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

• ClinicalTrials.gov Identifier: NCT02161692
• Recruitment Status: Completed
• First Posted: June 12, 2014
• Last Update Posted: June 12, 2014
• Sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
• Information provided by (Responsible Party): Andrea Necchi, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

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.

Condition or disease	Intervention/treatment	Phase
Testicular Neoplasms; Germ Cell Tumors	Drug: Cyclophosphamide; Drug: Etoposide; Drug: Cisplatin; Drug: Bleomycin; Drug: Carboplatin	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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 Start Date: December 1996
• Actual Primary Completion Date: May 2007
• Actual Study Completion Date: April 2009

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

1. Overall survival [ Time Frame: 5 years ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Italy

Istituto Nazionale dei Tumori

Milano, Italy, 20133

Sponsors and Collaborators

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Investigators

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

More Information

Publications:

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Necchi A, Mariani L, Di Nicola M, Lo Vullo S, Nicolai N, Giannatempo P, Raggi D, Farè 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.

• Responsible Party: Andrea Necchi, Faculty, Department of Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
• ClinicalTrials.gov Identifier: NCT02161692
• Other Study ID Numbers: INT48/96
• First Posted: June 12, 2014
• Last Update Posted: June 12, 2014
• Last Verified: June 2014

Additional relevant MeSH terms:

Neoplasms, Germ Cell and Embryonal; Testicular Neoplasms; Neoplasms by Histologic Type; Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Urogenital Neoplasms; Endocrine System Diseases; Testicular Diseases; Gonadal Disorders; Cyclophosphamide; Cisplatin; Carboplatin; Etoposide; Bleomycin; Immunosuppressive Agents; Immunologic Factors; Physiological Effects of Drugs; Antirheumatic Agents; Antineoplastic Agents, Alkylating; Alkylating Agents; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Myeloablative Agonists; Antineoplastic Agents, Phytogenic; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Enzyme Inhibitors; Antibiotics, Antineoplastic