Actively Recruiting

Phase 3
Age: 18Years - 60Years
All Genders
NCT01649830

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

Led by Sun Yat-sen University · Updated on 2020-05-28

290

Participants Needed

1

Research Sites

734 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 60Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 60 years
  • Diagnosis of incompletely resected supratentorial WHO grade II astrocytoma, oligodendroglioma, or oligodendroastrocytoma
  • Karnofsky Performance Score of 60 or higher
  • Adequate bone marrow, liver, and kidney function
  • Ability to understand the trial and its consequences
  • Provided written informed consent
Not Eligible

You will not qualify if you...

  • Refusal to participate in the study
  • Known hypersensitivity or contraindication to temozolomide
  • Previous radiation therapy, radiosurgery, or chemotherapy
  • Pregnant or breastfeeding women
  • Having a malignant tumor other than a brain tumor
  • Contraindications to MRI examination
  • Unable to comply with follow-up requirements of the trial

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China, 510060

Actively Recruiting

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Research Team

Z

Zhong-ping CHEN, MD, PhD

CONTACT

K

Ke SAI, MD, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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