Efficacy of Post-radiation Adjuvant Temozolomide Chemotherapy in Residue Low-grade Glioma
Recruiting
Phase 3
Interventional Study
Astrocytoma
Oligodendroglioma
Oligodendroastrocytoma
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 60
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 290 (estimated)
- Sponsor
- Sun Yat-sen University · Other
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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 rec…
Trial Locations
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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 cons…
Contacts