Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2025-12-24 @ 11:40 PM
NCT ID:
NCT02535351
Eligibility Criteria:
Inclusion Criteria:
* Written informed consent
* ECOG Performance Status 0-1
* Favorable or intermediate MSKCC or Heng risk score
* Biopsy (primary tumour or metastases) confirming the diagnosis of predominantly clear cell RCC
* 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.)
* Tumour suitable to nephrectomy in the opinion of the urologist. Patients with Inferior vena cava thrombosis can be included
* Documented metastatic disease (CT scan or MRI)
* Life expectancy \> or = 24 weeks
* Up to three different metastatic sites
* ≥ 3 metastatic lesions
* Platelets \> 100,000/ml
* Haemoglobin \> 9.0 g/dl
* neutrophils \>1,500/mm3
* Bilirubin \< or = 2 mg/dl, except for patients affected by Gilbert's syndrome
* AST and ALT \< or = 2.5 times the UNL
* Serum albumin \> the LNL
* Patients of childbearing age should use contraceptive methods during the study
Exclusion Criteria:
* Prior surgery or systemic treatment for mRCC
* Bilateral RCC
* Brain and liver metastases
* Non-clear-cell histology
* Poor prognosis as defined by MSKCC or Heng criteria
* Documented widespread disease (\> or =4 metastatic organ sites)
* Oligometastatic disease suitable of metastasectomy (\<3 lesions confined at one organ site)
* Symptomatic primary tumour at presentation
* High surgical risk in the opinion of the urologist
* 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
* Symptoms at presentation due to metastases
* Clinical stage T4 disease
* History of malabsorption syndrome
* Pregnant or breastfeeding women
* Concomitant cardiac disorders: cardiac failure NYHA\> 2; Acute coronary syndrome or myocardial infarction or severe or unstable angina within the last 6 months as well as uncontrolled hypertension (sistolic\>160, diastolic\>90), arrhytmia requiring treatment (except for beta blockers or digossin)
* Uncontrolled diabetes
* Deep phlebitis not treated with LMWH or arterial thrombosis within the last 6 months
* HIV infection
* Active infections (\> Grade 2 NCI-CTC v.3.0)
* Other cancer within the previous 5 years (except for in situ skin carcinoma, superficial bladder Ta, Tis, T1 and carcinoma of the cervix or every cancer with curative treatment within 5 years)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT02535351
Study Brief:
Protocol Section:
NCT02535351