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

March 18, 2020 updated by: Samsung Medical Center

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

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

25

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 30 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intracranial NGGCT
  1. Six cycles of chemotherapy with carboplatin, etoposide, bleomycin (CEB) and cyclophosphamide, etoposide, bleomycin (CyEB) regimen.
  2. Peripheral blood stem cell collection during the first cycle of chemotherapy.
  3. Surgery, if there is residual tumor after chemotherapy.

  4. Tandem high dose chemotherapy (HDCT) and autologous stem cell transplantation (auto-SCT)

    • 1st HDCT: Carboplatin, thiotepa, etoposide
    • 2nd HDCT: Cyclophosphamide, melphalan
  5. Reduced dose of radiotherapy
Drug: Cyclophosphamide
Drug: Bleomycin
Drug: Carboplatin
Drug: Melphalan
Drug: Etoposide
Drug: Thiotepa
Radiation: Reduced dose radiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Rate of event free survival
Time Frame: Up to 3 years
Up to 3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Rate of late adverse events
Time Frame: Up to 5 years
Up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsung Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Anticipated)

March 1, 2021

Study Completion (Anticipated)

March 1, 2023

Study Registration Dates

First Submitted

May 24, 2016

First Submitted That Met QC Criteria

May 24, 2016

First Posted (Estimate)

May 26, 2016

Study Record Updates

Last Update Posted (Actual)

March 19, 2020

Last Update Submitted That Met QC Criteria

March 18, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013-07-146

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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