Treatment of High-grade Gliomas Using Hypofractionated Radiation Therapy -a Phase I Clinical Trial

• Status: Completed
• Trial end date: 2016-12-03
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Xue Xiaoying
• Treatments: Dacarbazine; Temozolomide

Criteria

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.