Postoperative treatment for newly diagnosed glioblastoma with temozolomide
A Phase III Study of Postoperative Early Temozolomide Treatment Plus STUPP Regimen for Newly Diagnosed GBM Multiforme
This study is testing if giving a chemotherapy drug called temozolomide right after surgery can help people with newly diagnosed glioblastoma live longer and feel better compared to the usual treatment.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 78 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Sun Yat-sen University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT05600491 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness and safety of administering early temozolomide chemotherapy following surgery for patients with newly diagnosed glioblastoma multiforme. Participants will receive the standard Stupp regimen in conjunction with early postoperative temozolomide treatment. The goal is to determine if this approach improves outcomes compared to traditional chemoradiotherapy. The study will involve patients aged 18 to 70 who have undergone significant tumor resection.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 70 with newly diagnosed glioblastoma who have undergone significant tumor resection.
Not a fit: Patients with recurrent gliomas, other malignancies, or contraindications to temozolomide may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve survival rates and quality of life for patients with glioblastoma.
How similar studies have performed: Previous studies have shown promising results with similar approaches, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Age: 18 years to 70 years; Newly diagnosed Glioblastoma in the supratentorial cerebral hemisphere; Gross total resection or large resection of \>70% in imaging studies; Eastern Cooperative Oncology Group performance status of 0-2; Adequate bone marrow, liver and renal function; Ability of subject to understand character and individual consequences of the clinical trial Written informed consent; anticipating survival ≥7 months. Exclusion Criteria: Refusal to participate the study; Current diagnosis or history of malignancies within the 3-year period preceding enrollment; Recurrent or multiple malignant gliomas, including gliomatosis cerebri, or metastatic extracalvarial or subtentorial lesions; Known hypersensitivity or contraindication to temozolomide; 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; Uncontrolled psychotic disorders or epilepsy.
Where this trial is running
Guangzhou, Guangdong
- Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Principal investigator: Mou Y Gao, MD, PhD — Department of Neurosurgery/Neuro-oncology, Sun Yat-sen University Cancer Center
- Study coordinator: Mou Y Gao, MD, PhD
- Email: Mouyg@sysucc.org.cn
- Phone: +86-20-87343821
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.