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

NACompletedINTERVENTIONAL
Enrollment

16

Participants

Timeline

Start Date

January 1, 2014

Primary Completion Date

November 7, 2016

Study Completion Date

December 3, 2016

Conditions
GliomaRadiotherapy, Intensity-ModulatedMaximum Tolerated Dose
Interventions
RADIATION

hypofractionated radiation

The simultaneous integrated boost-intensity modulated technology is adopted to increase both the dose in the surgical cavity and residual tumor (PTV1).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, until dose-limiting toxicity is present,the highest target single dose is 4 Gy/f. The planning target volume (PTV2) including the 2 cm region around surgical cavity and residual tumor remain unchanged, with 2.5 Gy each time and a total of 50 Gy/20f.

DRUG

Temozolomide chemotherapy

Temozolomide(TMZ) is administered orally every day at 75 mg/m2 during radiotherapy and at 150-200 mg/m2 for 12 cycles following completion of chemoradiotherapy.

All Listed Sponsors
lead

Xue Xiaoying

OTHER

NCT03082846 - Treatment of High-grade Gliomas Using Hypofractionated Radiation Therapy -a Phase I Clinical Trial | Biotech Hunter | Biotech Hunter