Treatment Strategy for Low-grade Gliomas

Sun Yat-sen University

Status and phase: Terminated; Phase 3

Conditions: Oligodendrogliomas; Oligoastrocytoma; Astrocytomas

Treatments: Radiation: Radiation therapy; Drug: Temozolomide

Study type: Interventional

Funder types: Other

Identifiers

NCT00897377

YP2008009

Details and patient eligibility

About

Although the prognosis of patients with low-grade glioma (LGG) is generally good, recurrence seems unavoidable in some patients because of the infiltrative growth of the tumors. How to treat LGGs is still under controversy. The role of radiation therapy and chemotherapy in the treatment of LGG need to be further investigated. The purpose of this study is the following:

1. to investigate the role of early radiation therapy in MRI-determined total resected LGGs;
2. to compare the efficacy of early radiation therapy and that of initial chemotherapy in the LGGs without total resection.

Enrollment: 500 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically confirmed newly diagnosed low-grade gliomas
• Karnofsky performance status of 60 or more

Exclusion criteria

• Previous history of radiation therapy or chemotherapy for gliomas
• Pregnant or breast feeding
• Diagnosis of another malignancy may exclude subject from study
• Evidence or history of bleeding diathesis
• Evidence or history of hypersensitivity to temozolomide

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

500 participants in 4 patient groups

Total resection with early radiation

Experimental group

Description:

Total resected LGGs treated with early radiation

Treatment:

Radiation: Radiation therapy

Total resection without radiation

No Intervention group

Description:

Total resected LGGs treated without radiation

Residual LGGs with radiation

Experimental group

Description:

Residual LGGs treated with early radiation

Treatment:

Radiation: Radiation therapy

Residual LGGs with chemo

Experimental group

Description:

Residual LGGS treated with temozolomide

Treatment:

Drug: Temozolomide