Treatment of primary intracranial germ cell tumors

Phase 2

Recruiting

• Conditions: primary intracranial germ cell tumors; D009373

• Registration Number: JPRN-jRCTs031180223
• Lead Sponsor: Matsutani Masao

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-08
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 210

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
- 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.

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
5 year progression free survival

Secondary Outcome Measures

Name	Time	Method
5 year overall survival<br>overall tumor response ratio<br>adverse events<br>Karnofsky performance status