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

May 26, 2020 updated by: Zhongping Chen, Sun Yat-sen University
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

290

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Recruiting
        • Sun Yat-sen University Cancer Center
        • Principal Investigator:
          • Zhong-ping CHEN, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Radiotherapy plus adjuvant temozolomide
Radiation therapy will start within 8 weeks after neurosurgical procedures. The residue gliomas will receive a total dose of 54.0 Gy in 27 - 30 fractions over 6 - 7 weeks. Four weeks after radiotherapy, patients will then receive 6 cycle of temozolomide dosed at 200 mg/m2 (150 mg/m2 for the first cycle) daily for 5 consecutive days, repeated every 28 days.
Radiation: Radiotherapy
External beam radiation: 54.0 Gy in 27 - 30 fractions over 6 - 7 weeks.
Drug: Temozolomide
dosed at 200 mg/m2 (150 mg/m2 for the first cycle) daily for 5 consecutive days, repeated every 28 days.
Active Comparator: Radiotherapy
Radiation therapy will start within 8 weeks after neurosurgical procedures. The residue gliomas will receive a total dose of 54.0 Gy in 27 - 30 fractions over 6 - 7 weeks.
Radiation: Radiotherapy
External beam radiation: 54.0 Gy in 27 - 30 fractions over 6 - 7 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression-free survival
Time Frame: 5 years
5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Quality of life
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Investigators

  • Principal Investigator: Zhong-ping CHEN, MD, PhD, Sun Yat-sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (Anticipated)

August 1, 2025

Study Completion (Anticipated)

August 1, 2026

Study Registration Dates

First Submitted

July 20, 2012

First Submitted That Met QC Criteria

July 24, 2012

First Posted (Estimate)

July 25, 2012

Study Record Updates

Last Update Posted (Actual)

May 28, 2020

Last Update Submitted That Met QC Criteria

May 26, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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