Clinical Trial to Assess the Importance of Nephrectomy (NCT00930033) | Clinical Trial Compass
CompletedPhase 3
Clinical Trial to Assess the Importance of Nephrectomy
France452 participantsStarted 2009-09-09
Plain-language summary
The study compare the standard treatment with nephrectomy + sunitinib to treatment with sunitinib alone without nephrectomy. This study will be the first trial on this competitive context
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* age ≥ 18 years
* ECOG Performance Status 0 - 1
* Biopsy (primary tumour or metastases) confirming the diagnosis of clear cell carcinoma
* Documented metastatic disease
* Absence of prior systemic treatment for kidney cancer including AA
* 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.
* 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.
* Platelets \> or = 100 x 109/L, haemoglobin \>or = 9 g/dl, neutrophils \>or = 1.5 x 109/L;
* Bilirubin \< or = 2 mg/dL, aspartate transaminase (ASAT) and alanine transaminase (ALAT)\< or = 2.5 times the upper normal limit (UNL) or \< or = 5 times UNL for patients with liver metastases
* Patients of child bearing age should use contraceptive methods
* Patient able to follow the procedures outlined in the protocol as far as the planning of visits and examinations are concerned.
* Life expectancy ≥ 3 months
* Written informed consent
* Patient without brain metastases or with radiotherapy or surgery treated brain metastases without progression into 6 weeks and non treated by corticoid
* Patient non treated by anticoagulants excepted HBPM
Exclusion Criteria:
* Prior systemic treatment for k…