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Conventional Dose Versus High Dose Sequential Chemotherapy for Poor Prognosis Germ Cell Tumors

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ClinicalTrials.gov Identifier: NCT02161692
Recruitment Status : Completed
First Posted : June 12, 2014
Last Update Posted : June 12, 2014
Sponsor:
Information provided by (Responsible Party):
Andrea Necchi, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Tracking Information
First Submitted Date  ICMJE June 10, 2014
First Posted Date  ICMJE June 12, 2014
Last Update Posted Date June 12, 2014
Study Start Date  ICMJE December 1996
Actual Primary Completion Date May 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 11, 2014)
Evidence of disease progression confirmed by computed tomography (CT) scan and/or serum tumor markers. [ Time Frame: 5 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 11, 2014)
Overall survival [ Time Frame: 5 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Conventional Dose Versus High Dose Sequential Chemotherapy for Poor Prognosis Germ Cell Tumors
Official Title  ICMJE Randomized Phase 2 Study of Conventional Dose Chemotherapy Versus High Dose Sequential Chemotherapy as First-line Therapy for Metastatic Poor Prognosis Germ Cell Tumors
Brief Summary The purpose of this study is to determine whether the use of a sequential high dose chemotherapy is more effective than conventional dose (i.e. 4 cycles of cisplatin, etoposide, and bleomycin [PEB]) in patients with metastatic poor prognosis germ cell tumors.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Testicular Neoplasms
  • Germ Cell Tumors
Intervention  ICMJE
  • Drug: Cyclophosphamide
  • Drug: Etoposide
  • Drug: Cisplatin
  • Drug: Bleomycin
  • Drug: Carboplatin
    High dose carboplatin
Study Arms  ICMJE
  • Experimental: High dose chemotherapy

    Characterized by the following sequence:

    High dose cyclophosphamide (7 grams/squared meter) x 1 cycle 2 cycles of high-dose etoposide and cisplatin

    1 cycle of high dose carboplatin (Area Under the Curve 27) with stem cell rescue

    Interventions:
    • Drug: Cyclophosphamide
    • Drug: Etoposide
    • Drug: Cisplatin
    • Drug: Carboplatin
  • Active Comparator: Conventional dose chemotherapy
    Cisplatin, Etoposide, and Bleomycin (PEB) x 4 cycles
    Interventions:
    • Drug: Etoposide
    • Drug: Cisplatin
    • Drug: Bleomycin
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE Not Provided
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE April 2009
Actual Primary Completion Date May 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Clinical or Histological diagnosis of germ cell tumors
  • Metastatic disease
  • Poor prognostic category according to the International Germ Cell Collaborative Group (IGCCCG) classification
  • No prior chemotherapy for metastatic disease

Exclusion Criteria:

  • Unwillingness to accomplish the study procedures
  • Any existing co-morbidity that could limit the administration of high dose chemotherapy
  • Any psychiatric disorder that could impact on the study compliance
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02161692
Other Study ID Numbers  ICMJE INT48/96
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Andrea Necchi, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Study Sponsor  ICMJE Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Andrea Necchi, MD Istituto Nazionale dei Tumori, Milano Italy
PRS Account Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Verification Date June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP