Chemotherapy Plus Reduced Radiotherapy in Intracranial Germinoma

Phase 2

• Conditions: Intracranial Germinoma
• Interventions: Drug: Carboplatin; Drug: Etoposide; Drug: Cyclophosphamide; Drug: Bleomycin; Radiation: Reduced dose of radiotherapy

• Registration Number: NCT02782754
• Lead Sponsor: Samsung Medical Center

Brief Summary

The purpose of this study is to evaluate the outcome of intracranial germinoma treated with chemotherapy plus reduced radiotherapy.

Detailed Description

Treatment outcome of intracranial germinoma is excellent with radiotherapy/chemotherapy. However, late sequelae are unavoidable especially with craniospinal irradiation, and various efforts have been done to reduce the dose and extent of radiotherapy. In this study, chemotherapy and further reduced dose of radiotherapy will be used to minimize the late sequelae in the patients with intracranial germinoma.

Study Timeline

• Study Start: 2013-01
• Status Verified: 2016-05
• Study First Submitted: 2016-05-23
• Study First Submitted QC: 2016-05-23
• Last Update Submitted: 2016-05-23
• Study First Posted: 2016-05-25
• Last Update Posted: 2016-05-25
• Primary Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Patients with pathologically proven intracranial germinoma

Exclusion Criteria

• Elevated serum/cerebrospinal fluid alpha-feto protein
• Patients with organ dysfunction as follows (creatinine elevation, ejection fraction, liver function test > CTCAE grade 2)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intracranial germinoma	Reduced dose of radiotherapy	1. Four cycles of chemotherapy with carboplatin, etoposide, (+ bleomycin) and cyclophosphamide, etoposide, (+ bleomycin) regimen 2. Reduced dose of radiotherapy * Without seeding: 18 Gy to ventricle + 12.6 Gy to primary site * With seeding: craniospinal irradiation 18 Gy + 12.6 Gy to primary site
Intracranial germinoma	Carboplatin	1. Four cycles of chemotherapy with carboplatin, etoposide, (+ bleomycin) and cyclophosphamide, etoposide, (+ bleomycin) regimen 2. Reduced dose of radiotherapy * Without seeding: 18 Gy to ventricle + 12.6 Gy to primary site * With seeding: craniospinal irradiation 18 Gy + 12.6 Gy to primary site
Intracranial germinoma	Cyclophosphamide	1. Four cycles of chemotherapy with carboplatin, etoposide, (+ bleomycin) and cyclophosphamide, etoposide, (+ bleomycin) regimen 2. Reduced dose of radiotherapy * Without seeding: 18 Gy to ventricle + 12.6 Gy to primary site * With seeding: craniospinal irradiation 18 Gy + 12.6 Gy to primary site
Intracranial germinoma	Etoposide	1. Four cycles of chemotherapy with carboplatin, etoposide, (+ bleomycin) and cyclophosphamide, etoposide, (+ bleomycin) regimen 2. Reduced dose of radiotherapy * Without seeding: 18 Gy to ventricle + 12.6 Gy to primary site * With seeding: craniospinal irradiation 18 Gy + 12.6 Gy to primary site
Intracranial germinoma	Bleomycin	1. Four cycles of chemotherapy with carboplatin, etoposide, (+ bleomycin) and cyclophosphamide, etoposide, (+ bleomycin) regimen 2. Reduced dose of radiotherapy * Without seeding: 18 Gy to ventricle + 12.6 Gy to primary site * With seeding: craniospinal irradiation 18 Gy + 12.6 Gy to primary site

Primary Outcome Measures

Name	Time	Method
Rate of late sequelae	Up to 5 years

Secondary Outcome Measures

Name	Time	Method
Rate of event free survival	Up to 5 years

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of