A randomised phase III toxicity study of day 2, 8, 15 short (30 minute) versus day 1, 2, 3 long (72 hours) infusion bleomycin for patients with International Germ Cell Cancer Collaborative Group (IGCCCG) good prognosis germ cell tumours, TE3
- Conditions
- CancerIGCCCG Good Prognosis Germ Cell TumoursGerm cell tumours
- Registration Number
- ISRCTN08648791
- Lead Sponsor
- Barts and The London NHS Trust (UK)
- Brief Summary
2017 results in: https://www.ncbi.nlm.nih.gov/pubmed/28327896 [added 07/03/2019]
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Male
- Target Recruitment
- 212
1. Patients aged 16 - 50 inclusive
2. Patients with proven good risk metastatic germ cell cancer of the testis
3. Patients eligible for treatment with bleomycin, etoposide and cisplatin
4. Patients who are able to understand their participation in the study and give written consent
1. Patients who have had previous radiotherapy and/or chemotherapy
2. Patients with creatinine clearance less than 60 ml/min
3. Patients with a previous or concurrent second malignancy, except for basal cell skin cancer
4. Patients with any other major systemic illness
5. Impaired respiratory function i.e. shortness of breath on minimal exertion or hypoxia at rest, transfer coefficient for carbon monoxide (KCO), total lung capacity (TLC), forced expiratory volume in one second (FEV1) less than or equal to 60% predicted
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pulmonary toxicity, as confirmed by central radiological review of CT scans at 12 weeks after starting treatment
- Secondary Outcome Measures
Name Time Method <br> 1. CT scan changes at 6 weeks<br> 2. Quality of life<br> 3. Changes in respiratory function tests<br> 4. Treatment response<br> 5. Progression-free and overall survival<br>