IGCCCG Good Prognosis Germ Cell Tumours Cancer Germ cell tumours
Conditions
Interventions
Day 2, 8, 15 short (30 minute) versus day 1, 2, 3 long (72 hours) infusion bleomycin.
In addition to standard care for patients on chemotherapy, which includes biochemical and radiolog
Sponsors
Barts and The London NHS Trust (UK)
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pulmonary toxicity, as confirmed by central radiological review of CT scans at 12 weeks after starting treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. CT scan changes at 6 weeks 2. Quality of life 3. Changes in respiratory function tests 4. Treatment response 5. Progression-free and overall survival | — |
Countries
United Kingdom
Outcome results
None listed