JCCG CNSGCT2021: A Randomized Controlled Clinical Study in Patients with Central Nervous System Germ Cell Tumor

Phase 3

Recruiting

• Conditions: Central Nervous System Germ Cell Tumor

• Registration Number: JPRN-jRCTs051220066
• Lead Sponsor: ARAKAWA Yoshiki

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-07-22
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 380

Inclusion Criteria

Registration criteria
1) Diagnosed as newly diagnosed central nervous system germ cell tumor in pathological diagnosis, or clinically proven diagnosis of central nervous system germ cell tumor.
2) Registered in the observational study for pediatric solid tumors by Japan Children's Oncology Group (JCCG).
3) Any age
4) No prior chemotherapy or head radiation therapy for any intracranial tumors.
5) Written informed consent is obtained from the patient or his/her legal guardian.

Germinoma stratum
1) Diagnosed as germinoma in pathological diagnosis.
2) 3 years or older, less than 30 years.
3) Serum alpha-fetoprotein (AFP)<10 ng/mL and human chorionic gonadotropin (HCG)<200mIU/ml.
4) No spinal dissemination.
5) Protocol treatment can be started within 6 weeks after surgery .
6) ECOG performance status (PS) of 0, 1, 2, or 3 due to neurological signs caused by the tumor.
7) The following conditions are met within 14 days prior to registration.
1. WBC>=2000/microliter and neutrophil >=1000/microliter
2. PLT>=100,000/microliter
3. AST<=100IU/L
4. D-Bil<=1.0mg/dl
5. Serum creatinine level is below the upper limit of normal value

Malignant germ cell tumor stratum
1) Diagnosed as malignant germ cell tumor (yalk sac tumor, embryonal carcinoma, choriocarcinoma) in pathological diagnosis or mixed with malignant germ cell tumor or clinically diagnosed as malignant germ cell tumor with serum AFP>=250 ng/mL or HCG >=500mIU/ml.
2) 3 years or older, less than 30 years.
3) No multiple tumors.
4) No dissemination.
5) Protocol treatment can be started within 6 weeks after surgery or cllinial diagnosis.
6) ECOG performance status (PS) of 0, 1, 2, or 3 due to neurological signs caused by the tumor.
7) The following conditions are met within 14 days prior to registration
1. WBC>=2000/microliter and neutrophil >=1000/microliter
2. PLT>=100,000/microliter
3. AST<=100IU/L
4. D-Bil<=1.0mg/dl
5. Serum creatinine level is below the upper limit of normal value

Prospective observation stratum
1) Diagnosed pathologically or clinically diagnosed as germ cell tumor except for germinoma stratum and malignant germ cell tumor stratum
2) At any age
3) Regardless of tumor location, number, and dissemination

Exclusion Criteria

Germinoma stratum and malignant germ cell tumor stratum
1) Active double cancer (synchronous double cancer and metachronous double cancer with disease-free period of 5 years or less).
2) Complicated with extracranial metastasis.
3) Complicated heart disease requiring treatment.
4) Pregnant or nursing.

Prospective observation stratum
1) Judgement of inappropriate inclusion by physician

Study & Design

• Study Type: Interventional
• Study Design: Not specified