Prospective randomized multicenter phase II study of pulmonalfiliae metastases (poor-prognosis) in clear cell renal cell carcinoma + / - adjuvant Sunitinibtherapie than 1 year - SMAT - AN 20/04

Phase 2

• Conditions: kidney cancer; C64; C78.0; Malignant neoplasm of kidney, except renal pelvis; Secondary malignant neoplasm of lung

• Registration Number: DRKS00003518
• Lead Sponsor: niversitätsklinikum Essen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01-30
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

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

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
2 year relapse-free survival

Secondary Outcome Measures

Name	Time	Method
- perioperative mortality and morbidity [ Time Frame: 5 years ] <br>- Side effect of adjuvant therapy [ Time Frame: 5 years ] <br>- Quality of Life of the Patient [ Time Frame: 5 years ] <br>- Overall Survival [ Time Frame: 5 years ] [ <br>