Phase II study of multimodality treatment for ATRT

Phase II study to evaluate the efficacy and safety of the multimodality therapy for atypical teratoid rhabdoid tumors with the intensified chemotherapy via intrathecal therapy and subsequent high-dose chemotherapy comprising thiotepa and melphalan and following delayed irradiation - JCCG AT20

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs051200071

Enrollment

Registered

2020-10-22

Start date

2020-10-27

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

Atypical teratoid rhabdoid tumor Atypical teratoid rhabdoid tumor

Interventions

Multimodality treatment will be provided for each risk group as a recommended regimen. Standard risk group (M0-1): 6 courses of multi-agent chemotherapy including intrathecal chemotherapy followed by

D017427

multimodality treatment

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Locally diagnosed as atypical teratoid rhabdoid tumor (ATRT) after tumor resection or biopsy. 2) Registered in an observational study for pediatric solid tumors by Japan Children's Oncology Group (JCCG). 3) A sample for a central diagnosis has been submitted or is scheduled to be submitted. 4) Protocol treatment can be started within 6 weeks after surgery 5) Less than 21 years 6) No prior radiation therapy or chemotherapy 7) ECOG Performance Status (PS) is 3 or less 8) The following conditions are met within 14 days prior to registration 1. WBC>=2000/maicroL 2. PLT>=100,000/maicroL 3. AST<=100IU/L 4. D-Bil<=1.0mg/dl 5. Serum creatinine level is below the upper limit of normal value 9) Written informed consent is obtained from the patient or his/her legal guardian.

Exclusion criteria

Exclusion criteria: 1) Active double cancer (synchronous double cancer and metachronous double cancer with disease-free period of 5 years or less). 2) Presence of extracranial metastasis (M4) or extracranial rhabdoid tumor. 3) Complicated heart disease requiring treatment. 4) You are pregnant or nursing. 5) Ddeemed inappropriate at the discretion of the attending physician.

Design outcomes

Primary

Measure	Time frame
3-year progression free survival (3yr-PFS)	—

Secondary

Measure	Time frame
Efficacy evaluation 1. 3-year and 5year overall survival 2. 5-year progression-free survival 3. Response rate 4. Tumor location at the onset and relapse 5. The proportion of 2nd look surgery 6. Site of recurrence 7. Response rate with topotecan window (M2-3 only) 8. Recurrence/progression rate during treatment Safety evaluation 1. Rate of the adverse event as CTCAE Grade 3 or higher. 2. Periods from surgery to the initiation of protocol treatment 3. Rate of completion of protocol treatment and rate of leukoencephalopathy 4. Rate of late complication	—

Measure

Time frame

Efficacy evaluation 1. 3-year and 5year overall survival 2. 5-year progression-free survival 3. Response rate 4. Tumor location at the onset and relapse 5. The proportion of 2nd look surgery 6. Site of recurrence 7. Response rate with topotecan window (M2-3 only) 8. Recurrence/progression rate during treatment Safety evaluation 1. Rate of the adverse event as CTCAE Grade 3 or higher. 2. Periods from surgery to the initiation of protocol treatment 3. Rate of completion of protocol treatment and rate of leukoencephalopathy 4. Rate of late complication

—

Contacts

Public ContactKai Yamasaki

Department of Pediatric Hematology and Oncology, Osaka City General Hospital

ka-yamasaki@med.osakacity-hp.or.jp+81-6-6929-1221

Outcome results

None listed

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