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

Testicular Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02161692
• Other study ID #: INT48/96
• Status: Completed
• Phase: Phase 2
• First received: June 10, 2014
• Last updated: June 11, 2014
• Start date: December 1996
• Est. completion date: April 2009

Study information

• Verified date: June 2014
• Source: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: The Italian Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: April 2009
• Est. primary completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Germ Cell Tumors
• Neoplasms, Germ Cell and Embryonal
• Testicular Neoplasms

Intervention

Drug:
• Cyclophosphamide

• Etoposide

• Cisplatin

• Bleomycin

• Carboplatin
High dose carboplatin

Locations

Country	Name	City	State
Italy	Istituto Nazionale dei Tumori	Milano

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Country where clinical trial is conducted

Italy, 

References & Publications (1)

Lorch A, Bascoul-Mollevi C, Kramar A, Einhorn L, Necchi A, Massard C, De Giorgi U, Fléchon A, Margolin K, Lotz JP, Germà-Lluch JR, Powles T, Kollmannsberger C, Beyer J. Conventional-dose versus high-dose chemotherapy as first salvage treatment in male patients with metastatic germ cell tumors: evidence from a large international database. J Clin Oncol. 2011 Jun 1;29(16):2178-84. doi: 10.1200/JCO.2010.32.6678. Epub 2011 Mar 28. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evidence of disease progression confirmed by computed tomography (CT) scan and/or serum tumor markers.		5 years	No
Secondary	Overall survival		5 years	No

External Links

•   Website of the Urology Unit, Istituto Nazionale dei Tumori, Milano Italy