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

Tracking Information

• First Submitted Date: June 10, 2014
• First Posted Date: June 12, 2014
• Last Update Posted Date: June 12, 2014
• Study Start Date: December 1996
• Actual Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: June 11, 2014): Evidence of disease progression confirmed by computed tomography (CT) scan and/or serum tumor markers. [ Time Frame: 5 years ]
• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted
• Current Secondary Outcome Measures (submitted: June 11, 2014): Overall survival [ Time Frame: 5 years ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Testicular Neoplasms
• Germ Cell Tumors

Intervention

• Drug: Cyclophosphamide
• Drug: Etoposide
• Drug: Cisplatin
• Drug: Bleomycin
• Drug: Carboplatin
  High dose carboplatin

Study Arms

• 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

  Interventions:

  • Drug: Cyclophosphamide
  • Drug: Etoposide
  • Drug: Cisplatin
  • Drug: Carboplatin
• Active Comparator: Conventional dose chemotherapy
  Cisplatin, Etoposide, and Bleomycin (PEB) x 4 cycles
  Interventions:

  • Drug: Etoposide
  • Drug: Cisplatin
  • Drug: Bleomycin

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.
• 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.

Recruitment Information

• Recruitment Status: Completed
• Enrollment: Not Provided
• Original Enrollment: Not Provided
• Actual Study Completion Date: April 2009
• Actual Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: Male

• Ages: 18 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Italy

Administrative Information

• NCT Number: NCT02161692
• Other Study ID Numbers: INT48/96
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Andrea Necchi, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
• Study Sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
• Collaborators: Not Provided

Investigators

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

• PRS Account: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
• Verification Date: June 2014