Efficacy of Post-radiation Adjuvant Temozolomide Chemotherapy in Residue Low-grade Glioma
This study is currently recruiting participants.
Verified July 2012 by Sun Yat-sen University
Sponsor:
Sun Yat-sen University
Information provided by (Responsible Party):
Zhongping Chen, Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT01649830
First received: July 20, 2012
Last updated: July 24, 2012
Last verified: July 2012
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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: | 350 |
| 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
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: | July 24, 2012 |
| 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 Adjuvants, Immunologic |
Temozolomide Dacarbazine Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 22, 2013