Clinical trial · Interventional
Sorafenib in Treating Patients With Locally Advanced or Metastatic Kidney Cancer
Correlation of Pathologic Findings After Neo-adjuvant Sorafenib With Results of Diffusion-Weighted Magnetic Resonance Imaging in Patients With Locally Advanced or Metastatic Clear Cell Renal Cell Carcinoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Low Accrual
Summary
Brief summary (as posted)
RATIONALE: Sorafenib 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 sorafenib before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. PURPOSE: This clinical trial is studying how well sorafenib works in treating patients with locally advanced or metastatic kidney cancer.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hereditary Clear Cell Renal Cell Carcinoma | Hereditary Clear Cell Renal Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Kidney Cancer | Malignant Kidney Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sorafenib | Drug | Sorafenib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Sorafenib
- description
- Eligible patients undergo pre-treatment DW-MRI of the abdomen and pelvis. Patient then receive Sorafenib 400mg orally twice daily on days 1-28. Following completion of 28 days of sorafenib, patients obtain a second DW-MRI.
- interventionNames
- Drug: Sorafenib
Primary outcomes (2)
- measure
- Percentage Change in Difference in Apparent Diffusion Coefficient Between Baseline and Week 5
- timeFrame
- Baseline and week 5
- description
- Mean Difference in Apparent Diffusion Coefficient \[Time Frame: Baseline and Week 5\] To assess whether changes in the apparent diffusion coefficient (ADC) during neoadjuvant sorafenib treatment are detectable in locally advanced or metastatic kidney cancer. The ADC value will be calculated at baseline (within 28 days of initiating sorafenib) and Week 5, and the mean difference will be calculated. The percent change between this mean difference is reported. Week 5 ADC value minus baseline ADC value/divided by baseline ADC value was calculated for each participant. Apparent diffusion coefficient (ADC), obtained by measuring diffusion values at magnetic resonance imaging (MRI), is a measure of water mobility. Lower values correspond to tumor and higher values are consistent with cysts. With sorafenib therapy, the amount of free water may increase in a lesion due to necrosis, and as a result the ADC may increase in value.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed newly diagnosed clear cell renal cell carcinoma, meeting 1 of the following criteria: * Localized disease, as evidenced by intact, bulky, and primary renal lesions (T1 \> 3 cm, any T2, T3, or T4) appropriate for nephrectomy * Limited metastatic disease, as evidenced by any renal primary (T1 \> 3 cm, any T2, T3, or T4) appropriate for cytoreductive nephrectomy * Isolated abdominal/pelvic recurrence with limited metastatic burden (minimum size \> 2 cm) appropriate for metastasectomy * No known brain metastasis * Patients with neurological symptoms must undergo a CT scan/MRI of the brain to exclude brain metastasis PATIENT CHARACTERISTICS: * Eastern Cooperative Oncology Group performance status 0-1 * Hemoglobin ≥ 9.0 g/dL * Absolute neutrophil count ≥ 1,500/mm³ * Platelet count ≥ 100,000/mm³ * Total bilirubin ≤ 1.5 times upper limit of normal (ULN) * Alanine aminotransferase and Aspartate aminotransferase ≤ 2.5 times ULN (≤ 5 times ULN with liver involvement) * Creatinine ≤ 1.5 times ULN * Estimated glomerular filtration rate \> 30 mL/min (for patients receiving Gd-enhanced MRI) * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception prior to, during (men and women), and for at least 3 months after (men) completion of study therapy * Adequate cardiac and pulmonary status for operative therapy * No active clinically serious infection \> CTCAE grade 2 * No known HIV, hepatitis B, or hepatitis C infections * No serious non-healing wound, ulcer, or bone fracture * No significant traumatic injury within the past 4 weeks * No pulmonary hemorrhage/bleeding event ≥ CTCAE grade 2 within the past 4 weeks * No other hemorrhage/bleeding event ≥ CTCAE grade 3 within the past 4 weeks * No history of an uncontrolled bleeding disorder including, but not limited to, any of the following: * Bleeding diathesis * Coagulopathy * No cardiac disease or condition including, but not limited to, any of the following: * New York Heart Association class II-IV congestive heart failure * Unstable angina (anginal symptoms at rest) * New onset angina beginning within the last 3 months * Myocardial infarction within the past 6 months * Cardiac ventricular arrhythmias requiring antiarrhythmic therapy * No uncontrolled hypertension (i.e., systolic blood pressure \[BP\] \> 150 mm Hg or diastolic BP \> 100 mm Hg) despite optimal medical management * No thrombolic or embolic events within the past 6 months (e.g., cerebrovascular accident including transient ischemic attacks) * No condition that impairs the ability to swallow whole pills * No malabsorption problem * No contraindication to MRI, including, but not limited to, any of the following: * Ferromagnetic implants * Dental work * Pacemakers * Metallic implants * Severe claustrophobia which precludes closed MRI testing * No known or suspected allergy to sorafenib tosylate * No contraindication or allergy to gadolinium (e.g., end stage renal disease requiring hemodialysis) * No intercurrent illness or situation which, in the judgment of the investigator, would affect assessments of clinical status and study endpoints significantly PRIOR CONCURRENT THERAPY: * See Disease Characteristics * More than 4 weeks since prior major surgery or open biopsy * No prior therapy with tyrosine kinase or vascular endothelial growth factor inhibitors (e.g., sunitinib malate, sorafenib, or bevacizumab) * No concurrent Hypericum perforatum (St. John's wort) or rifampin * No concurrent use of illicit drugs or other substances that may, in the opinion of the investigator, have a reasonable chance of contributing to toxicity or interfering with study results
References
Publications (0)
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