NCT01649830 Efficacy of Post-radiation Adjuvant Temozolomide Chemotherapy in Residue Low-grade Glioma
| NCT ID | NCT01649830 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Sun Yat-sen University |
| Condition | Astrocytoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 290 participants |
| Start Date | 2012-07 |
| Primary Completion | 2025-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 290 participants in total. It began in 2012-07 with a primary completion date of 2025-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Zhong-ping CHEN, MD, PhD
PRINCIPAL INVESTIGATOR
Sun Yat-sen University
Frequently Asked Questions
Who can join the NCT01649830 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 60 Years, studying Astrocytoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT01649830 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 290 participants.
Is NCT01649830 currently recruiting?
Yes, NCT01649830 is actively recruiting participants. Contact the research team at chenzhp@sysucc.org.cn for enrollment information.
Where is the NCT01649830 trial being conducted?
This trial is being conducted at Guangzhou, China.
Who is sponsoring the NCT01649830 clinical trial?
NCT01649830 is sponsored by Sun Yat-sen University. The principal investigator is Zhong-ping CHEN, MD, PhD at Sun Yat-sen University. The trial plans to enroll 290 participants.