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

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

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000004528

Enrollment

210

Registered

2010-12-15

Start date

2010-12-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

primary intracranial germ cell tumors

Interventions

surgery radiotherapy chemotherapy

Eligibility

Sex/Gender

All

Inclusion 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 - 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

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.

Design outcomes

Primary

Measure	Time frame
5-year progression-free survival	—

Secondary

Measure	Time frame
5-year overall survival, response rates, adverse events	—

Countries

Japan

Contacts

Public ContactRyo Nishikawa

International Medical Center, Saitama Medical University Dept. of Neurosurgery/Neuro-oncology

rnishika@saitama-med.ac.jp042-984-4111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026