Grade II/III Glioma Clinical Trial
Official title:
A Prospective Study of Concurrent Chemoradiotherapy With Temozolomide Versus Radiation Therapy Alone in Patients With IDH Wild-type/TERT Promoter Mutation Grade II/III Gliomas
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.
| Status | Recruiting |
| Enrollment | 30 |
| Est. completion date | December 2018 |
| Est. primary completion date | December 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 70 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| China | Beijing Tiantan Hospital | Beijing | Beijing |
| Lead Sponsor | Collaborator |
|---|---|
| Beijing Tiantan Hospital | Beijing Neurosurgical Institute, Beijing Shijitan Hospital |
China,
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| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Overall survival (OS) | Overall survival is defined as the time from randomization to death. | Up to 2 years | |
| Secondary | Progression free survival(PFS) | Progression free survival(PFS) is defined as the time from randomization to progressive disease or death. A combination of neurological examination and MRI brain scan used to define progression. | Up to 2 years | |
| Secondary | The incidence and severity of adverse events associated with treatment with RT alone and combined with temozolomide chemotherapy; according to the NCI Common Toxicity Criteria for Adverse Events (CTCAE), version 4.0. | Up to 2 years |