Can a year of sunitinib delay kidney Cancer's return after lung surgery?
NCT ID NCT01216371
First seen Aug 25, 2026 · Last updated Aug 26, 2026 · Updated 1 time
Summary
This phase 2 trial investigates whether taking the drug sunitinib for one year after surgical removal of lung metastases can improve relapse-free survival in patients with clear cell kidney cancer. Participants are randomly assigned to receive either sunitinib or a placebo following their surgery. The study also tracks side effects, quality of life, and overall survival, and aims to identify blood biomarkers that may predict early response or resistance to treatment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Sunitinib, an oral drug that blocks blood vessel growth to tumors, taken daily for 4 weeks followed by a 2-week break, for one year after surgery to remove lung metastases.
- What this could lead to
- If effective, this approach could extend the time before kidney cancer returns after lung metastases are surgically removed, potentially improving long-term outcomes.
- What could go wrong
- This is a phase 2 trial with a small number of patients, so results may not be conclusive. Sunitinib can cause side effects like fatigue, high blood pressure, and digestive issues, and may not improve survival for everyone.
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Start date
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Oct 2010
- Finished
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Oct 2015
- Lead sponsor
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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 to 75 years
- 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: * \>/= 2 synchronous or within 24 Months after Nephrectomy occured pulmonary metastases. Patients in whom more back than 2 years of a solitary lung metastasis, bone metastasis or brain metastasis was resected, may also be included in the study. * Aged 18 to 75 years * functionally acceptable surgical risk * Women in conceptional age: negative pregnancy test and adequate contraception * Adequate hematologic, renal, hepatic and coagulation-physiological functions * Amylase/ Lipase \< 1,5 x upper limit of normal * Informing the patient about the study and the present written consent to participate after clarification in accordance with the stipulations of AMG(german drug law), and the principles of GCP ("informed consent") * Patient compliance and geographic proximity to allow adequate follow-up Exclusion Criteria: * Presence of other metastases outside the lung * progress in the 12-week sunitinib therapy before resection of metastases * R1 or R2-finding in resection of metastases * Dialysis after nephrectomy * Previous or existing serious cardiovascular (grade III - IV according to NYHA(New York Heart Association)) disease, active angina pectoris or ischemia, myocardial infarction within previous 6 months , uncontrolled hypertension(RR diastolic 120 mmHg(Millimeters of mercury)) * serious hematopoetic (e.g. serious Bone marrow aplasia), pulmonary, hepatic or renal Disease * Stroke within the previous six months * Patients with poorly controlled diabetes mellitus * Serious bacterial or fungal infections * chronic hepatitis B or C, HIV(human immunodeficiency virus) infection * autoimmune disease * prior organ transplantation * prior autologous bone marrow transplant or stem cell transferred within the last 4 months before study * Neuropsychiatric diseases that affect patient compliance * Manifesto, second malignancy or other malignancy within the past 5 years (except basal cell carcinoma, carcinoma in situ of the cervix, incidental prostate carcinoma, superficial urothelial Ca pTaG1-2 and pT1G1) * Therapy with immunotherapeutic agents including monoclonal antibodies, cytotoxic drugs or hormones (other than bisphosphonates and oral contraceptives) within the last 4 weeks prior to enrollment. Previous use of inhibitors of Ras/Raf-, MEK kinase, AKT kinase and mTOR inhibitors or induction of Farnesyltransferase * Previous use of angiogenesis inhibitors such as VEGF / VEGFR, PDGF / PDGFR and other key molecules of angiogenesis * parallel treatment with rifampicin * Participation in other treatment studies in the last 4 weeks
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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
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Dr.-Horst-Schmidt-Kliniken GmbH
Wiesbaden, 65199, Germany
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Franziskus Krankenhaus
Berlin, 10787, Germany
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Helios Klinikum Emil von Behring
Berlin, 14165, Germany
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Hospital of Großhadern
München, 81377, Germany
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Ruhrlandklinik Department of Thoracic Surgery
Essen, 45239, Germany
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Universitätsmedizin Charité Berlin
Berlin, 10117, Germany
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university Hospital of Heidelberg
Heidelberg, 69119, Germany
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university hospital of Düsseldorf
Düsseldorf, 40255, Germany
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university hospital of Essen
Essen, 45122, Germany
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university hospital of Freiburg
Freiburg im Breisgau, 79106, Germany
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urological hospital of Maria Hilf Krankenhaus Krefeld
Krefeld, 47805, Germany
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Other studies related to the condition(s) this trial covers.
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- Can teaching patients about immunotherapy cut severe side effects?
- Can a drug duo outperform standard care for advanced kidney cancer?
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- Can we predict who needs extra therapy after kidney cancer surgery?