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Evaluate the Efficacy of Sorafenib in Renal Cell Carcinoma Patients After a Radical Resection of the Metastases

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01444807
Recruitment Status : Active, not recruiting
First Posted : October 3, 2011
Last Update Posted : September 17, 2021
Information provided by (Responsible Party):
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Brief Summary:
Evaluate the efficacy and tolerability of sorafenib in RCC patients underwent to metastasectomy

Condition or disease Intervention/treatment Phase
Metastatic Renal Cell Carcinoma Drug: sorafenib Phase 2

Detailed Description:

Advanced RCC presents poor prognosis, because its pathogenesis is not clearly understood. However, up-regulation of the Ras pathway is thought to play a role.

VEGF expression could represent independent prognostic factors for survival possibly linking expression of this protein with clinical outcome.

Sorafenib is a potent inhibitor of both Raf-kinase and VEGF R2 signalling The anti-tumoral activity of Sorafenib was clearly demonstrated in phase III trial regarding advanced pretreated RCC.

Surgical removal of metastatic disease could potentially increase the disease control rate.

Particularly in patients with a disease free interval post nephrectomy of at least 1 year, with one small metastatic lesion, metastasectomy could represents an important therapeutic approach.

After a radical resection of the metastatic disease is unclear if an anti-tumoral systemic therapy may increase patient survival.

In summary, both the preclinical and clinical data support further evaluation of Sorafenib in RCC patients.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 132 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Open Label, Multicenter Phase 2 Study, to Evaluate the Efficacy of Sorafenib in Patients With Advanced Renal Cell Carcinoma (RCC) After a Radical Resection of the Metastases
Study Start Date : December 2011
Actual Primary Completion Date : March 2017
Estimated Study Completion Date : March 2022

Arm Intervention/treatment
Experimental: Sorafenib
Active Arm
Drug: sorafenib
sorafenib 400 mg bid
Other Name: Nexavar (Bayer Health Care - Leverkusen - Germany)

No Intervention: Best Supportive Care

Primary Outcome Measures :
  1. Recurrence Free Survival [ Time Frame: December 2011 - December 2014 (3 years) ]
    Efficacy of Sorafenib compared with BSC, in RCC patients that have undergone radical resection of recurrent metastatic disease, after prior nephrectomy. The primary efficacy endpoint is Recurrence Free Survival (RFS),

Secondary Outcome Measures :
  1. Overall Survival [ Time Frame: December 2011 - December 2014 (3 years) ]
  2. Safety Profile [ Time Frame: December 2011 - December 2014 (3 years) ]
    Physical examination, vital signs, Red blood count: haemoglobin, hematocrit, platelet count, white blood cell count. WBC should include differential neutrophil, lymphocyte, monocyte, basophil and eosinophil counts. Electrolyte panel: sodium, potassium, chloride and corrected calcium.Chemistry panel: AST, ALT, bilirubin, alkaline phosphatase, uric acid, total protein, albumin, calcium, lipase, amylase, phosphate, LDH, glucose, creatinine,BUN, and bicarbonate. Coagulation panel: PT, PT-INR, PTT. Urinalysis, Adverse event

  3. Vascular endothelial growth factors (VEGF) levels in BSC and Sorafenib arm. [ Time Frame: December 2011 - December 2014 (3 years) ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Age ≥ 18 years
  • Patients with cytological or histological diagnosis of Renal Cell Carcinoma (RCC)
  • Absence of residual lesions following surgical removal of metastatic disease. Assessment must be performed by CT-scan or MRI
  • Histologically proven disease free margins of resected surgical specimen
  • No more than three months from radical resection on metastases.
  • ECOG Performance Status of 0 or 2
  • Life expectancy of at least 12 weeks.
  • Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to screening:
  • Hemoglobin > 9.0 g/dl
  • Absolute neutrophil count (ANC) >1,500/mm3
  • Platelet count 100,000/ml
  • Total bilirubin < 1.5 times the upper limit of normal
  • ALT and AST < 2.5 x upper limit of normal (< 5 x upper limit of normal for patients with liver involvement of their cancer)
  • Alkaline phosphatase 4 x ULN
  • PT-INR/PTT < 1.5 x upper limit of normal [Patients who are being therapeutically anticoagulated with an agent such as coumadin or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in these parameters exists.] For patients on warfarin, close monitoring of at least weekly evaluations will be performed, until INR is stable based on a measurement at pre-dose, as defined by the local standard of care.
  • Serum creatinine < 1.5 x upper limit of normal
  • Amylase and lipase <1.5 X upper limit of normal
  • Signed informed consent must be obtained prior to any study specific procedures


  • Prior systemic treatment for metastatic RCC. It is allowed an adjuvant or neoadjuvant therapy before or after nephrectomy if stopped at least 6 months before the resection of metastatic lesion/s.
  • History of cardiac disease: congestive heart failure >NYHA class 2; active CAD (MI more than 6 mo prior to study entry is allowed); cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted) or uncontrolled hypertension (>= 160 mmHg systolic and/or 90 mmHg diastolic).
  • History of HIV infection or chronic hepatitis B or C
  • Active clinically serious infections (> grade 2 NCI-CTC version 3.0)
  • Symptomatic metastatic brain or meningeal tumors unless the patient is > 6 months from definitive therapy, has a negative imaging study within 4 weeks of study entry and is clinically stable with respect to the tumor at the time of study entry. Also the patient must not be undergoing acute steroid therapy or taper (chronic steroid therapy is acceptable provided that the dose is stable for one month prior to and following screening radiographic studies)
  • Patients with seizure disorder requiring medication (such as steroids or anti-epileptics)
  • History of organ allograft
  • Patients with evidence or history of bleeding diathesis
  • Patients undergoing renal dialysis
  • History of other disease, metabolic dysfunction, physical examination finding or clinical laboratory finding giving reasonable suspicion of a disease condition that contraindicates use of an investigational drug or patient at high risk from treatment complications
  • Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (Ta, Tis & T1) or any cancer curatively treated > 3 years prior to study entry.
  • Anticancer chemotherapy or immunotherapy during the study or within 4 weeks of study entry.
  • Radiotherapy during study or within 3 weeks of start of study drug.
  • Major surgery within 4 weeks of start of study
  • Autologous bone marrow transplant or stem cell rescue within 4 months of study
  • Use of biologic response modifiers, such as G-CSF, within 3 week of study entry. (G-CSF and other hematopoietic growth factors may be used in the management of acute toxicity such as febrile neutropenia when clinically indicated or at the discretion of the investigator, however they may not be substituted for a required dose reduction.) (Patients taking chronic erythropoietin are permitted provided no dose adjustment is undertaken within 2 months prior to the study or during the study)
  • Investigational drug therapy outside of this trial during or within 4 weeks of study entry
  • Prior exposure to the study drug.
  • Pregnant or breast-feeding patients. Women of childbearing potential must have a negative pregnancy test performed within 7 days of the start of treatment. Both men and women enrolled in this trial must use adequate barrier birth control measures during the course of the trial and two weeks after the completion of trial.
  • Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
  • Any condition that is unstable or could jeopardize the safety of the patient and their compliance in the study
  • Patients unable to swallow oral medications

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01444807

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Istituto Tumori Milano
Milan, Mi, Italy, 20156
Cinzia Ortega
Alba, Italy
Alessandra Bearz
Aviano, Italy
Alfredo Berruti
Brescia, Italy
Saverio Cinieri
Brindisi, Italy
Francesco Atzori
Cagliari, Italy
Rodolfo Passalaqua
Cremona, Italy
Francesco Di Costanzo
Firenze, Italy
Vincenzo Emanuele Chiuri
Lecce, Italy
Alessandra Mosca
Novara, Italy
Vittorio Gebbia
Palermo, Italy
Enrico Cortesi
Roma, Italy
Francesco Cognetti
Roma, Italy
Franco Morelli
San Giovanni Rotondo, Italy
Sponsors and Collaborators
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
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Study Chair: Giuseppe Procopio, MD Istituto Tumori Milano
Additional Information:
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Responsible Party: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano Identifier: NCT01444807    
Other Study ID Numbers: GP1
First Posted: October 3, 2011    Key Record Dates
Last Update Posted: September 17, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano:
metastatic renal cell carcinoma
Additional relevant MeSH terms:
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Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action