Ongoing Clinical Trials for Ureteric Cancer
Currently, there are 2 ongoing clinical trials exploring new approaches for ureteric cancer treatment and surgical recovery. These studies are being conducted across several European countries including Austria, France, Germany, Italy, Spain, and Sweden. One trial focuses on improving pain management and recovery after robot-assisted surgery for upper urinary tract conditions, while the other investigates a novel light-activated therapy for low-grade upper tract urothelial cancer.
Clinical trial locations
- Austria
- France
- Germany
- Italy
- Spain
- Sweden
Study on Spinal Morphine, Intravenous Lidocaine, and Bupivacaine for Patients Undergoing Robot-Assisted Surgery for Kidney or Ureter Conditions
This trial is examining different pain management strategies to improve recovery after robot-assisted surgery involving the kidneys or ureters. The study is open to adult patients scheduled for planned robotic-assisted surgery on the upper urinary tract, including those with conditions affecting these areas. Participants must be able to provide both written and spoken informed consent after receiving information about the study.
Main inclusion criteria: The trial welcomes adult patients of any gender who are scheduled for elective robot-assisted surgery on the upper urinary tract. Participants must be able to understand the study information and provide informed consent.
Main exclusion criteria: Patients with kidney or ureter cancer or tumors, kidney stones, or renal reflux are not eligible for this particular study.
Trial focus: The main goal is to determine whether different pain management approaches can enhance recovery after surgery. Researchers will compare the effects of spinal morphine, intravenous lidocaine, and a combination of bupivacaine with adrenaline. Recovery quality will be measured using a patient-centered scale called Quality of Recovery 15, along with monitoring pain levels and overall well-being at various points after surgery.
Investigational drugs: The study uses three main medications: bupivacaine, a local anesthetic administered as part of spinal analgesia to numb specific areas; morphine, a strong pain reliever injected into the space around the spinal cord; and lidocaine, a local anesthetic given intravenously through a vein to help manage pain.
Study on the Safety and Effectiveness of Padeliporfin Therapy for Patients with Low-Grade Upper Tract Urothelial Cancer
This trial is investigating a novel treatment approach for low-grade upper tract urothelial cancer, which affects the lining of the urinary system in areas such as the kidney and ureter. The study is testing TOOKAD (padeliporfin), a special light-activated therapy designed to target and treat cancer cells while preserving kidney function.
Main inclusion criteria: The trial is open to male and female patients aged 18 or older who can understand and provide written consent. Eligible participants must have new or returning low-grade, non-invasive upper tract urothelial cancer confirmed by biopsy, with up to 2 confirmed sites of cancer. The largest tumor must be between 5 and 15 millimeters in size, located in the calyces, renal pelvis, or ureter of the same kidney. Participants must have a Karnofsky Performance Status of 50% or higher, which measures the ability to perform daily activities. Additionally, adequate organ function is required, including specific levels of white blood cells, platelets, hemoglobin, blood clotting factors, kidney function, and liver enzymes.
Main exclusion criteria: While specific exclusion criteria are not detailed in the source data, the inclusion criteria indicate that patients must have low-grade disease only, without high-grade cells found in urine tests.
Trial focus: The study aims to evaluate the safety and effectiveness of TOOKAD therapy in treating low-grade upper tract urothelial cancer. The treatment involves giving the medication through an intravenous infusion, then activating it with laser light to precisely target cancer cells. Researchers will monitor participants over time to assess how well the treatment works, checking for the absence of cancer in treated areas through procedures like endoscopy. The study will also evaluate whether the treatment helps preserve kidney function and will record any side effects experienced by participants.
Investigational drug: TOOKAD (padeliporfin) is used in a therapy called Vascular Targeted Photodynamic Therapy. This medication is activated by light to generate reactive oxygen species that damage blood vessels supplying the tumor, leading to cancer cell death while minimizing damage to surrounding healthy tissue.
Summary
These two clinical trials represent different approaches to managing conditions affecting the upper urinary tract, including ureteric cancer. One trial focuses on optimizing surgical recovery through improved pain management strategies, while the other explores an innovative light-activated therapy specifically designed for low-grade upper tract urothelial cancer.
The pain management study is currently being conducted in Sweden, while the TOOKAD therapy trial has a broader European presence across Austria, France, Germany, Italy, and Spain. The TOOKAD study is particularly notable as it investigates a targeted photodynamic therapy that aims to preserve kidney function while treating cancer, representing a potentially less invasive alternative to traditional surgical approaches for eligible patients with low-grade disease.
Both trials reflect ongoing efforts to improve outcomes for patients with upper urinary tract conditions, whether through enhanced recovery protocols or novel therapeutic approaches to cancer treatment.