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54Gy Radiation Therapy plus Concurrent and Adjuvant Temozolomide vs. Plus only adiuvant Temozolomide for High-risk Low-grade Gliomas With IDH Mutation/Without MGMT promoter methylation/Without1p/19q Co-deletion

54Gy Radiation Therapy plus Concurrent and Adjuvant Temozolomide vs. Plus only adiuvant Temozolomide for High-risk Low-grade Gliomas With IDH Mutation/Without MGMT promoter methylation/Without1p/19q Co-deletion

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000029356
Enrollment
Unknown
Registered
2020-01-26
Start date
2020-02-14
Completion date
Unknown
Last updated
2020-02-03

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

Conditions

Low grade glioma

Interventions

Experimental group:54Gy radiation plus concurrent and adjuvant TMZ chemotherapy
Control group:54Gy radiation plus adjuvant TMZ chemotherapy

Sponsors

Beijing Tiantan Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 75 years; 2. Karnofsky performance score =60 3. Patients with low-grade gliomas must also be considered "high risk" by exhibiting one of the following characteristics: Age >= 40 and any surgical therapy; Age < 40 with subtotal resection or biopsy 4. Histologically confirmed supratentorial Diffuse low-grade gliomas (World Health Organization grades II) 5. Tumor tissue must show IDH mutation and without 1p/19q Co-deletion and without MGMT promoter methylation 6. Neutrophilic granulocyte count =1.5x109/L,Platelet count =100 x109/L, Hemoglobin =100g/L 7. TBIL=1.5 times the lab's upper normal limit, AST or ALT < 1.5 times the lab's upper normal limit 8. Serum creatinine < 1.5 times the lab's upper normal limit 9. Adequate medical health to participate in this study 10.No previous systemic chemotherapy and radiotherapy to the brain 11.Written informed consent

Exclusion criteria

Exclusion criteria: 1. No pathological confirmation 2. Second cancer requiring radiotherapy or chemotherapy 3. Serious medical or neurological condition with a poor prognosis 4. Contraindications to radiotherapy or temozolomide chemotherapy 5. Patient unable to follow procedures, visits, examinations described in the study 6. Inability to undergo gadolinium-contrasted MRIs 7. Pregnant women or nursing mothers can not participate in the study 8. No suitalble for this study confirmed by researchers

Design outcomes

Secondary

MeasureTime frame
Free progression survival;Tematologic toxicity;—

Primary

MeasureTime frame
Overall survival;Health-related quality of life;—

Countries

China

Contacts

Public ContactXiaoguang Qiu

Beijing Tiantan Hospital, Capital Medical University

qiuxiaoguang@bjtth.org+86 010-59975580

Outcome results

None listed

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