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Completed

NCT Number: NCT02161692

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

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.

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Key information

Conditions

Testicular Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Germ Cell Tumors Gonadal Disorders Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Testicular Diseases Urogenital Diseases Urogenital Neoplasms

Age range

18 year–75 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Istituto Nazionale dei Tumori

Milan, Milano, 20133, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cyclophosphamide

Drug

etoposide

Drug

Cisplatin

Drug

Bleomycin

Drug

carboplatin

Drug

High dose carboplatin

Primary outcomes

  1. Evidence of disease progression confirmed by computed tomography (CT) scan and/or serum tumor markers.

    Time frame: 5 years

Secondary outcomes

  1. Overall survival

    Time frame: 5 years

Sponsors and collaborators

Lead sponsor

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Other

Registry information

Official study 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

Important dates

Study start
1996
Primary completion
2007
Study completion
2009
First posted
Jun 12, 2014
Registry last updated
Jun 12, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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