Phase II study of multimodality treatment for ATRT

Phase 2

Recruiting

• Conditions: Atypical teratoid rhabdoid tumor; D016543

• Registration Number: JPRN-jRCTs051200071
• Lead Sponsor: Junichi Hara

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-10-22
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 50

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
3-year progression free survival (3yr-PFS)

Secondary Outcome Measures

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