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

Who is this study for? Adult patients with Astrocytoma
What treatments are being studied? Temozolomide
Status: Recruiting
Location: See location...
Intervention Type: Drug, Radiation
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
China
Sun Yat-sen University Cancer Center
RECRUITING
Guangzhou
Contact Information
Primary
Zhong-ping CHEN, MD, PhD
chenzhp@sysucc.org.cn
+86-20-87343310
Backup
Ke SAI, MD, PhD
saike@sysucc.org.cn
+86-20-87343656
Time Frame
Start Date: 2012-07
Estimated Completion Date: 2026-08
Participants
Target number of participants: 290
Treatments
Experimental: Radiotherapy plus adjuvant temozolomide
Radiation therapy will start within 8 weeks after neurosurgical procedures. The residue gliomas will receive a total dose of 54.0 Gy in 27 - 30 fractions over 6 - 7 weeks. Four weeks after radiotherapy, patients will then receive 6 cycle of temozolomide dosed at 200 mg/m2 (150 mg/m2 for the first cycle) daily for 5 consecutive days, repeated every 28 days.
Active_comparator: Radiotherapy
Radiation therapy will start within 8 weeks after neurosurgical procedures. The residue gliomas will receive a total dose of 54.0 Gy in 27 - 30 fractions over 6 - 7 weeks.
Sponsors
Leads: Sun Yat-sen University

This content was sourced from clinicaltrials.gov