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NCT Number: NCT01649830

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

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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Key information

Conditions

Astrocytoma Glioma Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neuroectodermal Tumors Oligodendroastrocytoma Oligodendroglioma

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location status: Recruiting

Location contact

Zhong-ping CHEN, MD, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Progression-free survival

    Time frame: 5 years

Secondary outcomes

  1. Quality of life

    Time frame: 5 years

Study contacts

Contact information is provided by the study sponsor or research team.

Ke SAI, MD, PhD

CONTACT

[email protected]

+86-20-87343656

Zhong-ping CHEN, MD, PhD

CONTACT

[email protected]

+86-20-87343310

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Important dates

Study start
2012
Primary completion
2025
Study completion
2026
First posted
Jul 25, 2012
Registry last updated
May 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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