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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-60
SponsorSun Yat-sen University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Refusal to participate the study

Known hypersensitivity or contraindication to temozolomide

Previous irradiation, prior radiosurgery or prior chemotherapy

Pregnant or lactating females

Trial design

Design model

Parallel

Treatments tested in this trial

  • Radiotherapy

    Radiation

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

  • Temozolomide

    Drug

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

Treatment groups

290 Participants
are divided into 2 treatment groups
Group A: Radiotherapy plus adjuvant temozolomideExperimental treatment 2 interventions
Group B: RadiotherapyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Progression-free survival

Time frame
5 years

Secondary outcomes

1

Quality of life

Time frame
5 years

Other outcomes

Sponsors and contacts

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