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A Phase II Trial on Temozolomide Alternating Weekly Regimen with delay radiotherapy in Newly Diagnosed glioblastoma

A Phase II Trial on Temozolomide Alternating Weekly Regimen with delay radiotherapy in Newly Diagnosed glioblastoma

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900027057
Enrollment
Unknown
Registered
2019-10-30
Start date
2019-01-01
Completion date
Unknown
Last updated
2019-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

glioblastoma

Interventions

exprimental group:Oral TMZ 150mg/(m^2.d), d1-7, d15-21, repeat treatment course every 28 days, 8 treatment courses included total.
Control group:Concurrent chemoradio therapy: radiotherapy is synchronized with oral TMZ 75mg/(m^2.d) for 6 weeks
Then 6 courses of TMZ adjuvant chemotherapy: the initial dose of TMZ is 150mg/(m^2.d), d1-5, the first course is 28d
if patient is well tolerated, the second course increased to TMZ 200mg/(m^2.d), d1-5, a course

Sponsors

3rd Affiliated Hospital of Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. diagnosed as WHO IV glioblastoma by histopathology after operation; 2. Aged 18 years to 75 years; 3. Karnofsky Performance Score >=60; 4. Anticipating survival >=2 months; 5. The patients have no dysfunction of major organs, with normal liver and kidney functions were normal. The specific test indexes required: white blood cell>1.5x10^9/L, platelet>100x10^9/L, hemoglobin>10g/dl, and the serum bilirubin was 1.5 times lower than the maximum normal value.ALT and AST were less than 2 times of the maximum normal value. Serum creatinine <=1.5mg/dl.

Exclusion criteria

Exclusion criteria: 1. Pregnant or lactating patients 2. Patiens with purulent and chronic infected wounds 3. Patients with liver, kidney and heart insufficiency 4. Uncontrolled psychotic disorders or epilepsy 5. Patients are not suitable to participate the study consider by investigator

Design outcomes

Primary

MeasureTime frame
overall survival;

Secondary

MeasureTime frame
progression-free survival;quality of life;

Countries

China

Contacts

Public ContactChaofeng Liang

3rd Affiliated Hospital of Sun Yat-sen University

liangchf5@mail.sysu.edu.cn+86 020-85252170

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026