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

NCT02784054 | Unknown Phase 2

• 1 other identifier: 2013-07-146
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Intracranial Non-germinomatous Germ Cell Tumor

Outcome Measures

Primary Outcomes (1)

• Rate of event free survival

  Up to 3 years

Secondary Outcomes (1)

• Rate of late adverse events

  Up to 5 years

Study Arms (1)

Intracranial NGGCT

EXPERIMENTAL

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: Carboplatin; Drug: Etoposide; Drug: Cyclophosphamide; Drug: Bleomycin; Drug: Thiotepa; Drug: Melphalan; Radiation: Reduced dose radiotherapy

Interventions

Carboplatin DRUG

Intracranial NGGCT

Etoposide DRUG

Intracranial NGGCT

Cyclophosphamide DRUG

Intracranial NGGCT

Bleomycin DRUG

Intracranial NGGCT

Thiotepa DRUG

Intracranial NGGCT

Melphalan DRUG

Intracranial NGGCT

Reduced dose radiotherapy RADIATION

Intracranial NGGCT

Eligibility Criteria

• Age: 3 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, South Korea

RECRUITING

MeSH Terms

Interventions

Carboplatin; Etoposide; Cyclophosphamide; Bleomycin; Thiotepa; Melphalan

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Glycopeptides; Glycoconjugates; Peptides; Amino Acids, Peptides, and Proteins; Triethylenephosphoramide; Aziridines; Azirines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phenylalanine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids

Central Study Contacts

Ki Woong Sung, MD, PhD

CONTACT

82-2-3410-3529; kiwoong.sung@samsung.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2016
• First Posted: May 26, 2016
• Study Start: April 1, 2014
• Primary Completion: March 1, 2021
• Study Completion: March 1, 2023
• Last Updated: March 19, 2020

Record last verified: 2020-03

Locations

KR (1)