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

Institute of Cancer Research, United Kingdom

Status and phase: Completed; Phase 3

Conditions: Stage I Testicular Non-Seminomatous Germ Cell Tumor

Treatments: Drug: BEP(500)

Study type: Interventional

Funder types: Other

Identifiers

NCT01726374

ICR-CTSU/2008/10019

ISRCTN37875250 (Registry Identifier)

09/H1102/86 (Other Identifier)

CRUK/09/011 (Other Grant/Funding Number)

2008-006295-29 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 246 patients

Sex: Male

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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246 participants in 1 patient group

One cycle adjuvant BEP(500)

Experimental group

Description:

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

Treatment:

Drug: BEP(500)