Clinical trial to assess the importance of nephrectomy
- Conditions
- Metastatic renal cell carcinoma, clear cell carcinoma (the most common type of renal cell carcinoma).CancerMalignant neoplasm of kidney, except renal pelvis
- Registration Number
- ISRCTN19562321
- Lead Sponsor
- HS Greater Glagsow and Clyde (UK)
- Brief Summary
2018 Results article in https://www.ncbi.nlm.nih.gov/pubmed/29860937 results (added 10/04/2019)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 450
1. Age = 18 years
2. Eastern Cooperative Oncology Group (ECOG) Performance Status 0 - 1
3. Biopsy (primary tumour or metastases) confirming the diagnosis of clear cell carcinoma alone or preponderant
4. Documented metastatic disease
5. Absence of prior systemic treatment for kidney cancer including anti angiogenic (AA)
6. Tumour amenable to nephrectomy (partial or total) in the opinion of the patient?s urologist. Patients presenting with an inferior vena cava thrombosis can be included.
7. Patients for which the indication of Sunitinib is considered according to the recommendations rules given by national health authorities of participating countries. The prescription of Sunitinib in the circumstances of the study is considered as a standard treatment
8. Platelets 100 x 109/L, haemoglobin > 9 g/dl, neutrophils >1.5 x 109/L
9. Bilirubin < 2 mg/dL, aspartate transaminase (ASAT) and alanine transaminase (ALAT), 2.5 times the upper normal limit (UNL) or 5 times UNL for patients with liver metastases
10. Patients of child bearing age should use contraceptive methods
11. Patient able to follow the procedures outlined in the protocol as far as the planning of visits and examinations are concerned
12. Life expectancy = 3 months
13. Written informed consent
1. Prior systemic treatment for kidney cancer (including anti angiogenic)
2. Bilateral kidney cancer
3. Pregnant or breast feeding women
4. Acute coronary syndrome or episode of myocardial infarction or severe or unstable angina within the last 6 months as well as severe diabetes with severe peripheral arteriopathy or deep phlebitis or arterial thrombosis within the last 3 months
5. Anticoagulant therapy in treatment dose
6. Medical, general or psychiatric difficulties which, in the opinion of the Investigator, would make it inappropriate for trial entry
7. Brain metastases
8. Previous history of gastric disease or of malabsorption compromising the absorption of Sunitinib
9. Experimental treatment within the 28 days preceding inclusion
10. Other cancer within the previous 5 years [except for insitu skin carcinoma and treated localised prostate cancer with undetectable Prostate-specific antigen (PSA)]
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate the importance of initial nephrectomy for the subsequent survival of patients with metastatic renal cell carcinoma treated with sunitinib. This is calculated by the time between the date of randomisation and the date of death, irrespective of cause of death.
- Secondary Outcome Measures
Name Time Method <br> 1. Tumour response<br> 2. Progression free survival- Progression-free survival is calculated by the time between the date of randomisation and the date of progression or the date of initiating second-line treatment. Patients who have died from other causes are recorded on the date of death. Patients who are alive and progression-free when last heard of are recorded on the date of the last visit.<br> 3. The percentage of patients who cannot start Sunitinib treatment within 6 weeks postoperatively on Arm A (nephrectomy + Sunitinib)<br> 4. The need to perform nephrectomy in Arm B (Sunitinib alone)<br> 5. Postoperative morbidity is evaluated using the Clavien scales<br> 6. Postoperative mortality is evaluated by the percentage of deaths within the 30 days following nephrectomy.<br> 7. Tolerability, particularly changes in renal function over time is evaluated by the NCI-CTC v3 scales<br>