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

Astrocytoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01649830
• Other study ID #: 2012012
• Status: Recruiting
• Phase: Phase 3
• Start date: July 2012
• Est. completion date: August 2026

Study information

• Verified date: May 2020
• Source: Sun Yat-sen University
• Contact: Zhong-ping CHEN, MD, PhD
• Phone: +86-20-87343310
• Email: chenzhp[@]sysucc.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 290
• Est. completion date: August 2026
• Est. primary completion date: August 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Astrocytoma
• Glioma
• Oligodendroastrocytoma
• Oligodendroglioma

Intervention

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.

Locations

Country	Name	City	State
China	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival		5 years
Secondary	Quality of life		5 years