Study of Axitinib for Downstaging Large Renal Tumors Not Primarily Suitable for Partial Nephrecto… (NCT02597322) | Clinical Trial Compass
CompletedPhase 2
Study of Axitinib for Downstaging Large Renal Tumors Not Primarily Suitable for Partial Nephrectomy (AXIPAN)
France21 participantsStarted 2012-02
Plain-language summary
Axitinib (AXITINIB) is an oral, potent, and selective inhibitor of vascular endothelial growth factor receptors 1, 2, and 3 which has achieved objective response rate of 44.2% in phase II study in cytokine-refractory metastatic renal-cell cancer patients.
Pre-surgical treatment with Axitinib could allow a substantial proportion of patients with large organ confined tumors to benefit from NSS.
The Objective is to determine the efficacy of Axitinib administered prior to surgery in patients with large organ confined tumors not primarily suitable for NSS (cT2aNoNxM0) for shifting from a radical nephrectomy indication to a nephron sparing procedure.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients must sign IRB/EC-approved informed consent.
* Age ≥ 18
* Histologically proven clear cell RCC (obtained by CT or US guided biopsy)
* cT2a N0NxM0 Renal tumor according to 2009 TNM classification (tumor Ø\> 7cm; ≤ 10 cm)
* No evidence of preexisting uncontrolled hypertension as documented by 2 baseline blood pressure readings taken at least 1 hour apart.
* Normal renal function (MDRD creatinin clearance ≥ 60 ml/min)
* Patients must have adequate organ function defined as: Platelets ≥ 150 x 109/L, hemoglobin \> 9 g/dl, absolute neutrophil count (ANC) \>1.5 x 109/L; Bilirubin \< 2 mg/dL, aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 times the upper limit of normal; Total cholesterol ≤ 9.1 mmol/l and triglyceride level ≤ 4.5 mmol/l
* Urinary protein \<2+ by urine dipstick.
* Patients with reproductive potential must use medically acceptable contraceptive method.
* Beneficiary of a social coverage (except AME)
Exclusion Criteria:
* Patients with \< 50 % clear cell histology
* Evidence of locally advanced disease: cT stage≥T2b, N Stage≥1 or metastatic disease (M1)
* Patients must not be pregnant or lactating.
* Patients must not have uncompensated coronary artery disease or an history of myocardial infarction or severe or unstable angina within the past six months or severe diabetes mellitus with severe arterial peripheral disease or deep venous or arterial thrombosis or embolism with the past 3 months. Patients must not need cur…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The number of patients actually experiencing a partial nephrectomy for a tumor ≤ 7cm
Timeframe: At 6 months after beginning of the treatment