Trial of 1 Cycle of Adjuvant BEP Chemotherapy in High Risk, Stage 1 Non-seminomatous Germ Cell Testis Tumours (111)
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| ClinicalTrials.gov Identifier: NCT01726374 |
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Recruitment Status :
Active, not recruiting
First Posted : November 14, 2012
Last Update Posted : May 4, 2020
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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 |
| 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 |
| Arm | Intervention/treatment |
|---|---|
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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
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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 |
- Recurrence [ Time Frame: 2 years ]To demonstrate that one cycle of adjuvant BEP(500) reduces 2 year recurrence rate to less than 5%
- Immediate and delayed toxicity including long-term permanent infertility (>2 years) [ Time Frame: 0 - > 2 years ]
- Relapse free survival [ Time Frame: Patients followed up for 5 years ]
- Overall survival [ Time Frame: Patients followed up for 5 years ]
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| Ages Eligible for Study: | 16 Years and older (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
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
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
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| Principal Investigator: | Professor Michael Cullen | University Hospitals Birmingham NHS Foundation Trust |
| 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 |
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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 |