One cycle of adjuvant bleomycin, etoposide, cisplatin (BEP) chemotherapy in high risk, stage one non-seminomatous germ cell tumours of the testis (NSGCTT)

Phase 3

Completed

• Conditions: ewly diagnosed non-seminomatous germ cell tumours of the testis (NSGCTT)/mixed germ cell tumours (MGCT) with vascular invasion and stage one disease; Cancer; Malignant neoplasm of testis

• Registration Number: ISRCTN37875250
• Lead Sponsor: Institute of Cancer Research (UK)

Brief Summary

2020 results in https://www.ncbi.nlm.nih.gov/pubmed/31901440 (added 24/02/2020)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-05-14
• Study Completion: 2019-08-31
• Last Update Posted: 11 May 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 246

Inclusion Criteria

1. Histologically proven non-seminomatous germ cell tumour (GCT) or mixed GCT (MGCT) of the testis
2. Histological proven vascular invasion of the primary tumour into the testicular veins or lymphatics
3. Clinical stage I patients (normal alpha-fetoprotein [AFP] and human chorionic gonadotropin [HCG], or optimum marker decline approaching normal levels after orchidectomy, no evidence of metastases on computed tomography [CT] of the chest, abdomen and pelvis)
4. Men aged greater than or equal to 16 years
5. Creatinine clearance greater than 50 ml/min
6. No previous chemotherapy
7. White blood cells (WBC) greater than 1.5 x 10^9/l and platelets greater than 100 x 10^9/l
8. Fit to receive chemotherapy
9. Able to start BEP chemotherapy as part of 111 study within 6 weeks* of orchidectomy
10. Written informed consent

*It is strongly recommended based on previous studies that adjuvant chemotherapy should start within 6 weeks of orchidectomy. However, if there are unavoidable delays this timescale can be extended to 8 weeks.

Exclusion Criteria

1. All patients with seminoma
2. All patients with non-seminoma greater than clinical stage 1
3. All patients with no vascular invasion
4. Previous chemotherapy
5. Patients with second malignancy except contralateral testicular intraepithelial neoplasia (TIN) and contralateral germ cell tumour treated by orchidectomy and subsequent surveillance of more then 3 years
6. Co-morbidity precluding the safe administration of BEP chemotherapy
7. Patients with renal function impairment (creatinine clearance less than or equal to 50 ml/min)
8. Patients with liver function impairment (bilirubin greater than 1.25 x upper limit of normal [ULN] and/or aspartate aminotransferase [AST] greater than 2 x ULN)
9. Patients with pre-existing neuropathy
10. Patients with pulmonary fibrosis
11. Patients with serious illness or medical conditions incompatible with the protocol

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Recurrence at 2 years (trial aims to show a 2 year recurrence rate of less that 5%).

Secondary Outcome Measures

Name	Time	Method
<br> 1. Immediate and delayed toxicity (CTC) including long-term permanent infertility (greater than 2 years)<br> 2. Contralateral second primary testicular germ cell malignancy<br> 3. Relapse free survival<br> 4. Overall survival<br><br> Measurement timings are between 4 - 5 years approximately with a yearly review of trial data by the Independent Data Monitoring Committee (IDMC).<br>