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

Association of Urologic Oncology (AUO)

Status and phase: Unknown; Phase 2

Conditions: Pulmonary Metastases; Renal Cell Carcinoma

Treatments: Drug: Placebo; Drug: Sunitinib

Study type: Interventional

Funder types: Other

Identifiers

NCT01216371

AN 20/04

2008-007609-36 (EudraCT Number)

Details and patient eligibility

About

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

Full 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

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups, including a placebo group

Sunitinib

Active Comparator group

Description:

one year adjuvant treatment with sunitinib

Treatment:

Drug: Sunitinib

Placebo

Placebo Comparator group

Description:

one year treatment with placebo

Treatment:

Drug: Placebo