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

Study Overview
=================
Brief 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.

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

Conditions
-----------------
Astrocytoma, Oligodendroglioma, Oligodendroastrocytoma

Intervention / Treatment
-----------------
* Radiation: Radiotherapy
* Drug: Temozolomide


Participation Criteria
=================
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 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Radiotherapy plus adjuvant temozolomide<br>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. | Radiation: Radiotherapy<br>* External beam radiation: 54.0 Gy in 27 - 30 fractions over 6 - 7 weeks.<br>Drug: Temozolomide<br>* dosed at 200 mg/m2 (150 mg/m2 for the first cycle) daily for 5 consecutive days, repeated every 28 days.<br>|
| Active Comparator: Radiotherapy<br>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. | Radiation: Radiotherapy<br>* External beam radiation: 54.0 Gy in 27 - 30 fractions over 6 - 7 weeks.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life |  | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
low-grade glioma, radiotherapy, chemotherapy