Chemotherapy Plus Reduced Radiotherapy in Intracranial Germinoma

Sponsor

Samsung Medical Center (Other)

Overall Status

Unknown status

CT.gov ID

NCT02782754

Collaborator

(none)

Enrollment

Location

Arm

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Intracranial Germinoma	Drug: Carboplatin Drug: Etoposide Drug: Cyclophosphamide Drug: Bleomycin Radiation: Reduced dose of radiotherapy	Phase 2

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jan 1, 2013

Anticipated Primary Completion Date :

Dec 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intracranial germinoma Four cycles of chemotherapy with carboplatin, etoposide, (+ bleomycin) and cyclophosphamide, etoposide, (+ bleomycin) regimen 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	Drug: Carboplatin Drug: Etoposide Drug: Cyclophosphamide Drug: Bleomycin Radiation: Reduced dose of radiotherapy

Arm

Intervention/Treatment

Experimental: Intracranial germinoma

Four cycles of chemotherapy with carboplatin, etoposide, (+ bleomycin) and cyclophosphamide, etoposide, (+ bleomycin) regimen 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

Drug: Carboplatin

Drug: Etoposide

Drug: Cyclophosphamide

Drug: Bleomycin

Radiation: Reduced dose of radiotherapy

Outcome Measures

Primary Outcome Measures

Rate of late sequelae [Up to 5 years]

Secondary Outcome Measures

Rate of event free survival [Up to 5 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

3 Years to 30 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Samsung Medical Center	Seoul		Korea, Republic of

Sponsors and Collaborators

Samsung Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Samsung Medical Center

ClinicalTrials.gov Identifier:

NCT02782754

Other Study ID Numbers:

2012-10-101

First Posted:

May 25, 2016

Last Update Posted:

May 25, 2016

Last Verified:

May 1, 2016

Additional relevant MeSH terms:

Study Results

No Results Posted as of May 25, 2016