Astrocytoma, Oligodendroastrocytoma, Oligodendroglioma
Conditions
Keywords
low-grade glioma, radiotherapy, chemotherapy
Brief 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.
Interventions
RADIATIONRadiotherapy
External beam radiation: 54.0 Gy in 27 - 30 fractions over 6 - 7 weeks.
DRUGTemozolomide
dosed at 200 mg/m2 (150 mg/m2 for the first cycle) daily for 5 consecutive days, repeated every 28 days.
Sponsors
Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* 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 * Ability of subject to understand character and individual consequences of the clinical trial * Written informed consent
Exclusion criteria
* Refusal to participate the study * Known hypersensitivity or contraindication to temozolomide * Previous irradiation, prior radiosurgery or prior chemotherapy * Pregnant or lactating females * Malignant tumor other than brain tumor * Contraindicated for MRI examination * Unable to comply with the follow-up studies of this trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival | 5 years |
Secondary
| Measure | Time frame |
|---|---|
| Quality of life | 5 years |
Countries
China
Contacts
Primary ContactZhong-ping CHEN, MD, PhD
Backup ContactKe SAI, MD, PhD
Outcome results
None listed