About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age: 18 years to 60 years
Incompletely resected supratentorial WHO II astrocytoma, oligodendroglioma or oligodendroastrocytoma
Karnofsky Performance Score ≥ 60
Adequate bone marrow, liver and renal function
Disqualifiers
Refusal to participate the study
Known hypersensitivity or contraindication to temozolomide
Previous irradiation, prior radiosurgery or prior chemotherapy
Pregnant or lactating females
Trial design
Parallel
Treatments tested in this trial
Radiotherapy
RadiationExternal beam radiation: 54.0 Gy in 27 - 30 fractions over 6 - 7 weeks.
Temozolomide
Drugdosed at 200 mg/m2 (150 mg/m2 for the first cycle) daily for 5 consecutive days, repeated every 28 days.
Treatment groups
Trial outcomes
Primary outcomes
Progression-free survival
Secondary outcomes
Quality of life
Sponsors and contacts
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