Chemotherapy Plus Reduced Radiotherapy in Intracranial Germinoma

NCT ID: NCT02782754

Last Updated: 2016-05-25

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

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Intracranial Germinoma

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 germinoma

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

Group Type EXPERIMENTAL

Carboplatin

Intervention Type DRUG

Etoposide

Intervention Type DRUG

Cyclophosphamide

Intervention Type DRUG

Bleomycin

Intervention Type DRUG

Reduced dose of 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

Reduced dose of radiotherapy

Intervention Type RADIATION

Eligibility Criteria

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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)
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

References

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Lee JW, Lim DH, Sung KW, Cho HW, Ju HY, Yoo KH, Koo HH, Kim JH, Suh YL, Shin HJ. Induction Chemotherapy Reduces Radiation Therapy Dose and Volume in the Treatment of Intracranial Germinoma: Results of the SMC-G13 Trial. Int J Radiat Oncol Biol Phys. 2020 Nov 1;108(3):649-656. doi: 10.1016/j.ijrobp.2020.05.051. Epub 2020 Jun 2.

Reference Type DERIVED
PMID: 32502506 (View on PubMed)

Other Identifiers

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2012-10-101

Identifier Type: -

Identifier Source: org_study_id

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