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Single-center, prospective, open, single-arm clinical study of radiotherapy combined with temozolomide for newly diagnosed adult supratentorial IDH mutation with CDKN2A/B deletion in grade 2/3 astrocytoma

Single-center, prospective, open, single-arm clinical study of radiotherapy combined with temozolomide for newly diagnosed adult supratentorial IDH mutation with CDKN2A/B deletion in grade 2/3 astrocytoma

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300068649
Enrollment
Unknown
Registered
2023-02-27
Start date
2023-02-27
Completion date
Unknown
Last updated
2023-05-22

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

Conditions

glioma

Interventions

Experimental group:60Gy radiotherapy combined with temozolomide synchronous and adjuvant chemotherapy

Sponsors

Beijing Tiantan Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. voluntarily participate in the study and sign the informed consent form. 2. age >=18 years, regardless of gender. 3. complete or near-total resection (>=90%) of newly diagnosed supratentorial tumors. 4. histologically confirmed grade 2 or 3 astrocytoma. 5. molecular pathology confirmed IDH mutation with CDKN2A/B deletion and no combined 1p/19q deletion. 6. synchronous radiotherapy was started within 8 weeks (= 100*109/L; absolute neutrophil count >= 1.5*10^9/L or white blood cell count >= 3.0*10^9/L; hemoglobin >= 90g/L; blood biochemistry: portal aminotransferase (AST) = 60. 9. subjects of childbearing potential are willing to use contraception during the study period.

Exclusion criteria

Exclusion criteria: 1. recurrence or intracranial or spinal metastases of glioma or other malignant tumors outside the center 2. have not undergone craniotomy for resection or the extent of resection has not reached major resection (<= 90%) 3. have received any previous antitumor treatment other than herbal therapy, including surgical treatment, chemotherapy (except temozolomide given postoperatively), radiotherapy, targeted drugs, immunotherapy, etc. 4. the presence of uncontrollable infection, uncontrollable epilepsy and/or hypertension and/or hyperglycemia 5. presence of human immunodeficiency virus (HIV) infection or active hepatitis B (HBsAg positive and HBV-DNA positive) infection or hepatitis C (HCV antibody positive) infection 6. active hemorrhage and/or inability to perform cranial CT or MRI prior to enrollment as detected by cranial CT or MRI scan 7. history of decompensated heart failure (NYHA class III and IV), unstable angina pectoris, acute myocardial infarction, persistent and clinically significant arrhythmia within three months prior to enrollment. 8. known hypersensitivity to temozolomide or its analogs or any component of the prescription 9. inability to cooperate with completion of radiotherapy. 10. other reasons, as judged by the investigator, for not being suitable for participation in this study.

Design outcomes

Primary

MeasureTime frame
Overall Survival;

Secondary

MeasureTime frame
Progression Free Survival;

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