ACNS0332: Efficacy of Carboplatin Administered Concomitantly With Radiation and Isotretinoin as a Pro-Apoptotic Agent in Other Than Average Risk Medulloblastoma/PNET Patients - A Groupwide Phase III Study

Phase 3

Recruiting

• Conditions: medulloblastoma; pnet; malignant brain tumor; 10029211

• Registration Number: NL-OMON41634
• Lead Sponsor: Stichting Kinderoncologie Nederland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 21

Inclusion Criteria

Age greater or equal to 3 y and less than 22 y at time of diagnosis
Newly diagnosed previously untreated medulloblastoma (M0 with >1.5 cm2 residual, or M1-3); (amendment 2: inclusion sPNET discontinued)
Written informed consent (parents and patient)

Exclusion Criteria

Age less than 3 y
Extraneural metastases
Karnofski/Lansky < 50% and life expectancy <= 8 weeks
Inadequate organ function prior to start of therapy (renal, liver, bonemarrow)
Previous chemotherapy or radiation therapy
Other experimental therapy

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To determine whether carboplatin radiosensitization increases long term<br /><br>event-free survival for high risk<br /><br>medulloblastoma/PNET patients.<br /><br><br /><br>To determine whether Isotretinoin increases long term event-free survival for<br /><br>high risk<br /><br>medulloblastoma/PNET patients.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>To compare residual disease response to radiation alone versus radiation plus<br /><br>carboplatin.<br /><br><br /><br>To identify molecular prognostic indicators suitable for patient stratification<br /><br>in future trials.</p><br>