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Clinical observation on the treatment of high-risk low-grade glioma by combination of temozolomide chemotherapy and IMRT

Clinical observation on the treatment of high-risk low-grade glioma by combination of temozolomide chemotherapy and IMRT

Status
Recruiting
Phases
Phase 3
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1800017799
Enrollment
Unknown
Registered
2018-08-15
Start date
2018-09-01
Completion date
Unknown
Last updated
2018-11-05

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

Conditions

Low-grade glioma

Interventions

Radiotherapy alone group:IMRT (54Gy/30f)
Radiotherapy combined with temozolomide concurrent and adjuvant chemotherapy group:IMRT (54Gy/30f)+ temozolomide concurrent chemotherapy + temozolomide adjuvant chemotherapy

Sponsors

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

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Incomplete High-risk low-grade gliomas after incomplete resection, or IDH wild-type, or = 3 risk factors (age =40y, stellate origin, bilateral hemispheres, diameter > 6cm, preoperative neurological deficit > 1non-1p19q deletion) (WHO Level II) patients; 2. Patients who have not been treated with radiotherapy or chemotherapy previously; 3. Male or female aged 18-60 years; 4. Liver function: Total bilirubin = normal value upper limit (ULN), AST and alt = 2.5 times normal value upper limit (ULN), alkaline phosphatase = 5 times times normal value upper limit (ULN); 5. Renal function: Creatinine clearance rate =80 ml/min; 6. Blood test: Absolute neutrophil count (ANC) =2x10^9/L, platelet count =100x10^9/L and hemoglobin =9g/dl; 7. KPS score =80; 8. 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. There is a history of other malignant tumors before the study. 11. Patients with targeted drug therapy; 12. With history of other malignancies; 13. With serious heart, lung and other important organ dysfunction.

Design outcomes

Primary

MeasureTime frame
progression survival rate;

Secondary

MeasureTime frame
overall survival;objective response rate;

Countries

China

Contacts

Public ContactLiangfang Shen

Department of Oncology, Xiangya Hospital, Central South University

slf1688@sina.com+86 13975805137

Outcome results

None listed

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