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

Primary Purpose

Astrocytoma, Oligodendroglioma, Oligodendroastrocytoma

Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Radiotherapy
Temozolomide
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Astrocytoma focused on measuring low-grade glioma, radiotherapy, chemotherapy

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sun Yat-sen University Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Radiotherapy plus adjuvant temozolomide

Radiotherapy

Arm Description

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 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.

Outcomes

Primary Outcome Measures

Progression-free survival

Secondary Outcome Measures

Quality of life

Full Information

First Posted
July 20, 2012
Last Updated
May 26, 2020
Sponsor
Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT01649830
Brief Title
Efficacy of Post-radiation Adjuvant Temozolomide Chemotherapy in Residue Low-grade Glioma
Official Title
Efficacy of Post-radiation Adjuvant Temozolomide Chemotherapy in Residue Low-grade Glioma
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Recruiting
Study Start Date
July 2012 (undefined)
Primary Completion Date
August 2025 (Anticipated)
Study Completion Date
August 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Astrocytoma, Oligodendroglioma, Oligodendroastrocytoma
Keywords
low-grade glioma, radiotherapy, chemotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
290 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Radiotherapy plus adjuvant temozolomide
Arm Type
Experimental
Arm Description
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.
Arm Title
Radiotherapy
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Radiation
Intervention Name(s)
Radiotherapy
Intervention Description
External beam radiation: 54.0 Gy in 27 - 30 fractions over 6 - 7 weeks.
Intervention Type
Drug
Intervention Name(s)
Temozolomide
Intervention Description
dosed at 200 mg/m2 (150 mg/m2 for the first cycle) daily for 5 consecutive days, repeated every 28 days.
Primary Outcome Measure Information:
Title
Progression-free survival
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Quality of life
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhong-ping CHEN, MD, PhD
Phone
+86-20-87343310
Email
chenzhp@sysucc.org.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Ke SAI, MD, PhD
Phone
+86-20-87343656
Email
saike@sysucc.org.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhong-ping CHEN, MD, PhD
Organizational Affiliation
Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sun Yat-sen University Cancer Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhong-ping CHEN, MD, PhD

12. IPD Sharing Statement

Learn more about this trial

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

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