Temozolomide as monotherapy for elderly and temozolomide sensitive glioblastoma

JRCT ID: jRCTs031200438

Registered date:24/03/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: glioblastoma
• Date of first enrollment: 24/03/2021
• Target sample size: 5
• Study type: Interventional
• Intervention(s): Temozolomide 5days on/23 days off. maximum 12 cycles.

Outcome(s)

• Primary Outcome: Overall survival
• Secondary Outcome: progression free survival, overall response rate, aadverse events, QOL, cognitive function

Key inclusion & exclusion criteria

• Age minimum: >= 71age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. Newly diagnosed histologically and genetically confirmed glioblastoma.
2. Registration should be completed by 28 days after surgery.
3. MGMT methylated.
4. Drug sensitivity assay indicating temozolomide sensitive.
5. More than 71 years old and KPS 50.
6. Adequate organ function indicated by all of the following.
1)neutrophil count more than 1,500/mm3
2)Platelet count more than100 thousands
3)AST, ALT less than 100IU/L
4)Total bilirubin less than 1.5mg/dL
5).Serum creatinine less than 1.5mg/dL
7. Regardless of the presence of mesurable lesions.
8. Written informed consent

Exclude criteria

1. Active infection, or critical status for treatment.
2. Multiple primary cancers with disease-free period less than 5
years, except carcinoma in situ or intra mucosal disease cured
by local therapy.
3. Known hypersensitivity to temozolomide.
4. Patients with active hepatic disease.
5. Carmustine wafer (Gliadel).
6. Any prior chemotherapy, radiotherapy.
7. Attending physician has determined unsuitable to participate in the study.

Related Information

• Primary Sponsor: Tateishi Kensuke