Stage I Testicular Non-Seminomatous Germ Cell Tumor
Conditions
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.
Interventions
DRUGBEP(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
Sponsors
University Hospital Birmingham NHS Foundation Trust
Cancer Research UK
Institute of Cancer Research, United Kingdom
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
16 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence | 2 years | To demonstrate that one cycle of adjuvant BEP(500) reduces 2 year recurrence rate to less than 5% |
Secondary
| Measure | Time frame |
|---|---|
| Immediate and delayed toxicity including long-term permanent infertility (>2 years) | 0 - > 2 years |
| Relapse free survival | Patients followed up for 5 years |
| Overall survival | Patients followed up for 5 years |
Countries
United Kingdom
Outcome results
None listed