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Concurrent chemoradiotherapy with adjuvant metronomic chemotherapy for high-grade gliomas: an open-label, multicenter, phase III randomized clinical trial

Concurrent chemoradiotherapy with adjuvant metronomic chemotherapy for high-grade gliomas: an open-label, multicenter, phase III randomized clinical trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400086602
Enrollment
Unknown
Registered
2024-07-08
Start date
2024-07-08
Completion date
Unknown
Last updated
2024-07-15

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

Conditions

High-grade glioma

Interventions

Metronomic chemotherapy group:Temozolomide was given orally at a dose of 75mg/m2/d on the first day of radiotherapy, followed by adjuvant chemotherapy at a dose of 50mg/m2/d on the first day of radiot
Conventional chemotherapy group:For mo thiazole amine capsule, the day 1 to begin radiation oral 75 mg/m2 / d, until the end of radiotherapy, 28 days rest, began to adjuvant chemotherapy, adjuvant che

Sponsors

Affiliated Cancer Hospital of Guizhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: (1) Histologically confirmed WHO II-IV gliomas and high-risk WHO II gliomas (with residual disease confirmed by imaging) without radiotherapy or chemotherapy; (2)KPS=70; (3) ECOG 2 or less; (4) Age of 18-70 years old, both sexes; ? White blood cell =4.00×10^9g/L, platelet =100×10^9g/L, hemoglobin =90g/L, total bilirubin, alanine aminotransferase, aspartate aminotransferase =1.5 times the upper limit of normal; (6) creatinine 1.5 times the upper limit of normal or less; (7) understand the study and have signed the informed consent;

Exclusion criteria

Exclusion criteria: (1) primary tumors underwent radiotherapy; (2) always had received a patients with vascular targeted therapy of epidermal growth factor; (3) during pregnancy or lactation. (4) serious lung or heart disease; (5) severe allergic history or specific constitution; (6) patients with personality or mental disorders, without or with limited capacity for civil conduct; (7) can't understand this experiment, rejection, or not to participate in the test of informed consent.

Design outcomes

Primary

MeasureTime frame
Grade 3-4 hematological toxicity;

Secondary

MeasureTime frame
OVerall survival;Progress-free survival;

Countries

China

Contacts

Public ContactFeng Jin

Affiliated Cancer Hospital of Guizhou Medical University

tjzlk2023@163.com+86 139 8512 4806

Outcome results

None listed

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