Effect of Temozolomide after Radiation for Low-Grade Brain Tumors
Efficacy of Post-radiation Adjuvant Temozolomide Chemotherapy in Residue Low-grade Glioma
This study is testing if adding a chemotherapy drug called temozolomide to radiation treatment can help people with leftover low-grade brain tumors live longer without their cancer getting worse.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 290 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Sun Yat-sen University Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT01649830 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of combining radiotherapy with adjuvant temozolomide chemotherapy for patients with residual low-grade gliomas. It aims to determine if this combination improves progression-free survival compared to radiotherapy alone, while also assessing the impact on patients' quality of life. Participants will be randomly assigned to receive either the combined treatment or radiotherapy only. The study focuses on patients with incompletely resected WHO II astrocytoma, oligodendroglioma, or oligodendroastrocytoma.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 60 with incompletely resected low-grade gliomas and a Karnofsky Performance Score of 60 or higher.
Not a fit: Patients with prior treatment for their tumors, such as previous irradiation or chemotherapy, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve survival outcomes for patients with residual low-grade gliomas.
How similar studies have performed: Previous studies have shown that temozolomide is effective for high-grade gliomas, but this specific combination for low-grade gliomas is still being evaluated.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Guangzhou, Guangdong
- Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Principal investigator: Zhong-ping CHEN, MD, PhD — Sun Yat-sen University
- Study coordinator: Zhong-ping CHEN, MD, PhD
- Email: chenzhp@sysucc.org.cn
- Phone: +86-20-87343310
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.