Chemotherapy Plus Reduced Radiotherapy in Intracranial Germinoma

Intracranial Germinoma Clinical Trial

Official title:

Treatment of Intracranial Germinoma With Chemotherapy Prior to Reduced Dose and Volume of Radiotherapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02782754
• Other study ID #: 2012-10-101
• Status: Recruiting
• Phase: Phase 2
• First received: May 23, 2016
• Last updated: May 23, 2016
• Start date: January 2013

Study information

• Verified date: May 2016
• Source: Samsung Medical Center
• Contact: Ki Woong Sung, MD, PhD
• Phone: 82-2-3410-3529
• Email: kiwoong.sung[@]samsung.com
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years to 30 Years

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Germinoma
• Intracranial Germinoma

Intervention

Drug:
• Carboplatin

• Etoposide

• Cyclophosphamide

• Bleomycin

Radiation:
• Reduced dose of radiotherapy

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of late sequelae		Up to 5 years	Yes
Secondary	Rate of event free survival		Up to 5 years	Yes