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Clinical research for the treatment of IDH wild-type glioblastoma by conbination of simultaneous integrated boosts radiotherapy and concurrent adjuvant temozolomide chemotherapy

Clinical research for the treatment of IDH wild-type glioblastoma by conbination of simultaneous integrated boosts radiotherapy and concurrent adjuvant temozolomide chemotherapy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000028768
Enrollment
Unknown
Registered
2020-01-03
Start date
2020-01-01
Completion date
Unknown
Last updated
2020-01-06

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

Conditions

Glioblastoma

Interventions

Experimental group:simultaneous integrated boosts radiotherapy PTV1 60Gy/30F
PTV2 66Gy/30F and concurrent adjuvant temozolomide chemotherapy
Control group:Standard radiotherapy PTV 60Gy/30F and concurrent adjuvant temozolomide chemotherapy

Sponsors

Department of Oncology, Xiangya Hospital, Central South University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. According to the 2016 WHO classification of central nervous system tumors ,Postoperative patients diagnosed as glioblastoma by histopathology and reported as IDH wild-type by molecular pathology; 2. Aged 18-65 years; 3. Patients who have not been treated with radiotherapy or chemotherapy previously; 4. No history of other malignancies; 5. Liver function: Total bilirubin =80 ml/min; 7. Blood test: Absolute neutrophil count (ANC) >=2x10^9/L, platelet count >=100x10^9/L and hemoglobin >=9g/dL; 8. No serious heart, lung and other important organ dysfunction; 9. KPS score >=80; 10. Signed Informed consent.

Exclusion criteria

Exclusion criteria: 1. Have been treated with anti-tumor therapy, including chemotherapy and radiotherapy; 2. Women in pregnancy or lactation; 3. Patients not cooperating with regular follow-up due to psychological, social, family and geographic reasons; 4. Known to be allergic to chemotherapeutic drugs that may be used; 5. With a severe uncontrolled infection or medical illness; 6. Major organ dysfunction, such as decompensated heart, lung, kidney, liver failure, can not tolerate radiotherapy and chemotherapy; 7. Laboratory examination: Total bilirubin > normal value upper limit (ULN), AST and/or ALT > 1.5 times normal value upper limit (ULN) and accompanied by alkaline phosphatase 2.5 times times normal value upper limit (ULN); 8. Has the fator to influence the medicine, the distribution, the metabolism, the excretion, such as the central nervous system abnormality, the chronic diarrhea, the ascites, the chest water and so on; 9. Long-term use of immunosuppressive agents after organ transplantation; 10. With history of other malignancies.

Design outcomes

Primary

MeasureTime frame
progression free survival;objective response rate;

Secondary

MeasureTime frame
overall survival;

Countries

China

Contacts

Public ContactJidong Hong

Department of Oncology, Xiangya Hospital, Central South University

hongjidong1966@126.com+86 13808485101

Outcome results

None listed

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