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

NCT ID: NCT02784054

Last Updated: 2020-03-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2023-03-31

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Intracranial Non-germinomatous Germ Cell Tumor

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Carboplatin

Intervention Type DRUG

Etoposide

Intervention Type DRUG

Cyclophosphamide

Intervention Type DRUG

Bleomycin

Intervention Type DRUG

Thiotepa

Intervention Type DRUG

Melphalan

Intervention Type DRUG

Reduced dose radiotherapy

Intervention Type RADIATION

Interventions

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Carboplatin

Intervention Type DRUG

Etoposide

Intervention Type DRUG

Cyclophosphamide

Intervention Type DRUG

Bleomycin

Intervention Type DRUG

Thiotepa

Intervention Type DRUG

Melphalan

Intervention Type DRUG

Reduced dose radiotherapy

Intervention Type RADIATION

Eligibility Criteria

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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
Minimum Eligible Age

3 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Samsung Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Samsung Medical Center

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Ki Woong Sung, MD, PhD

Role: CONTACT

82-2-3410-3529

Facility Contacts

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Ki Woong Sung

Role: primary

82-2-3410-3529

Other Identifiers

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2013-07-146

Identifier Type: -

Identifier Source: org_study_id

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