Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Trial of 1 Cycle of Adjuvant BEP Chemotherapy in High Risk, Stage 1 Non-seminomatous Germ Cell Testis Tumours (111)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01726374
Recruitment Status : Active, not recruiting
First Posted : November 14, 2012
Last Update Posted : May 4, 2020
Sponsor:
Collaborators:
University Hospital Birmingham NHS Foundation Trust
Cancer Research UK
Information provided by (Responsible Party):
Institute of Cancer Research, United Kingdom

Brief Summary:

High-risk stage 1 NSGCTTs are curable with careful surveillance followed by 3 cycles of BEP (bleomycin, etoposide, cisplatin with 500mg/m2 of etoposide per cycle) chemotherapy for the 40-50% of cases experiencing recurrence. Alternatively, adjuvant chemotherapy with 2 cycles of BEP(at a lower dose than that used for advanced disease - etoposide 360mg/m2) for these patients achieves the same outcome and avoids intensive surveillance, but delivers 33% more chemotherapy cycles on a population basis.

If a single cycle of BEP at the dose used in advanced disease had a similar high rate of relapse-free survival (cure) to that seen with two lower dose cycles, this would reduce the overall burden of chemotherapy and healthcare resource usage and would be likely to lead to a change in practice globally.


Condition or disease Intervention/treatment Phase
Stage I Testicular Non-Seminomatous Germ Cell Tumor Drug: BEP(500) Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 246 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single Group Trial Evaluating One Cycle of Adjuvant BEP Chemotherapy in High Risk, Stage 1 Non-seminomatous Germ Cell Tumours of the Testis (NSGCTT)
Actual Study Start Date : February 2010
Actual Primary Completion Date : August 2016
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: One cycle adjuvant BEP(500)
Etoposide 165 mg/m2 IV infusion - days 1, 2, 3 Cisplatin 50 mg/m2 IV infusion - days 1, 2 Bleomycin 30,000 IU IV infusion - days 1 (or 2), 8, 15
Drug: BEP(500)

One cycle of BEP(500):

Etoposide 165 mg/m2 IV infusion - days 1, 2, 3 Cisplatin 50 mg/m2 IV infusion - days 1, 2 Bleomycin 30,000 IU IV infusion - days 1 (or 2), 8, 15





Primary Outcome Measures :
  1. Recurrence [ Time Frame: 2 years ]
    To demonstrate that one cycle of adjuvant BEP(500) reduces 2 year recurrence rate to less than 5%


Secondary Outcome Measures :
  1. Immediate and delayed toxicity including long-term permanent infertility (>2 years) [ Time Frame: 0 - > 2 years ]
  2. Relapse free survival [ Time Frame: Patients followed up for 5 years ]
  3. Overall survival [ Time Frame: Patients followed up for 5 years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically proven non-seminomatous germ cell tumour of combined GCT (NSGCT + seminoma)of the testis
  • Histologically proven vascular invasion of the primary tumour into the testicular veins or lymphatics
  • Clinical stage 1 patients (normal AFP and HCG, or optimum marker decline approaching normal levels after orchidectomy AND no evidence of metastases on CT of chest, abdomen and pelvis)
  • Men aged 16 years or over
  • Creatinine clearance > 50 ml/min
  • No previous chemotherapy
  • WBC > 1.5 x 10^9/l and platelets 100 x 10^9/l
  • Fit to receive chemotherapy
  • Able to start BEP(500) chemotherapy as part of 111 study within 6* weeks of orchidectomy
  • Written informed consent *If there are unavoidable delays this timescale can be extended to 8 weeks

Exclusion Criteria:

  • All patients with pure seminoma
  • All patients with non-seminoma or combined NSGCT + seminoma > stage 1
  • All patients with no vascular invasion
  • Previous chemotherapy
  • Patients with second malignancy except contralateral TIN and contralateral germ cell tumour treated by orchidectomy and subsequent surveillance of more than 3 years
  • Co-morbidity precluding the safe administration of BEP(500) chemotherapy
  • Patients with renal function impairment (bilirubin >1.25 x ULN and/or AST >2 x ULN)
  • Patients with pre-existing neuropathy
  • Patients with pulmonary fibrosis
  • Patients with serious illness or medical conditions incompatible with the protocol

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01726374


Locations
Show Show 35 study locations
Sponsors and Collaborators
Institute of Cancer Research, United Kingdom
University Hospital Birmingham NHS Foundation Trust
Cancer Research UK
Investigators
Layout table for investigator information
Principal Investigator: Professor Michael Cullen University Hospitals Birmingham NHS Foundation Trust
Publications of Results:
Layout table for additonal information
Responsible Party: Institute of Cancer Research, United Kingdom
ClinicalTrials.gov Identifier: NCT01726374    
Other Study ID Numbers: ICR-CTSU/2008/10019
ISRCTN37875250 ( Registry Identifier: ISRCTN )
2008-006295-29 ( EudraCT Number )
09/H1102/86 ( Other Identifier: Main REC )
CRUK/09/011 ( Other Grant/Funding Number: CRUK )
First Posted: November 14, 2012    Key Record Dates
Last Update Posted: May 4, 2020
Last Verified: April 2020
Additional relevant MeSH terms:
Layout table for 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