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

Primary Purpose

Testicular Neoplasms, Germ Cell Tumors

Status
Completed
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
Cyclophosphamide
Etoposide
Cisplatin
Bleomycin
Carboplatin
Sponsored by
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Testicular Neoplasms

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Istituto Nazionale dei Tumori

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

High dose chemotherapy

Conventional dose chemotherapy

Arm Description

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

Cisplatin, Etoposide, and Bleomycin (PEB) x 4 cycles

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Overall survival

Full Information

First Posted
June 10, 2014
Last Updated
June 11, 2014
Sponsor
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
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1. Study Identification

Unique Protocol Identification Number
NCT02161692
Brief Title
Conventional Dose Versus High Dose Sequential Chemotherapy for Poor Prognosis Germ Cell Tumors
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 Type
Interventional

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
December 1996 (undefined)
Primary Completion Date
May 2007 (Actual)
Study Completion Date
April 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Testicular Neoplasms, Germ Cell Tumors

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized

8. Arms, Groups, and Interventions

Arm Title
High dose chemotherapy
Arm Type
Experimental
Arm Description
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
Arm Title
Conventional dose chemotherapy
Arm Type
Active Comparator
Arm Description
Cisplatin, Etoposide, and Bleomycin (PEB) x 4 cycles
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Intervention Type
Drug
Intervention Name(s)
Etoposide
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Type
Drug
Intervention Name(s)
Bleomycin
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Intervention Description
High dose carboplatin
Primary Outcome Measure Information:
Title
Evidence of disease progression confirmed by computed tomography (CT) scan and/or serum tumor markers.
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Overall survival
Time Frame
5 years

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrea Necchi, MD
Organizational Affiliation
Istituto Nazionale dei Tumori, Milano Italy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istituto Nazionale dei Tumori
City
Milano
ZIP/Postal Code
20133
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
21444870
Citation
Lorch A, Bascoul-Mollevi C, Kramar A, Einhorn L, Necchi A, Massard C, De Giorgi U, Flechon A, Margolin K, Lotz JP, Germa-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.
Results Reference
background
PubMed Identifier
25344361
Citation
Necchi A, Mariani L, Di Nicola M, Lo Vullo S, Nicolai N, Giannatempo P, Raggi D, Fare E, Magni M, Piva L, Matteucci P, Catanzaro M, Biasoni D, Torelli T, Stagni S, Bengala C, Barone C, Schiavetto I, Siena S, Carlo-Stella C, Pizzocaro G, Salvioni R, Gianni AM. High-dose sequential chemotherapy (HDS) versus PEB chemotherapy as first-line treatment of patients with poor prognosis germ-cell tumors: mature results of an Italian randomized phase II study. Ann Oncol. 2015 Jan;26(1):167-172. doi: 10.1093/annonc/mdu485. Epub 2014 Oct 24.
Results Reference
derived

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

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