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Search / Trial NCT01649830

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

Launched by SUN YAT-SEN UNIVERSITY · Jul 24, 2012

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Low Grade Glioma Radiotherapy Chemotherapy

ClinConnect Summary

This clinical trial is studying the effectiveness of a treatment called temozolomide (TMZ) given after radiation therapy for patients with low-grade gliomas (LGG), which are a type of brain tumor. The goal is to see if combining these treatments can help patients live longer without their tumors progressing, while also maintaining a good quality of life. Researchers will compare this combination treatment to radiation therapy alone to determine which is more beneficial for patients who have not had their tumors completely removed.

To participate in this trial, individuals must be between 18 and 60 years old and have a specific type of brain tumor that has not been fully removed during surgery. They should also be in decent overall health, as determined by a performance score, and must be able to understand the trial and give their consent. Participants can expect regular check-ups and monitoring throughout the study to track their health and response to the treatment. It's important to know that certain people, such as those with prior treatments or specific health conditions, may not be eligible for this trial.

Gender

ALL

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

About Sun Yat Sen University

Sun Yat-sen University, a prestigious institution located in Guangzhou, China, is dedicated to advancing medical research and healthcare innovations. As a leading clinical trial sponsor, the university leverages its extensive academic resources and collaboration with top-tier medical professionals to conduct rigorous clinical studies. Committed to improving patient outcomes and contributing to global health knowledge, Sun Yat-sen University focuses on a wide range of therapeutic areas, employing cutting-edge methodologies to ensure the integrity and efficacy of its research initiatives. Through its clinical trials, the university aims to foster scientific advancements and enhance the quality of care provided to patients both locally and internationally.

Locations

Guangzhou, Guangdong, China

Patients applied

0 patients applied

Trial Officials

Zhong-ping CHEN, MD, PhD

Principal Investigator

Sun Yat-sen University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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