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

NCT01216371 | Unknown Phase 2 DMC

• 2 other identifiers: AN 20/042008-007609-36
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 11

Brief Summary

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

Conditions

Renal Cell Carcinoma; Pulmonary Metastases

Keywords

carcinoma; metastases; renal; lung

Outcome Measures

Primary Outcomes (1)

• 2 year relapse-free survival

  5 years

Secondary Outcomes (4)

• perioperative mortality and morbidity

  5 years

• Side effect of adjuvant therapy

  5 years

• Quality of Life of the Patient

  5 years

• Overall Survival

  5 years

Study Arms (2)

Sunitinib

ACTIVE COMPARATOR

one year adjuvant treatment with sunitinib

Drug: Sunitinib

Placebo

PLACEBO COMPARATOR

one year treatment with placebo

Drug: Placebo

Interventions

Sunitinib DRUG

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

Also known as: adjuvant Treatment

Sunitinib

Placebo DRUG

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

Also known as: Plazebo

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>/= 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Association of Urologic Oncology (AUO): lead
• University Hospital, Essen: collaborator

Study Sites (11)

Universitätsmedizin Charité Berlin

Berlin, 10117, Germany

NOT YET RECRUITING

Franziskus Krankenhaus

Berlin, 10787, Germany

NOT YET RECRUITING

Helios Klinikum Emil von Behring

Berlin, 14165, Germany

NOT YET RECRUITING

university hospital of Düsseldorf

Düsseldorf, 40255, Germany

RECRUITING

university hospital of Essen

Essen, 45122, Germany

RECRUITING

Ruhrlandklinik Department of Thoracic Surgery

Essen, 45239, Germany

NOT YET RECRUITING

university hospital of Freiburg

Freiburg im Breisgau, 79106, Germany

RECRUITING

university Hospital of Heidelberg

Heidelberg, 69119, Germany

RECRUITING

urological hospital of Maria Hilf Krankenhaus Krefeld

Krefeld, 47805, Germany

RECRUITING

Hospital of Großhadern

München, 81377, Germany

NOT YET RECRUITING

Dr.-Horst-Schmidt-Kliniken GmbH

Wiesbaden, 65199, Germany

RECRUITING

MeSH Terms

Conditions

Carcinoma, Renal Cell; Carcinoma; Neoplasm Metastasis

Interventions

Sunitinib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Susanne Krege, Priv. Doz. Dr. med.

  urological hospital of Maria Hilf Krankenhaus Krefeld

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Susanne Krege, Priv. Doz. Dr. med.

CONTACT

02 151 / 334-23 81

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Priv. Doz. Dr. med. Susanne Krege, urological hospital of Maria Hilf Krankenhaus Krefeld

Study Record Dates

• First Submitted: October 6, 2010
• First Posted: October 7, 2010
• Study Start: October 1, 2010
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: February 13, 2012

Record last verified: 2012-02

Locations

DE (11)