other fractionation methods; but, the best hypofractionation mode and its efficacy have not been confirmed. The purpose of this study is to investigate the maximum tolerated dose (MTD) of hypofractionated SIB-IMRT with stepwise escalating of doses combined with temozolomide (TMZ) for the treatment of malignant gliomas.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Glioma | Glioma | ONTOLOGY_EXACT | 0.98 |
| Maximum Tolerated Dose | — | UNRESOLVED | — |
| Radiotherapy, Intensity-Modulated | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| hypofractionated radiation | Radiation | — | UNRESOLVED |
| Temozolomide chemotherapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- hypofractionated group
- description
- hypofractionated group using hypofractionated radiation with temozolomide chemotherapy: Malignant gliomas patients received concurrent postoperative radiotherapy and chemotherapy.Intensity-modulated radiotherapy is adopted, the dose at each fraction is gradually increased from 2.8 Gy/f (total of 20 times) with an escalating dose interval of 0.4 Gy in PTV1. The planning target volume (PTV2) remain unchanged with 2.5 Gy each time and a total of 50 Gy/20 f. Temozolomide is administered orally every day at 75 mg/m2 during radiotherapy and at 150-200 mg/m2 for 12 cycles following completion of chemoradiotherapy.
- interventionNames
- Radiation: hypofractionated radiation
- Drug: Temozolomide chemotherapy
Primary outcomes (1)
- measure
- the maximum tolerated dose(MTD)
- timeFrame
- 1year
- description
- Safety and tolerability of hypofractionated simultaneous integrated boost intensity modulated radiation therapy (SIB-IMRT) combined with standard temozolomide chemotherapy. The maximum tolerated dose of hypofractionated radiation combined with concurrent temozolomide in newly diagnosed highgrade glioma is being explored.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Postoperative grades III and IV glioma patients confirmed by pathology. 2. The ages are between 18-70 years. 3. Karnofsky performance score（KSP）≧60. 4. Expected survival period ≧3 months. 5. Blood routine and liver and kidney functions are normal. 6. Receive cranial MRI examination after 48 h of surgery. 7. Radiotherapy is performed after 2-4 weeks of surgery. 8. Patients with restricted lesions and non-diffuse growth. 9. Maximum diameter of the residual tumor, surgical cavity, and primary tumor bed are ≦6 cm. Exclusion Criteria: 1. Lesions are in the brain stem and thalamus. 2. Pregnant and lactating women. 3. Secondary primary malignant tumor. 4. Severe pulmonary infection. 5. Combination with mental illness or another disease that require hospitalization. 6. Patients had received chemotherapy or brain radiotherapy previously.
References
Publications (0)
Data not yet available