A phase 2 study of radio-chemotherapy for primary intracranial germ cell tumors - iGCT trial

Matsutani Masao0 个研究点目标入组 210 人开始时间: 2019年3月8日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•1.Primary intracranial germ cell tumors excluding mature teratoma.
•2.Histologically-confirmed intracranial germ cell tumors. If HCG>=2,000IU/ml and/or AFP>=2,000ng/ml, histology can be omitted.
•3.The patient must not have any preceeding radiotherapy or chemotherapy.
•4.Age>=4.
•5.ECOG-PS of <3. PS=3 is allowed if the impairment is solely from neurological disturbance brought by tumors.
•6.Hematologic, renal, hepatic, and cardiac status should be documented within one week before registration.
•- White blood cell count >3,000 per mm3
•- Absolute neutrophil count > 1,500 per mm3
•- Platelets >80,000 per mm3
•- Hemoglobin >10.0 grams
•- AST and ALT < twice normal range
•- Bilirubin < 1.5mg/dl
•- Creatinine < 1.5mg/dl
•- BUN <25mg/dl
•- normal ECG
•7. Therapy must begin < four weeks after surgery.
•8. The patient must give written study-specific informed consent prior to study entry. If the patient is under 20 years old or the patient's mental status precludes his/her giving informed consent, written informed consent may be given by the responsible family member.
•9. Patients must have an estimated survival of at least 12 weeks.

•1. Previous malignancies.
•2. Major renal, bladder, infectious illnesses, interstitial pneumonitis or pulmonary fibrosis, ischemic heart diseases, liver cirrhosis, bleeding, uncontrolled DM, or psychiatric impairments which in the investigator's opinion will prevent administration or completion of the protocol therapy.
•3. Patients with known allergy to drugs used in the proposed regimens.
•4. Patients taking warfarin.
•5. patients pregnant or breast-feeding a baby.
•6. Patients, in the investigator's opinion, cannot complete the protocol study.

发起方

Matsutani Masao