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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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.

Condition or disease Intervention/treatment Phase
Testicular Neoplasms Germ Cell Tumors Drug: Cyclophosphamide Drug: Etoposide Drug: Cisplatin Drug: Bleomycin Drug: Carboplatin Phase 2

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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Phase 2 Study of Conventional Dose Chemotherapy Versus High Dose Sequential Chemotherapy as First-line Therapy for Metastatic Poor Prognosis Germ Cell Tumors
Study Start Date : December 1996
Actual Primary Completion Date : May 2007
Actual Study Completion Date : April 2009

Arm Intervention/treatment
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

Drug: Cyclophosphamide
Drug: Etoposide
Drug: Cisplatin
Drug: Carboplatin
High dose carboplatin

Active Comparator: Conventional dose chemotherapy
Cisplatin, Etoposide, and Bleomycin (PEB) x 4 cycles
Drug: Etoposide
Drug: Cisplatin
Drug: Bleomycin



Primary Outcome Measures :
  1. Evidence of disease progression confirmed by computed tomography (CT) scan and/or serum tumor markers. [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. Overall survival [ Time Frame: 5 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT02161692


Locations
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Italy
Istituto Nazionale dei Tumori
Milano, Italy, 20133
Sponsors and Collaborators
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Investigators
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Principal Investigator: Andrea Necchi, MD Istituto Nazionale dei Tumori, Milano Italy
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Andrea Necchi, Faculty, Department of Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
ClinicalTrials.gov Identifier: NCT02161692    
Other Study ID Numbers: INT48/96
First Posted: June 12, 2014    Key Record Dates
Last Update Posted: June 12, 2014
Last Verified: June 2014
Additional relevant MeSH terms:
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Neoplasms, Germ Cell and Embryonal
Testicular Neoplasms
Neoplasms by Histologic Type
Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Genital Neoplasms, Male
Urogenital Neoplasms
Endocrine System Diseases
Testicular Diseases
Gonadal Disorders
Cyclophosphamide
Carboplatin
Etoposide
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
Antibiotics, Antineoplastic