Trial of 1 Cycle of Adjuvant BEP Chemotherapy in High Risk, Stage 1 Non-seminomatous Germ Cell Te… (NCT01726374) | Clinical Trial Compass
CompletedPhase 3
Trial of 1 Cycle of Adjuvant BEP Chemotherapy in High Risk, Stage 1 Non-seminomatous Germ Cell Testis Tumours
United Kingdom246 participantsStarted 2010-02
Plain-language 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.
Who can participate
Age range
16 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Recurrence
Timeframe: 2 years
Trial details
NCT IDNCT01726374
SponsorInstitute of Cancer Research, United Kingdom