IDH wild-type glioma (grade III) (anaplastic astrocytoma) Glioma
Conditions
Interventions
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Sponsors
Tanaka Shota
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: At the time of enrollment, patients will be included if they meet all of the following criteria. 1) Diagnosis of IDH wild-type glioma (grade III) (anaplastic astrocytoma) *after tumor resection or biopsy. *According to the WHO Classification of Brain Tumors, Fourth Revision (2016) 2) No history of surgical treatment for glioma (first case), except for resection or biopsy. However, if a second surgery (excision) is performed on the residual lesion within 28 days of the first surgery (excision or biopsy), the patient is eligible. 3) Implantation of carmustine intracerebroventricularly at the time of surgery is acceptable. 4) Preoperative contrast-enhanced MRI of the head shows tumor only supratentorial (not in the brainstem or cerebellum). 5) No evidence of disseminated lesions on contrast-enhanced MRI of the head prior to enrollment. 6) Can be registered regardless of the presence or absence of measurable lesions prior to enrollment. 7) Radiation therapy with temozolomide (TMZ) is the initial treatment. Radiotherapy is administered for more than 50 Gy in the initial treatment and TMZ in combination with radiotherapy is administered for more than 30 days. 8) Within 49 days of the last day of radiation therapy with TMZ 9) Age 18 years or older on the date consent is obtained. 10)Karnofsky performance status (KPS) more than equal 70 11) No prior chemotherapy or radiation therapy for other types of cancer. However, prior endocrine therapy (hormone therapy for breast cancer, hormone therapy for prostate cancer) is eligible. 12) All of the following conditions are met. All laboratory tests should be the most recent within 14 days before registration. (1) Neutrophil Counts>=1,500 /mm3 (2) Hemoglobin>=8.0 g/dL (3) Platelet Counts>=10 *10,000/mm3 (4)AST(GOT)<=120 U/L (5)ALT(GPT)<=120 U/L (6)Creatinine<=1.5 mg/dL 13) Expected to survive at least 12 weeks from the date of registration 14) Can use effective contraceptive methods (if of childbearing age) 15) The patient's free written consent to participate in this clinical trial has been obtained after receiving a full explanation of the study (no surrogate consent is acceptable).
Exclusion criteria
Exclusion criteria: Any of the following conditions shall not apply 1) Have active overlapping cancers(Simultaneous overlapping/multiple cancers and iatrogenic overlapping/multiple cancers with a disease-free interval of 5 years or less. However, carcinoma in situ (intraepithelial carcinoma) and intramucosal carcinoma equivalent lesions that are considered curable by local treatment are not included in active multiple/multiple cancers.) 2) Has an infection requiring systemic treatment 3) Complicated infectious meningitis requiring treatment 4) Fever greater than 38 degree Celsius at axillary temperature at the time of registration 5) Delayed wound healing after excision or biopsy 6) Patients with implanted medical devices that are contraindicated, such as pacemakers, defibrillators, or deep brain stimulators 7) Pregnant, possibly pregnant, or breastfeeding women 8) Psychosis or psychiatric comorbidities that would make participation in the study difficult 9) Receiving continuous systemic administration (oral or intravenous) of steroids or other immunosuppressive agents for diseases other than brain tumors. Steroids for brain tumors are acceptable 10) Complicated unstable angina (angina with onset or worsening of attacks within 3 weeks prior to enrollment), or history of myocardial infarction within 6 months 11) Pulmonary fibrosis, interstitial pneumonia, or severe emphysema as diagnosed by chest x-ray, or with one or more of the following 12) Gadolinium is not available due to drug allergy 13) HIV antibody is positive 14) HBs antigen is positive 15) Participating in another clinical trial 16) Other conditions that the investigator or subinvestigator considers inappropriate for participation in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival (PFS) as determined by central review | — |
Secondary
| Measure | Time frame |
|---|---|
| [Efficacy Endpoints] 1) Progression-free survival (PFS) as determined by the attending physician 2) Overall survival, OS 3) Progression-free survival at 6 and 12 months (PFS6 PFS12) as determined by central/ the attending physician 4) 1- and 2-year survival rates 5) Treatment response rate on imaging (Response assessment in neuro-oncology) as determined by central/ the attending physician 6) QOL Assessment (EORTC QLQ-C30 BN20) [Safety Endpoints] Occurrence, severity and frequency of adverse events(CTCAE ver5.0) | — |
Contacts
Public ContactShunsaku Takayanagi
Saitama Medical University International Medical Center.
Outcome results
None listed