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

NCT01649830 | Recruiting Phase 3 DMC

• 1 other identifier: 2012012
• Study Type: interventional
• Target: 290
• Locations: 1 country
• Sites: 1

Brief Summary

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

Astrocytoma; Oligodendroglioma; Oligodendroastrocytoma

Keywords

low-grade glioma; radiotherapy; chemotherapy

Outcome Measures

Primary Outcomes (1)

• Progression-free survival

  5 years

Secondary Outcomes (1)

• Quality of life

  5 years

Study Arms (2)

Radiotherapy plus adjuvant temozolomide

EXPERIMENTAL

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; Drug: Temozolomide

Radiotherapy

ACTIVE COMPARATOR

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

Interventions

Radiotherapy RADIATION

External beam radiation: 54.0 Gy in 27 - 30 fractions over 6 - 7 weeks.

Radiotherapy; Radiotherapy plus adjuvant temozolomide

Temozolomide DRUG

dosed at 200 mg/m2 (150 mg/m2 for the first cycle) daily for 5 consecutive days, repeated every 28 days.

Radiotherapy plus adjuvant temozolomide

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

MeSH Terms

Conditions

Astrocytoma; Oligodendroglioma

Interventions

Radiotherapy; Temozolomide

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapeutics; Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Zhong-ping CHEN, MD, PhD

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhong-ping CHEN, MD, PhD

CONTACT

+86-20-87343310; chenzhp@sysucc.org.cn

Ke SAI, MD, PhD

CONTACT

+86-20-87343656; saike@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chair, Department of Neurosurgery

Study Record Dates

• First Submitted: July 20, 2012
• First Posted: July 25, 2012
• Study Start: July 1, 2012
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2026
• Last Updated: May 28, 2020

Record last verified: 2020-05

Locations

CN (1)