Neo-adjuvant versus Adjuvant chemotherapy in Upper Tract Urothelial Carcinoma: A feasibility phase II randomized clinical trial (“URANUS”)
Upper tract urothelial cancer is a type of cancer that starts in the lining of the kidney or the tubes connecting the kidneys to the bladder. Treatment usually involves both surgery and chemotherapy medicines like gemcitabine. However, doctors are not certain whether it is best to give chemotherapy before the operation or after it. The URANUS trial aims to answer this question. Patients are placed into one of two groups by chance. One group receives chemotherapy before their operation, and the other receives it afterwards. Researchers want to see which group finds it easier to finish all three planned cycles of chemotherapy. They will also follow patients for up to three years to see how well the cancer is kept away. The findings will help doctors choose the most effective treatment schedule for future patients.
At a glance
What is this study about?
Upper tract urothelial cancer is an uncommon cancer affecting the urinary system. It grows in the lining of the kidney or in the ureters, which are the tubes that carry urine from the kidneys down to the bladder. The standard care usually involves removing the affected kidney and tube with surgery, combined with chemotherapy to kill any remaining cancer cells.
Chemotherapy can be given at two different times: before surgery (known as neoadjuvant therapy) or after surgery (known as adjuvant therapy). Both approaches have potential benefits. Giving chemotherapy first might shrink the tumour and make it easier to remove. On the other hand, operating first removes the main tumour right away, but recovering from surgery can sometimes leave patients too tired or unwell to finish their chemotherapy afterwards.
This clinical trial, called URANUS, is designed to find out which approach works best in practice. Doctors want to know whether patients are more likely to successfully finish three full courses of chemotherapy if they have it before or after their operation.
Over the course of the study, researchers will also track patients' health for up to three years. They will check how long people stay free from cancer and look at overall survival rates. This information will help doctors provide clearer guidelines and better care for people diagnosed with this condition in the future.
Key takeaways
- The trial compares chemotherapy given before surgery against chemotherapy given after surgery.
- It involves adults with cancer of the lining of the kidney or the tubes leading to the bladder.
- The main goal is to see which timing makes it easier for patients to complete three full cycles of chemotherapy.
- Participants will receive standard chemotherapy (gemcitabine) and surgery, with follow-up for up to three years.
- Joining is entirely voluntary, and you can withdraw at any point without your care being affected.
Who may be eligible?
This study is open to adults aged 18 and over who have been diagnosed with urothelial cancer in the upper urinary tract. Both men and women can take part.
To join, you must be planning to have surgery to remove the tumour and be well enough to safely receive chemotherapy. Your hospital team will carry out health checks to make sure your kidneys, heart, and general fitness are strong enough for treatment.
You may not be able to join if you have already had certain cancer treatments, if the cancer has spread widely to other parts of the body, or if you have other serious medical conditions that make chemotherapy unsafe. Your doctor can review your scans and test results to see if this study is suitable for you.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- I am aged 18 or older.
- I have been diagnosed with upper tract urothelial cancer (cancer in the kidney lining or ureter).
- My medical team has recommended surgery to treat my cancer.
- I am well enough to receive chemotherapy treatments.
- I have not had recent cancer treatments that would rule me out.
What does participation involve?
If you take part, you will be placed into one of two treatment groups by chance (randomly). One group has three cycles of chemotherapy before their operation. The other group has their operation first, followed by three cycles of chemotherapy once they have recovered. The chemotherapy medicine used is gemcitabine, which is given into a vein through a small drip. You will visit the hospital regularly for blood tests, physical checks, and treatment sessions. After finishing both surgery and chemotherapy, you will have routine follow-up appointments and scans over a period of three years so doctors can monitor your health and recovery.
Potential risks and benefits
Locations (4)
- —UnverifiedNorway
- —UnverifiedSpain
- —UnverifiedNetherlands
- —UnverifiedSweden
Common questions
What is the URANUS trial testing?
It tests whether it is better to give chemotherapy before surgery or after surgery for cancer in the upper urinary tract.
Can I choose when I receive my chemotherapy?
No. A computer randomly decides whether you receive chemotherapy before or after your operation to ensure the study results are fair and unbiased.
How is the chemotherapy given?
The chemotherapy drug, gemcitabine, is usually given as a liquid through a small tube into a vein (an intravenous drip) during hospital day visits.
What happens if the side effects become too strong?
Your medical team will monitor you closely. They can adjust your dose, pause your treatment, or stop it early if they feel it is best for your safety.
Will taking part cost me anything?
No. The treatment is provided as part of clinical care, though you may need to travel to the hospital more often for visits and tests.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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