Treatment of High-grade Gliomas Using Hypofractionated Radiation Therapy -a Phase I Clinical Trial
Condition: Glioma; Radiotherapy, Intensity-Modulated; Maximum Tolerated Dose
MeSH terms: Glioma
Study type: Interventional

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.
    

Detailed description: 
      Background: 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. Methods: Malignant gliomas
      patients receive concurrent postoperative radiotherapy and chemotherapy. 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. The planning
      target volume (PTV2) including the 2cm region around surgical cavity and residual tumor
      remain unchanged, with 2.5 Gy each time and a total of 50 Gy/20f. The subsequent group of
      patients is advanced to the next dose level until dose-limiting toxicity (DLT) is present.
      The dose, one level lower than the DLT, is the MTD. The highest target single dose is 4 Gy/f.
      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.
    

Intervention name(s): hypofractionated radiation; Temozolomide chemotherapy
Intervention type(s): Radiation; Drug
Intervention description(s): 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.; 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.
Other intervention name(s): TMZ chemotherapy
Intervention MeSH terms: Temozolomide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: malignant glioma; intensity modulated radiation therapy; simultaneous integrated boost; hypofractionation; temozolomide; maximum tolerated dose