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

Renal Cell Carcinoma Clinical Trial

— SMAT  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01216371
• Other study ID #: AN 20/04
• Secondary ID: 2008-007609-36
• Status: Recruiting
• Phase: Phase 2
• First received: October 6, 2010
• Last updated: February 10, 2012
• Start date: October 2010
• Est. completion date: October 2015

Study information

• Verified date: February 2012
• Source: Association of Urogenital Oncology (AUO)
• Contact: Susanne Krege, Priv. Doz. Dr. med.
• Phone: 02 151 / 334-23 81
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• Lung Neoplasms
• Neoplasm Metastasis
• Pulmonary Metastases
• Renal Cell Carcinoma

Intervention

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

Locations

Country	Name	City	State
Germany	Franziskus Krankenhaus	Berlin
Germany	Helios Klinikum Emil von Behring	Berlin
Germany	Universitätsmedizin Charité Berlin	Berlin
Germany	university hospital of Düsseldorf	Düsseldorf
Germany	Ruhrlandklinik Department of Thoracic Surgery	Essen
Germany	university hospital of Essen	Essen
Germany	university hospital of Freiburg	Freiburg
Germany	university Hospital of Heidelberg	Heidelberg
Germany	urological hospital of Maria Hilf Krankenhaus Krefeld	Krefeld
Germany	Hospital of Großhadern	München
Germany	Dr.-Horst-Schmidt-Kliniken GmbH	Wiesbaden

Sponsors (2)

Lead Sponsor	Collaborator
Association of Urogenital Oncology (AUO)	University Hospital, Essen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	2 year relapse-free survival		5 years	Yes
Secondary	perioperative mortality and morbidity		5 years	No
Secondary	Side effect of adjuvant therapy		5 years	No
Secondary	Quality of Life of the Patient		5 years	Yes
Secondary	Overall Survival		5 years	No