Efficacy of Post-radiation Adjuvant Temozolomide Chemotherapy in Residue Low-grade Glioma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Radiotherapy, Temozolomide.
- Who it may be relevant to
- Registry conditions: Astrocytoma, Oligodendroglioma, Oligodendroastrocytoma. Basic parameters: 18 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Radiation Radiotherapy
External beam radiation: 54.0 Gy in 27 - 30 fractions over 6 - 7 weeks. - Drug Temozolomide
dosed at 200 mg/m2 (150 mg/m2 for the first cycle) daily for 5 consecutive days, repeated every 28 days.
Primary outcome measures
- Progression-free survival [Time frame: 5 years]
Secondary outcome measures (1)
- Quality of life [Time frame: 5 years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Sun Yat-sen University Cancer Center — Guangzhou
Identifiers
NCT: NCT01649830 · 2012012