Oligodendroglioma Oligodendroglioma
Conditions
Interventions
For patients in whom oligodendroglioma is suspected based on imaging findings and other clinical information,
1, Biopsy or partial resection will be performed to confirm the diagnosis of oligodendrog
Neoadjuvant chemotherapy
Sponsors
Kitamura Yohei
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1, Age 20 to 60 years at the time of registration. 2, Patients with a suspected oligodendroglioma based on age and preoperative CT/MRI and other clinical findings at initial presentation, or patients with progressive oligodendroglioma who were observed without further treatment after the first surgery (any grade). 3, Judged by the participating institution to be eligible for 90 percent or more resection with standard surgical resection. 4, Maximum tumor diameter on axial MRI FLAIR is 25 mm or more. Exception: Tumors less than 25 mm may be allowed if considered a good indication for this protocol (for example, infiltration into eloquent areas), after discussion among the PI, secretariat, and co-investigators; limited to up to 2 cases. 5, ECOG Performance Status 0 to 1. 6, No prior chemotherapy or radiotherapy for an intracranial tumor. 7, Laboratory tests performed within 14 days prior to registration must meet all of the following criteria (retesting allowed once): ANC 1500 per mm3 or higher Hemoglobin 9.0 g/dL or higher Platelets 100000 per mm3 or higher AST no more than 3 times the upper limit of normal ALT no more than 3 times the upper limit of normal Total bilirubin 2.0 mg/dL or lower Serum creatinine 1.5 mg/dL or lower ECG: no clinically significant abnormality Pulmonary function: SpO2 92 percent or higher on room air 8, Written informed consent for protocol treatment and scheduled follow-up for 5 years after registration. 9, Secondary registration: Patients primarily registered who are confirmed to have oligodendroglioma based on pathology and molecular diagnosis from the first surgery (biopsy or partial resection).
Exclusion criteria
Exclusion criteria: 1, Patients with other active malignancies. Exceptions include completely resected basal cell carcinoma, stage 1 squamous cell carcinoma, carcinoma in situ, intramucosal carcinoma, superficial bladder cancer, or other cancers with no recurrence for 5 years or longer. 2, Patients with active autoimmune disease or a history of chronic or recurrent autoimmune disease. 3, Patients with uncontrolled hypertension despite appropriate treatment, for example systolic blood pressure 150 mmHg or higher or diastolic blood pressure 90 mmHg or higher persisting for 24 hours or longer. 4, Patients with hereditary bleeding diathesis or clinically significant coagulopathy associated with bleeding risk, excluding therapeutic anticoagulation. 5, Patients receiving therapeutic anticoagulation, excluding prophylactic use, or who received such treatment within 10 days prior to registration and are judged by the investigator to be at significant risk of bleeding. 6, Patients with serious non healing wounds, active ulcers, or untreated fractures. 7, Patients with a history of active gastrointestinal bleeding within 180 days prior to registration. 8, Patients with a history within 180 days prior to registration of CTCAE grade 2 or higher cerebral infarction requiring treatment, or arterial or venous thromboembolism including pulmonary embolism or deep vein thrombosis. 9, Patients with uncontrolled or clinically significant cardiovascular disease. 10, Patients with uncontrolled diabetes mellitus. 11, Patients with active infection requiring systemic intravenous therapy. 12, Patients with pulmonary fibrosis or interstitial lung disease. 13, Patients currently participating in another clinical trial. 14, Patients receiving immunosuppressive therapy. 15, Patients receiving systemic corticosteroid therapy. Short term use for anaphylaxis prevention or topical or local use such as skin or airway is permitted. 16, Patients unable or unwilling to undergo MRI or contrast enhanced MRI due to pacemaker, implantable cardioverter defibrillator, contrast allergy, or other reasons. Patients who can undergo contrast MRI with prophylactic corticosteroid administration may be eligible. 17, Pregnant or breastfeeding women, or women of childbearing potential. 18, Patients deemed incapable of providing informed consent due to dementia or other cognitive impairment. 19, Patients who do not provide written informed consent. 20, Any other condition that, in the investigator's judgment, makes the patient unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 5-year progression-free survival (5y-PFS). PFS is defined as the time from primary registration to disease progression or death from any cause, assessed according to the RANO 2.0 criteria. The evaluation period is 5 years after registration. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1, 5-year progression-free survival in patients without residual FLAIR lesions after second surgery. 2, 5-year overall survival (OS). 3, Time to next treatment (TTNT). 4, Safety, defined as the incidence of Grade 3 or higher adverse events according to CTCAE v5.0. 5, Completion rate of the second surgery. 6, Gross total resection rate. 7, Tumor reduction rate following neoadjuvant chemotherapy based on FLAIR imaging. 8, Completion rate of neoadjuvant chemotherapy (number of cycles administered). 9, Cognitive function assessment using the Mini-Mental State Examination (MMSE). 10, Integrated analysis of PFS and OS with historical cohort (Study 20050002). | — |
Contacts
Public ContactHikaru Sasaki
International University of Health and Walfare Ichikawa General Hospital
Outcome results
None listed