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Trial record 1 of 6 for:    "Germinoma" | "Antibiotics, Antitubercular"
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Chemotherapy Plus Reduced Radiotherapy in Intracranial Germinoma

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ClinicalTrials.gov Identifier: NCT02782754
Recruitment Status : Unknown
Verified May 2016 by Samsung Medical Center.
Recruitment status was:  Recruiting
First Posted : May 25, 2016
Last Update Posted : May 25, 2016
Sponsor:
Information provided by (Responsible Party):
Samsung Medical Center

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
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 : January 2013
Estimated Primary Completion Date : December 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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
Drug: Carboplatin
Drug: Etoposide
Drug: Cyclophosphamide
Drug: Bleomycin
Radiation: Reduced dose of radiotherapy



Primary Outcome Measures :
  1. Rate of late sequelae [ Time Frame: Up to 5 years ]

Secondary Outcome Measures :
  1. Rate of event free survival [ Time Frame: Up to 5 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02782754


Contacts
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Contact: Ki Woong Sung, MD, PhD 82-2-3410-3529 kiwoong.sung@samsung.com

Locations
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Korea, Republic of
Samsung Medical Center Recruiting
Seoul, Korea, Republic of
Contact: Ki Woong Sung    82-2-3410-3529    kwsped@skku.edu   
Principal Investigator: Ki Woong Sung         
Sponsors and Collaborators
Samsung Medical Center

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Responsible Party: Samsung Medical Center
ClinicalTrials.gov Identifier: NCT02782754     History of Changes
Other Study ID Numbers: 2012-10-101
First Posted: May 25, 2016    Key Record Dates
Last Update Posted: May 25, 2016
Last Verified: May 2016

Additional relevant MeSH terms:
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Germinoma
Antibiotics, Antineoplastic
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Cyclophosphamide
Carboplatin
Etoposide
Etoposide phosphate
Bleomycin
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors