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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

290 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2026-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Astrocytoma Oligodendroglioma Oligodendroastrocytoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Radiotherapy

Intervention Type RADIATION

External beam radiation: 54.0 Gy in 27 - 30 fractions over 6 - 7 weeks.

Temozolomide

Intervention Type DRUG

dosed at 200 mg/m2 (150 mg/m2 for the first cycle) daily for 5 consecutive days, repeated every 28 days.

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.

Group Type ACTIVE_COMPARATOR

Radiotherapy

Intervention Type RADIATION

External beam radiation: 54.0 Gy in 27 - 30 fractions over 6 - 7 weeks.

Interventions

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Radiotherapy

External beam radiation: 54.0 Gy in 27 - 30 fractions over 6 - 7 weeks.

Intervention Type RADIATION

Temozolomide

dosed at 200 mg/m2 (150 mg/m2 for the first cycle) daily for 5 consecutive days, repeated every 28 days.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No