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Renal Cell CarcinomaPhase 2SMATNCT01216371

Resection of Pulmonary Metastasis in Clear Cell Renal Cell Carcinoma +/-Adjuvant Sunitinib Therapy (SMAT)

A Phase 2 study testing Sunitinib in people with Renal Cell Carcinoma and Pulmonary Metastases, run by Association of Urologic Oncology (AUO) at 11 sites in Germany.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The aim ist to identify biomarkers in the blood, to indicate early response or early treatment resistance. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Renal Cell Carcinoma, Pulmonary Metastases
What is being tested?
Sunitinib
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
11 sitesGermany
Study dates
Oct 2010to Oct 2015
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • >/= 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

Who cannot join

  • 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
Show all 19Show fewer
  • 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

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

Germany11 sites

  • Universitätsmedizin Charité Berlin

    Berlin, 10117

  • Franziskus Krankenhaus

    Berlin, 10787

  • Helios Klinikum Emil von Behring

    Berlin, 14165

  • university hospital of Düsseldorf

    Düsseldorf, 40255

  • university hospital of Essen

    Essen, 45122

  • Ruhrlandklinik Department of Thoracic Surgery

    Essen, 45239

  • university hospital of Freiburg

    Freiburg im Breisgau, 79106

  • university Hospital of Heidelberg

    Heidelberg, 69119

  • urological hospital of Maria Hilf Krankenhaus Krefeld

    Krefeld, 47805

  • Hospital of Großhadern

    München, 81377

  • Dr.-Horst-Schmidt-Kliniken GmbH

    Wiesbaden, 65199

Other trials in Germany

About this study

Official title: Prospektiv Randomisierte Multizentrische Phase II-Studie Zur Metastasenresektion Von Lungenfiliae (Poor-prognosis) Beim Klarzelligen Nierenzellkarzinom +/- Adjuvante Sunitinibtherapie über 1 Jahr SMAT - AN 20/04 Der AUO

The aim ist to identify biomarkers in the blood, to indicate early response or early treatment resistance.

Read the detailed description

Prospective randomized multi-center Phase II trial for resection of metastases from pulmonary metastases (poor prognosis) in clear cell renal cell carcinoma + / - adjuvant sunitinib therapy over one year

Being tested
Sunitinib, Placebo
Keywords
carcinoma, metastases, renal, lung
Medical subject headings
Carcinoma, Renal Cell, Carcinoma, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SunitinibDrug

    Also called adjuvant Treatment

    one-year adjuvant Treatment with Sunitinib, schematic (4:2): 4 weeks (28) 50 mg(milligram) daily, 2 weeks (14) break

  • PlaceboDrug

    Also called Plazebo

    one-year Treatment, schematic (4:2): 4 weeks (28) 50 mg(milligram) daily, 2 weeks (14) break,

Study groups in NCT01216371
Study groupRoleWhat they receive
SunitinibActive comparatorone year adjuvant treatment with sunitinib
Receives: Drug: Sunitinib
PlaceboPlacebo comparatorone year treatment with placebo
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 2 year relapse-free survival

    Measured: 5 years

Secondary outcomes (4)

  1. perioperative mortality and morbidity

    Measured: 5 years

  2. Side effect of adjuvant therapy

    Measured: 5 years

  3. Quality of Life of the Patient

    Measured: 5 years

  4. Overall Survival

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Oct 2010 (estimated)
  2. Study startOct 2010
  3. Primary completionOct 2015
  4. Study completionOct 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01216371
Sponsor's protocol ID
AN 20/04
Other IDs
2008-007609-36, 2008
Acronym
SMAT
Status last verified
Feb 2012
First submitted
6 Oct 2010
Last updated
25 Aug 2026
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Sunitinib in people with Renal Cell Carcinoma and Pulmonary Metastases, run by Association of Urologic Oncology (AUO) at 11 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early. Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

2 year relapse-free survival (time frame: 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01216371.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2026.

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