Phase II study of intensive chemotherapy in treating pediatric patients with newly diagnosed cranial nongerminomaous germ cell tumor

Phase II study of intensive chemotherapy in treating pediatric patients with newly diagnosed cranial nongerminomaous germ cell tumor - Intensive chemotherapy in treating pediatric patients with cranial nongerminomaous germ cell tumor

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000002398

Enrollment

Registered

2009-08-28

Start date

2009-08-01

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

Cranial nongerminomatous germ cell tumor

Interventions

Patients receive chemotherapy consisting of cyclophosphamide, etoposide, cisplatin. Chemotherapy repeats every 4 weeks for 5 courses. Radiation doses are 50 Gy to the primary site. High-risk patients

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Diagnosis of germ cell tumor, and 2-a) or b). 2-a) AFP > upper limit of normal or beta hCG > 50 ng/ml. 2-b) The element of yolk sac tumor, choriocarcinoma, or embryonal carcinoma is contained in the tissue. 3. Has undergone biopsy within the past 42 days. 4. No prior radiation therapy or chemotherapy. 5. PS score: 0-3. 6. WBC >2000/mm3, ANC >1000/mm3, Platelet count >100000/mm3 7. ALT <100 IU/ml, Billirubin <1.5 mg/dl, Serum creatinine < upper limit of normal. 8. Normal electorocardiogram.

Exclusion criteria

Exclusion criteria: Has double cancer. Has cardiac disease for which treatment is necessary.

Design outcomes

Primary

Measure	Time frame
3-year progression-free survival	—

Secondary

Measure	Time frame
3-year overall survival	—

Countries

Japan

Contacts

Public ContactKeiko Okada

Osaka City General Hospital Pediatric Hematology/Oncology

Outcome results

None listed

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