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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Sun Yat-sen University
Sponsor:
Information provided by (Responsible Party):
Zhongping Chen, Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT01649830
First received: July 20, 2012
Last updated: August 2, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention Phase
Astrocytoma
Oligodendroglioma
Oligodendroastrocytoma
Radiation: Radiotherapy
Drug: Temozolomide
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy of Post-radiation Adjuvant Temozolomide Chemotherapy in Residue Low-grade Glioma

Resource links provided by NLM:


Further study details as provided by Sun Yat-sen University:

Primary Outcome Measures:
  • Progression-free survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quality of life [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 290
Study Start Date: July 2012
Estimated Study Completion Date: August 2022
Estimated Primary Completion Date: August 2021 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01649830

Contacts
Contact: Zhong-ping CHEN, MD, PhD +86-20-87343310 chenzhp@sysucc.org.cn
Contact: Ke SAI, MD, PhD +86-20-87343656 saike@sysucc.org.cn

Locations
China, Guangdong
Sun Yat-sen University Cancer Center Recruiting
Guangzhou, Guangdong, China, 510060
Principal Investigator: Zhong-ping CHEN, MD, PhD         
Sponsors and Collaborators
Sun Yat-sen University
Investigators
Principal Investigator: Zhong-ping CHEN, MD, PhD Sun Yat-sen University
  More Information

No publications provided

Responsible Party: Zhongping Chen, Professor and Chair, Department of Neurosurgery, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT01649830     History of Changes
Other Study ID Numbers: 2012012
Study First Received: July 20, 2012
Last Updated: August 2, 2014
Health Authority: China: Food and Drug Administration

Keywords provided by Sun Yat-sen University:
low-grade glioma
radiotherapy
chemotherapy

Additional relevant MeSH terms:
Astrocytoma
Glioma
Oligodendroglioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Temozolomide
Dacarbazine
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 25, 2014