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

StatusUnknown
PhasePhase 3
Started2012-07
View on ClinicalTrials.gov ↗
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.

Amendment history

2026-09-06
minor
Trial status changed: Recruiting → Unknown
2020-05-26
minor
Study Status, Contacts/Locations v6
Trial statusRecruiting→Unknown
Primary completion date2021-08→2025-08
Completion date2022-08→2026-08
2017-10-06
minor
3 amendments v3-v5
3 re-verifications since 2015-12-10, no change to tracked fields
2014-08-02
minor
Study Status, Study Design v2
Enrollment target350→290
2014-05-26
minor
Study Status v1
Re-verified, no change to tracked fields
2012-07-24
minor
Original filing
666 trials monitored
See 38 trials at risk
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.
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