JPRN-jRCTs031180223
Recruiting
Phase 2
A phase 2 study of radio-chemotherapy for primary intracranial germ cell tumors - iGCT trial
Matsutani Masao0 sites210 target enrollmentMarch 8, 2019
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- primary intracranial germ cell tumors
- Sponsor
- Matsutani Masao
- Enrollment
- 210
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Not specified
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