Reduced Dose Radiotherapy Following High Dose Chemotherapy in Intracranial Non-germinomatous Germ Cell Tumor

Intracranial Non-germinomatous Germ Cell Tumor Clinical Trial

Official title:

Reduced-dose Radiotherapy Following High-dose Chemotherapy and Autologous Stem Cell Transplantation in Patients With Central Nervous System Non-germinomatous Germ Cell Tumors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02784054
• Other study ID #: 2013-07-146
• Status: Recruiting
• Phase: Phase 2
• Start date: April 2014
• Est. completion date: March 2023

Study information

• Verified date: March 2020
• Source: Samsung Medical Center
• Contact: Ki Woong Sung, MD, PhD
• Phone: 82-2-3410-3529
• Email: kiwoong.sung[@]samsung.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the outcome of intracranial non-germinomatous germ cell tumor (NGGCT) treated with reduced radiotherapy following high dose chemotherapy and autologous stem cell transplantation (HDCT/auto-SCT).

Description:

Treatment outcome of intracranial NGGCT is around 50% with conventional chemo- and radiotherapy. Also, late sequelae such as endocrinopathy or cognitive problem are unavoidable especially with craniospinal irradiation. In this study, high dose chemotherapy and reduced dose of radiotherapy will be used to improve survival and minimize the late sequelae in the patients with intracranial NGGCT.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: March 2023
• Est. primary completion date: March 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 30 Years

Eligibility

Inclusion Criteria:

• Patients with pathologically proven intracranial non-germinomatous germ cell tumor or

• Patients who have brain mass which are suspected as intracranial germ cell tumor and elevated serum or cerebrospinal fluid alpha-feto protein.

Exclusion Criteria:

• Patients with organ dysfunction (ejection fraction <40%, creatinine > 3 x upper limit of normal (ULN), aspartate aminotransferase/alanine aminotransaminase > 5 x ULN).

• Pregnant or nursing women

Related Conditions & MeSH terms

• Intracranial Non-germinomatous Germ Cell Tumor
• Neoplasms, Germ Cell and Embryonal
• Testicular Neoplasms

Intervention

Drug:
• Carboplatin

• Etoposide

• Cyclophosphamide

• Bleomycin

• Thiotepa

• Melphalan

Radiation:
• Reduced dose 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 event free survival		Up to 3 years
Secondary	Rate of late adverse events		Up to 5 years