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

Sun Yat-sen University

Status and phase: Enrolling; Phase 3

Conditions: Oligodendroglioma; Astrocytoma; Oligodendroastrocytoma

Treatments: Radiation: Radiotherapy; Drug: Temozolomide

Study type: Interventional

Funder types: Other

Identifiers

NCT01649830

2012012

Details and patient eligibility

About

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.

Enrollment: 290 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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290 participants in 2 patient groups

Radiotherapy plus adjuvant temozolomide

Experimental group

Description:

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.

Treatment:

Drug: Temozolomide

Radiation: Radiotherapy

Radiotherapy

Active Comparator group

Description:

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.

Treatment:

Radiation: Radiotherapy