CCRT With Temozolomide Versus RT Alone in Patients With IDH Wild-type/TERT Promoter Mutation Grade II/III Gliomas

• Status: Unknown status
• Trial end date: 2018-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The management of lower-grade gliomas (Diffuse low-grade and intermediate-grade gliomas, WHO II and III) is largely based on surgery followed by radiotherapy. Recent studies showed that lower-grade glioma patients with IDH wild-type (IDH-wt) and TERT promoter mutation (TERTp-mut) had dismal clinical outcomes. These results suggested that current treatment strategies are not adequate for this subtype of lower-grade glioma.

The present study aims to examine the efficacy and safety of concurrent chemoradiotherapy with temozolomide followed by adjuvant temozolomide for lower- grade glioma patients with IDH-wt and TERTp-mut.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Beijing Tiantan Hospital
• Collaborators: Beijing Neurosurgical Institute; Beijing Shijitan Hospital; Beijing Shijitan Hospital, Capital Medical University
• Treatments: Dacarbazine; Temozolomide

Criteria

Inclusion Criteria:

• Histologically confirmed supratentorial Diffuse low-grade and intermediate-grade gliomas (World Health Organization grades II and III )

• IDH wild-type and TERT promoter mutation

• Age > 18

• Karnofsky performance score > 60

• Neutrophilic granulocyte count > 1500/µl

• Platelet count > 100 000/µl

• Hemoglobin > 10 g/dl

• Serum creatinine < 1.5 times the lab's upper normal limit

• AST or ALT < 1.5 times the lab's upper normal limit

• Adequate medical health to participate in this study

• No previous systemic chemotherapy

• No previous radiotherapy to the brain

• Written informed consent

Exclusion Criteria:

• Serious medical or neurological condition with a poor prognosis

• Contraindications to radiotherapy or temozolomide chemotherapy

• Patient unable to follow procedures, visits, examinations described in the study

• Second cancer requiring radiotherapy or chemotherapy

• Inability to undergo gadolinium-contrasted MRIs

• Pregnant women or nursing mothers can not participate in the study