Immediate Surgery or Surgery After Sunitinib Malate in Treating Patients With Metastatic Kidney Cancer

NCT01099423 | Unknown Phase 3

• 3 other identifiers: EORTC-30073EU-21022PFIZER-EORTC-30073
• Study Type: interventional
• Target: 99
• Locations: 5 countries
• Sites: 29

Brief Summary

RATIONALE: Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving sunitinib malate before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving sunitinib malate after surgery may kill any tumor cells that remain after surgery. It is not yet known whether undergoing immediate surgery or surgery after sunitinib malate is more effective in treating patients with metastatic kidney cancer. PURPOSE: This randomized phase III trial is studying immediate surgery to see how well it works compared with surgery after sunitinib malate in treating patients with metastatic kidney cancer.

Conditions

Kidney Cancer

Keywords

clear cell renal cell carcinoma; stage IV renal cell cancer

Outcome Measures

Primary Outcomes (1)

• Overall progression-free survival

Secondary Outcomes (4)

• Overall survival

• Morbidity

• Overall response to treatment in the deferred nephrectomy arm including the proportion of patients who become unresectable

• Effect of nephrectomy on early progression in both arms

Study Arms (2)

Immediate nephrectomy

ACTIVE COMPARATOR

Surgery followed by Sunitinib

Genetic: gene expression analysis; Other: biologic sample preservation procedure; Other: laboratory biomarker analysis; Procedure: therapeutic conventional surgery

Deferred nephrectomy

EXPERIMENTAL

Sunitinib (3 cycles) followed by surgery followed by Sunitinib

Procedure: timing of surgery; Genetic: gene expression analysis; Other: biologic sample preservation procedure; Other: laboratory biomarker analysis

Interventions

timing of surgery PROCEDURE

Deferred nephrectomy

gene expression analysis GENETIC

Deferred nephrectomy; Immediate nephrectomy

biologic sample preservation procedure OTHER

Deferred nephrectomy; Immediate nephrectomy

laboratory biomarker analysis OTHER

Deferred nephrectomy; Immediate nephrectomy

therapeutic conventional surgery PROCEDURE

Immediate nephrectomy

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed renal cell cancer (RCC) * Clear-cell subtype with a resectable asymptomatic in situ primary * Asymptomatic primary is defined as the absence of symptoms\* which can be exclusively assigned to the primary tumor such as flank pain and/or gross hematuria necessitating blood transfusion NOTE: \*Para-neoplastic symptoms cannot be assigned to the primary tumor alone in metastatic disease, they are not included in this definition. * No symptomatic primary tumor necessitating nephrectomy * Resectable primary tumor * Bulky locoregional lymph node metastases larger than the primary tumor allowed provided resectability of the lymph nodes is surgically feasible * Metastatic RCC * Distant metastases are not completely resectable at the time of surgery or during an additional intervention * No multiple distant lesions at one site * No bone-only metastases * Measurable disease, both primary and metastatic, according to RECIST 1.1 criteria * Planning to receive sunitinib malate as background therapy * Patients with \> 3 of the following surgical risk factors are not eligible: * Serum albumin CTCAE v 4.0 grade 2 or worse * Serum LDH \> 1.5 times upper limit of normal * Liver metastases * Symptoms at presentation due to metastases * Retroperitoneal lymph node involvement * Supra-diaphragmatic lymph node involvement * Clinical stage T3 or T4 disease * No clinical signs of CNS involvement PATIENT CHARACTERISTICS: * See Disease Characteristics * WHO performance status 0-1 * Life expectancy \> 3 months * WBC \> 3.0 x 10\^9/L * Platelet count \> 100 x 10\^9/L * Hemoglobin \> 10.0 g/dL * PT/PTT or INR ≤ 1.2 times upper limit of normal (ULN) * Bilirubin ≤ 1.5 times ULN * ALT ≤ 2.5 times ULN (≤ 5 times ULN if liver lesions) * Serum calcium \< 10.0 mg/dL * Calculated or measured creatinine clearance \> 30 mL/min * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception 2 weeks before and during study treatment * LVEF normal by MUGA scan or ECHO * 12-lead ECG normal * No serious cardiac illness (myocardial infarction and/or treatable or untreatable angina pectoris not responding to treatment) within the past 12 months * No uncontrolled, high BP (≥ 150/100 mm Hg) despite optimal medical therapy * No current pulmonary disease * No active or uncontrolled infections, serious illnesses, malabsorption syndrome, or medical conditions, including patients with a history of chronic alcohol abuse, hepatitis, HIV, and/or cirrhosis * No malignancies within the past 5 years except renal cell carcinoma, basal or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, resected incidental prostate cancer staged pT2 with Gleason Score ≤ 6 and postoperative PSA \< 0.5 ng/mL, or patients with any history of malignancies who are disease-free for more than 5 years * No psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule PRIOR CONCURRENT THERAPY: * Prior local radiotherapy for bone lesions allowed * No prior systemic therapy for metastatic RCC * No prior partial or total nephrectomy * No concurrent systemic corticosteroid and/or other immunosuppressive systemic therapies * No concurrent radiotherapy, except palliative radiotherapy * No concurrent participation in another clinical trial testing treatments for any disease including renal cell carcinoma * No other concurrent investigational or systemic therapy for metastatic RCC

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• European Organisation for Research and Treatment of Cancer - EORTC: lead
• Wales Cancer Trials Unit: collaborator
• Canadian Urologic Oncology Group: collaborator
• Institute of Cancer Research, United Kingdom: collaborator

Study Sites (29)

Onze Lieve Vrouw Ziekenhuis

Aalst, Belgium

Location

Cliniques Universitaires St. Luc

Brussels, Belgium

Location

Hôpitaux Universitaires Bordet-Erasme - Institut Jules Bordet

Brussels, Belgium

Location

Universitair Ziekenhuis Gent

Ghent, Belgium

Location

Virga Jesse Hospital

Hasselt, Belgium

Location

AZ Groeninghe - Campus Loofstraat

Kortrijk, Belgium

Location

AZ Damiaan - Campus Sint-Jozef

Ostend, Belgium

Location

Queen Elizabeth II Health Sciences Centre

Halifax, Nova Scotia, Canada

Location

CHUM - Pavillon Saint-Luc

Montreal, Quebec, Canada

Location

Montreal General Hospital

Montreal, Canada

Location

The Ottawa Hospital, The Integrated Cancer Program- General Campus

Ottawa, Canada

Location

University Health Network - Oci / Princess Margaret Hospital

Toronto, Canada

Location

Diamond Health Care Centre

Vancouver, Canada

Location

San Camillo Forlanini Hospitals

Roma, Italy

Location

Jeroen Bosch Ziekenhuis

's-Hertogenbosch, Netherlands

Location

Academisch Medisch Centrum - Universiteit van Amsterdam

Amsterdam, Netherlands

Location

The Netherlands Cancer Institute-Antoni Van Leeuwenhoekziekenhuis

Amsterdam, Netherlands

Location

Vrije Universiteit Medisch Centrum

Amsterdam, Netherlands

Location

University Medical Center Groningen

Groningen, Netherlands

Location

Academisch Ziekenhuis Maastricht

Maastricht, Netherlands

Location

Radboud University Nijmegen Medical Centre

Nijmegen, Netherlands

Location

Universitair Medisch Centrum - Academisch Ziekenhuis

Utrecht, Netherlands

Location

Royal United Hospital

Bath, United Kingdom

Location

University Hospitals Bristol NHS Foundation Trust - Bristol Haematology And Oncology Centre

Bristol, United Kingdom

Location

St. James'S University Hospital

Leeds, United Kingdom

Location

Barts and The London NHS Trust - St. Bartholomew'S Hospital

London, United Kingdom

Location

Imperial College Healthcare NHS Trust - Charing Cross Hospital

London, United Kingdom

Location

Christie NHS Foundation Trust

Manchester, United Kingdom

Location

Singelton Hospital

Swansea, United Kingdom

Location

Related Publications (3)

• Bex A, Mulders P, Jewett M, Wagstaff J, van Thienen JV, Blank CU, van Velthoven R, Del Pilar Laguna M, Wood L, van Melick HHE, Aarts MJ, Lattouf JB, Powles T, de Jong Md PhD IJ, Rottey S, Tombal B, Marreaud S, Collette S, Collette L, Haanen J. Comparison of Immediate vs Deferred Cytoreductive Nephrectomy in Patients With Synchronous Metastatic Renal Cell Carcinoma Receiving Sunitinib: The SURTIME Randomized Clinical Trial. JAMA Oncol. 2019 Feb 1;5(2):164-170. doi: 10.1001/jamaoncol.2018.5543.

  PMID: 30543350 DERIVED

• Leon L, Garcia-Figueiras R, Suarez C, Arjonilla A, Puente J, Vargas B, Mendez Vidal MJ, Sebastia C. Recommendations for the clinical and radiological evaluation of response to treatment in metastatic renal cell cancer. Target Oncol. 2014 Mar;9(1):9-24. doi: 10.1007/s11523-013-0304-7. Epub 2013 Dec 12.

  PMID: 24338498 DERIVED

• Winquist E, Rodrigues G. Open clinical uro-oncology trials in Canada. Can J Urol. 2012 Dec;19(6):6587-91. No abstract available.

  PMID: 23228299 DERIVED

MeSH Terms

Conditions

Kidney Neoplasms; Carcinoma, Renal Cell

Interventions

Gene Expression Profiling

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Genetic Techniques; Investigative Techniques

Study Officials

• Axel Bex

  The Netherlands Cancer Institute

  STUDY CHAIR

• John B.A.G. Haanen

  The Netherlands Cancer Institute

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2010
• First Posted: April 7, 2010
• Study Start: April 1, 2010
• Primary Completion: April 1, 2016
• Study Completion: May 1, 2017
• Last Updated: February 8, 2017

Record last verified: 2017-02

Locations

BE (7); IT (1); NL (8); GB (7); CA (6)