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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Dr
Grant
Stewart
Mrs
Kathleen
Riddle
Clear cell renal cell cancer with venous thrombus invasion
This information is provided directly by researchers and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35739300/ (added 29/07/2022)
You can take part if:
Current inclusion criteria as of 11/02/2019:
1. Aged 18 years and over
2. Biopsy-proven clear cell RCC
3. Immediate resection of the primary tumour considered technically possible
4. The patient must be suitable for and willing to undergo nephrectomy surgery
5. The clinical (radiologically determined) stage of the tumour must be into the main renal vein (cT3a, but seen in the main branch of the renal vein leading to but not beyond the vein ostium with the inferior vena cava (IVC)), or the IVC itself either below of above the diaphragm (cT3b or cT3c respectively)
6. Nodal status may be clinically node negative (cN0) on CT, indeterminate (cNx) or clinically node positive on CT (cN1)
7. Non-metastatic (M0) and metastatic (M1) clear cell renal cell patients
8. The patient must have an ECOG performance status of either 0 or 1
9. Urine must contain less than 2 g protein. If urine contains ≥2 g then a 24-h urine collection or urinary protein creatinine ratio (PCR) should be performed and the patient may enter NAXIVA only if urinary protein is <2g per 24 hours or PCR <200mg/mmol.
10. Serum Creatinine ≤1.5xULN or estimated Creatinine clearance ≥30mL/min as calculated using the Cockcroft- Gault (CG) equation.
11. All female patients with reproductive potential must have a negative serum or urine pregnancy test within a maximum of 14 days pri
You may not be able to take part if:
Current exclusion criteria as of 11/02/2019:1. Metastatic patients with poor risk on the Memorial Sloan Kettering Cancer Centre (MSKCC) score and deemed suitable for cytoreductive nephrectomy at time of enrolment2. Other invasive malignancy within the last 2 years. Patients with previous history of malignancies with a negligible risk of metastasis or death and treated with expected curative intent are eligible, for example but not exclusively:2.1. Carcinoma in situ of the cervix.2.2 Basal or squamous cell skin cancer.2.3 Localized low to intermediate risk prostate cancer treated with curative intent and absence of prostate specific antigen (PSA) relapse; or prostate cancer (Stage T1/T2a, Gleason ≤6 and PSA 3. Women who are pregnant or are breastfeeding. Female patients must be surgically sterile, be postmenopausal, or must agree to use effective contraception during the period of therapy. All female patients with reproductive potential must have a negative pregnancy test (serum or urine) prior to enrolment. Male patients must be surgically sterile or must agree to use effective contraception during the period of therapy.4. Current signs or symptoms of severe progressive or uncontrolled hepatic, endocrine, pulmonary disease other than directly related to RCC5. Gastrointestinal abnormalities including:5.1. Inability to take oral medication5.2. Requirement for intravenous alimentation5.3. Prior surgical procedures affecting absorption including total gastric resection5.4. Treatment for active peptic ulcer disease in the past 6 months5.5. Active gastrointestinal bleeding, unrelated to cancer, as evidenced by hematemesis, hematochezia or melena in the past 3 months without evidence of resolution documented by endoscopy or colonoscopy5.6. Malabsorption syndromes6. Current use or anticipated need for treatment with drugs that are known potent CYP3A4 inhibitors (see section 8.12, concomitant therapy)7. Current use or anticipated need for treatment with drugs that are known CYP3A4 or CYP1A2 inducers (see section 8.12, concomitant therapy)8. Requirement of anticoagulant therapy with oral vitamin K antagonists. Low-dose anticoagulants for maintenance of patency of central venous access device or prevention of deep venous thrombosis is allowed. Therapeutic use of low molecular weight heparin is allowed.9. Active seizure disorder, spinal cord compression, or carcinomatous meningitis10. Any of the following within 12 months prior to study entry: 10.1 myocardial infarction10.2 uncontrolled angina10.3 coronary/peripheral artery bypass graft10.4 symptomatic congestive heart failure10.5 cerebrovascular accident or transient ischemic attack11. Uncontrolled hypertension (>160/100 mmHg despite optimised antihypertensive treatment)12. Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness13. ALT or AST ≥1.5 x upper limit of normal; Bilirubin ≥1.5 x upper limit of normal14. Serum creatinine ≥1.5 x upper limit of normal15. Neutrophil count <1.0 x 10(9)/l; platelet count <100 x 10(9)/l; Hb ≤90 g/l16. Known severe hepatic impairment (Child-Pugh class C)17. Known hypersensitivity to axitinib or any of its excipients. Specifically patients with hereditary galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption should not enter the study.
Previous exclusion criteria as of 23/04/2018:1. Metastatic patients with poor risk on the Memorial Sloan Kettering Cancer Centre (MSKCC) score and deemed suitable for cytoreductive nephrectomy at time of enrolment2. Presence of active second malignancy. Patients will be eligible if they have adequately treated basal cell carcinoma, squamous cell skin cancer, in situ cervical cancer, stable prostate cancer or if treated with curative intent for any other cancer with no evidence of disease for 2 years. 3. Women who are pregnant or are breastfeeding. Female patients must be surgically sterile, be postmenopausal, or must agree to use effective contraception during the period of therapy. All female patients with reproductive potential must have a negative pregnancy test (serum or urine) prior to enrolment. Male patients must be surgically sterile or must agree to use effective contraception during the period of therapy.4. Current signs or symptoms of severe progressive or uncontrolled hepatic, endocrine, pulmonary disease other than directly related to RCC5. Gastrointestinal abnormalities including:5.1. Inability to take oral medication5.2. Requirement for intravenous alimentation5.3. Prior surgical procedures affecting absorption including total gastric resection5.4. Treatment for active peptic ulcer disease in the past 6 months5.5. Active gastrointestinal bleeding, unrelated to cancer, as evidenced by hematemesis, hematochezia or melena in the past 3 months without evidence of resolution documented by endoscopy or colonoscopy5.6. Malabsorption syndromes6. Current use or anticipated need for treatment with drugs that are known potent CYP3A4 inhibitors (see section 8.12, concomitant therapy)7. Current use or anticipated need for treatment with drugs that are known CYP3A4 or CYP1A2 inducers (see section 8.12, concomitant therapy)8. Requirement of anticoagulant therapy with oral vitamin K antagonists. Low-dose anticoagulants for maintenance of patency of central venous access device or prevention of deep venous thrombosis is allowed. Therapeutic use of low molecular weight heparin is allowed.9. Active seizure disorder, spinal cord compression, or carcinomatous meningitis10. Any of the following within 12 months prior to study entry: 10.1 myocardial infarction10.2 uncontrolled angina10.3 coronary/peripheral artery bypass graft10.4 symptomatic congestive heart failure10.5 cerebrovascular accident or transient ischemic attack11. Uncontrolled hypertension (>160/100 mmHg despite optimised antihypertensive treatment)12. Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness13. ALT or AST ≥1.5 x upper limit of normal; Bilirubin ≥1.5 x upper limit of normal14. Serum creatinine ≥1.5 x upper limit of normal15. Neutrophil count <1.0 x 10(9)/l; platelet count <100 x 10(9)/l; Hb ≤90 g/l16. Known severe hepatic impairment (Child-Pugh class C)17. Known hypersensitivity to axitinib or any of its excipients. Specifically patients with hereditary galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption should not enter the study.
Previous exclusion criteria1. The presence of active second malignancy. Patients will be eligible if they have adequately treated basal cell carcinoma, squamous cell skin cancer, in situ cervical cancer, stable prostate cancer or if treated with curative intent for any other cancer with no evidence of disease for 2 years. 2. Women who are pregnant or are breastfeeding. Female patients must be surgically sterile, be postmenopausal, or must agree to use effective contraception during the period of therapy. All female patients with reproductive potential must have a negative pregnancy test (serum or urine) prior to enrollment.3. Male patients must be surgically sterile or must agree to use effective contraception during the period of therapy4. Current signs or symptoms of severe progressive or uncontrolled hepatic, endocrine, pulmonary disease other than directly related to RCC. 5. Gastrointestinal abnormalities including:5.1. Inability to take oral medication5.2. Requirement for intravenous alimentation5.3. Prior surgical procedures affecting absorption including total gastric resection5.4. Treatment for active peptic ulcer disease in the past 6 months5.5. Active gastrointestinal bleeding, unrelated to cancer, as evidenced by hematemesis, hematochezia or melena in the past 3 months without evidence of resolution documented by endoscopy or colonoscopy5.6. Malabsorption syndromes6. Current use or anticipated need for treatment with drugs that are known potent CYP3A4 inhibitors (see section 8.12, concomitant therapy)7. Current use or anticipated need for treatment with drugs that are known CYP3A4 or CYP1A2 inducers (see section 8.12, concomitant therapy)8. Requirement of anticoagulant therapy with oral vitamin K antagonists. Low-dose anticoagulants for maintenance of patency of central venous access device or prevention of deep venous thrombosis is allowed. Therapeutic use of low molecular weight heparin is allowed.9. Active seizure disorder, spinal cord compression, or carcinomatous meningitis10. Any of the following within 12 months prior to study entry: myocardial infarction, uncontrolled angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack11. Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
This information has not yet been provided by the study team. You'll have an opportunity to discuss any risks and benefits that may be associated with this study prior to consenting to taking part.
Mrs
Kathleen
Riddle
Dr
Grant
Stewart
The study is sponsored by Common Services Agency and funded by Pfizer UK.
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
You can print or share the study information with your GP/healthcare provider or contact the research team directly.
