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

June 11, 2014 updated by: Andrea Necchi, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Randomized Phase 2 Study of Conventional Dose Chemotherapy Versus High Dose Sequential Chemotherapy as First-line Therapy for Metastatic 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Milano, Italy, 20133
        • Istituto Nazionale dei Tumori

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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: Cisplatin
Drug: Etoposide
Drug: Carboplatin
High dose carboplatin
Active Comparator: Conventional dose chemotherapy
Cisplatin, Etoposide, and Bleomycin (PEB) x 4 cycles
Drug: Bleomycin
Drug: Cisplatin
Drug: Etoposide

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Investigators

  • Principal Investigator: Andrea Necchi, MD, Istituto Nazionale dei Tumori, Milano Italy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 1996

Primary Completion (Actual)

May 1, 2007

Study Completion (Actual)

April 1, 2009

Study Registration Dates

First Submitted

June 10, 2014

First Submitted That Met QC Criteria

June 11, 2014

First Posted (Estimate)

June 12, 2014

Study Record Updates

Last Update Posted (Estimate)

June 12, 2014

Last Update Submitted That Met QC Criteria

June 11, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INT48/96

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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