Clinical Trial

Efficacy of Post-radiation Adjuvant Temozolomide Chemotherapy in Residue Low-grade Glioma

Recruiting Phase 3
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Record status
This record was last updated May 28, 2020 (before its estimated August 2025 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 6 amendments
This ClinicalTrials.gov record has been amended 6 times since 2012-07-24; most recent amendment 2020-05-26.
Trial Details
NCT Number NCT01649830
Lead Sponsor Sun Yat-sen University
Conditions Astrocytoma, Oligodendroglioma, Oligodendroastrocytoma
Enrollment 290 participants
Start Date 2012-07
Primary Completion 2025-08 (estimated)
Study Completion 2026-08 (estimated)
Updated on ClinicalTrials.gov 2020-05-28