Conventional Dose Versus High Dose Sequential Chemotherapy for Poor Prognosis Germ Cell Tumors
NCT ID: NCT02161692
Last Updated: 2014-06-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
INTERVENTIONAL
1996-12-31
2009-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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
Cyclophosphamide
Etoposide
Cisplatin
Carboplatin
High dose carboplatin
Conventional dose chemotherapy
Cisplatin, Etoposide, and Bleomycin (PEB) x 4 cycles
Etoposide
Cisplatin
Bleomycin
Interventions
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Cyclophosphamide
Etoposide
Cisplatin
Bleomycin
Carboplatin
High dose carboplatin
Eligibility Criteria
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Inclusion Criteria
* Metastatic disease
* Poor prognostic category according to the International Germ Cell Collaborative Group (IGCCCG) classification
* No prior chemotherapy for metastatic disease
Exclusion Criteria
* Any existing co-morbidity that could limit the administration of high dose chemotherapy
* Any psychiatric disorder that could impact on the study compliance
18 Years
75 Years
MALE
No
Sponsors
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Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
OTHER
Responsible Party
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Andrea Necchi
Faculty, Department of Medical Oncology
Principal Investigators
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Andrea Necchi, MD
Role: PRINCIPAL_INVESTIGATOR
Istituto Nazionale dei Tumori, Milano Italy
Locations
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Istituto Nazionale dei Tumori
Milan, Milano, Italy
Countries
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References
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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.
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.
Other Identifiers
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INT48/96
Identifier Type: -
Identifier Source: org_study_id
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