Chemotherapy Plus Reduced Radiotherapy in Intracranial Germinoma

Samsung Medical Center

Status and phase: Unknown; Phase 2

Conditions: Intracranial Germinoma

Treatments: Drug: Cyclophosphamide; Drug: Etoposide; Radiation: Reduced dose of radiotherapy; Drug: Bleomycin; Drug: Carboplatin

Study type: Interventional

Funder types: Other

Identifiers

NCT02782754

2012-10-101

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 3 to 30 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Intracranial germinoma

Experimental group

Description:

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

Treatment:

Drug: Cyclophosphamide

Drug: Etoposide

Drug: Bleomycin

Drug: Carboplatin

Radiation: Reduced dose of radiotherapy