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High-Dose or low-Dose Radiation Therapy With Concurrent and Adjuvant Temozolomide for High-risk Low-grade Gliomas With IDH Mutation and 1p/19q Co-deletion and/or MGMT promoter methylation

High-Dose or low-Dose Radiation Therapy With Concurrent and Adjuvant Temozolomide for High-risk Low-grade Gliomas With IDH Mutation and 1p/19q Co-deletion and/or MGMT promoter methylation

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000029334
Enrollment
Unknown
Registered
2020-01-25
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 gliomas

Interventions

High dose group:54Gy radiation
Low dose group:45Gy radiation

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 =100 x10^9/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. Not suitable for this study who to be confirmed by researchers.

Design outcomes

Primary

MeasureTime frame
Overall Survival;Health-related quality of life;

Secondary

MeasureTime frame
Free Progression Survival;Hematologic Toxicity;

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