Treatment of primary intracranial germ cell tumors

JRCT ID: jRCTs031180223

Registered date:08/03/2019

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: primary intracranial germ cell tumors
• Date of first enrollment: 07/01/2011
• Target sample size: 210
• Study type: Interventional

Intervention(s)

Germinoma group: Radiotherapy, 23.4Gy whole ventricle, and 3 cycles of CARE therapy (carboplatine 450mg/m2 + etoposide 150mg/m2 on days 1-3) every 4 weeks concomitantly.
Intermediate prognosis group: Radiotherapy, 23.4Gy whole ventricle and 27Gy local, and 3 cycles of CARE therapy concomitantly. If CR was not achieved, 3 cycles of ICE therapy (ifosfamide 900mg/m2 + cisplatin 20mg/m2 + etoposide 60mg/m2) will be added every 6 weeks.
Poor prognosis group: Radiotherapy, 30.6Gy local and 39.6Gy craniospinal, and a cycle of ICE therapy concomitantly. Additional adjuvant 7 cycles of ICE therapy will be added.

Outcome(s)

• Primary Outcome: 5 year progression free survival

Secondary Outcome

5 year overall survival
overall tumor response ratio
adverse events
Karnofsky performance status

Key inclusion & exclusion criteria

• Age minimum: >= 4age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Matsutani Masao
• Source(s) of Monetary Support: Gold Ribbon Network
• Secondary ID(s): UMIN000004528