Kidney cancer study questions need for surgery in advanced cases
NCT ID NCT00930033
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This phase 3 trial tested whether removing the kidney (nephrectomy) before taking the drug sunitinib helps people with metastatic kidney cancer live longer compared to taking sunitinib alone. 452 patients were randomly assigned to either surgery plus sunitinib or sunitinib only. The main goal was to see if adding surgery improved overall survival.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Sunitinib
- What this could lead to
- If successful, this could show that skipping surgery and using only sunitinib is just as effective, sparing patients from an invasive procedure.
- What could go wrong
- This trial is already completed, so results are known. The study may not apply to all kidney cancer types, and sunitinib has side effects like fatigue and high blood pressure.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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452 people
The number who actually took part.
- Started
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Sep 2009
- Finished
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Oct 2018
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 kidney cancer (including Anti Angiogenic) * Bilateral kidney cancer * Pregnant or breast feeding women * 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 not treated with low molecular weight heparin or arterial thrombosis within the last 3 months * Patients being treated with antivitamin K with curative intent (please note that patients being treated with low molecular weight heparin can be included) * Medical, general or psychiatric difficulties which, in the opinion of the Investigator, would make it inappropriate for trial entry * Symptomatic or untreated brain metastases (patients with brain metastases that have been treated by radiotherapy or surgery and have stable disease within 6 weeks, and are not requiring treatment with corticosteroids can be included) * Previous history of gastric disease or malabsorption, syndrome compromising the absorption of Sunitinib * Experimental treatment within the 28 days preceding inclusion * Other cancer within the previous 5 years (except for insitu skin carcinoma and treated localised prostate cancer with undetectable PSA) * Patient has received treatment with IV biphosphonate
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Hopital Necker
Paris, 75015, France
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Other studies related to the condition(s) this trial covers.
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