Topic: National Cancer Research Network
Conditions
Interventions
The sample size calculation is based on a Simon optimal two-stage design using a type I error level of 5% and power of 80%. We assume the treatment to be acceptable if less than 1% (P1=0.99) of patien
Sponsors
Royal Marsden NHS Foundation Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histologically confirmed metastatic renal cell carcinoma 2. At least one site of disease outside the kidney measurable per Response Evaluation Criteria In Solid Tumors (RECIST) 3. Scheduled to undergo nephrectomy as part of treatment plan 4. No prior systemic therapy for renal cell carcinoma 5. Male or female, 18 years of age or older 6. Life expectancy of 12 weeks or greater 7. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 8. Serum aspartate transaminase (AST) serum alanine transaminase (ALT) = 2.5 x upper limit of normal (ULN), or AST and ALT = 5 x ULN if liver function abnormalities are due to underlying malignancy 9. Total serum bilirubin = 1.5 x ULN 10.Serum creatinine = 1.5 x ULN 11. Absolute neutrophil count (ANC) = 1.5 x109/L 12. Platelets = 100 x109/L 13. Haemoglobin = 9.0 g/dL 14. Prothrombin time (PT) = 1.5 x ULN 15. Signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all pertinent aspects of the trial prior to enrolment 16. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures; Target Gender: Male & Female ; Lower Age Limit 18 no age limit or unit specified
Exclusion criteria
Exclusion criteria: 1. Intracranial disease, unless there has been radiological evidence of stable intracranial disease > 6 months. In the case of a solitary brain metastasis, evidence of a disease-free interval of at least 3 months post surgery. All patients previously treated for brain metastases must be stable off corticosteroid therapy for at least 28 days 2. Need for nephrectomy to relieve symptoms relating to the primary tumour or for emergency nephrectomy 3. Diagnosis of any second malignancy within the last 5 years, except for adequately treated basal cell carcinoma, squamous cell skin cancer, or in situ cervical cancer 4. Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) related illness 5. Pregnancy or breastfeeding. Female patients must be surgically sterile or be postmenopausal, or must agree to use effective contraception during the period of therapy. All female patients with reproductive potential must have a negative pregnancy test (serum or urine) prior to enrolment. Male patients must be surgically sterile or must agree to use effective contraception during the period of therapy 6. Current signs or symptoms of severe progressive or uncontrolled hepatic, haematologic, gastrointestinal, endocrine, pulmonary or cardiac disease other than directly related to renal cell cancer (RCC)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Outcome; Timepoint(s): safety of pre-operative and post-operative everolimus therapy in 19 evaluable patients | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Efficacy [response rate (RR), progression-free survival (PFS), overall survival (OS)] 2. Toxicity (CTC) 3. Biomarkers (exploratory qualitative) | — |
Countries
United Kingdom
Outcome results
None listed