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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2015-10-31

Brief Summary

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

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Detailed Description

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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

Conditions

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Renal Cell Carcinoma Pulmonary Metastases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Sunitinib

one year adjuvant treatment with sunitinib

Group Type ACTIVE_COMPARATOR

Sunitinib

Intervention Type DRUG

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

Placebo

one year treatment with placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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Sunitinib

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Other Intervention Names

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adjuvant Treatment Plazebo

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No