Efficacy of Post-radiation Adjuvant Temozolomide Chemotherapy in Residue Low-grade Glioma
- Trial number:
- NCT01649830
- Trial phase:
- 3
- Study type:
- Chemotherapy, Local/Regional therapies
- Overall status:
- Recruiting
Study start date
July, 2012
Scientific title
Efficacy of Post-radiation Adjuvant Temozolomide Chemotherapy in Residue Low-grade Glioma
Summary
Low-grade glioma (LGG) is a common primary brain tumor in young adults. The infiltrative nature and frequent growth in eloquent area in brain often makes total resection impossible. Until now, no agreement has been achieved on the treatment of LGG without total resection. Post-radiation adjuvant temozolomide (TMZ) is currently the standard of care for high-grade gliomas. Radiotherapy or TMZ is recommended for the treatment of residue low-grade gliomas. However, the efficacy of combined radiotherapy with adjuvant TMZ for residue LGG remains to be defined. In this randomized controlled trial, the investigators will test the hypothesis that radiotherapy with subsequent TMZ chemotherapy is superior to improve the progression-free survival of patients with residue LGG without significant impairment to quality of life compared to radiotherapy alone.
Age: 18 years to 60 yearsIncompletely resected supratentorial WHO II astrocytoma, oligodendroglioma or oligodendroastrocytoma Karnofsky Performance Score ≥ 60 Adequate bone marrow, liver and renal function Ability of subject to understand character and individual consequences of the clinical trial Written informed consent
Study design
Primary purpose:
Treatment, Allocation:
Randomized, Intervention model:
Parallel Assignment, Masking:
None (Open Label),
Conditions
Oligodendroastrocytoma, Astrocytoma, Oligodendroglioma
Other study ID numbers
2012012
Choose trial site (1)
Sun Yat-sen University Cancer Center
651 Dongfeng E Rd, Yuexiu Qu, Guangzhou Shi, Guangdong Sheng, China