All studies
RecruitingPHASE3INTERVENTIONAL

Neoadjuvant Upper Tract Invasive Cancer Trial (NAUTICAL)

This study, called NAUTICAL, is for a rare cancer found in the lining of the kidney or a tube called the ureter. Currently, surgery followed by chemotherapy is the usual treatment. However, for a similar bladder cancer, giving chemotherapy before surgery has shown better results. This study wants to see if this 'pre-surgery' chemotherapy also helps people with this rare kidney/ureter cancer live longer. There haven't been many studies on this specific cancer, so this trial will be the first in Canada to explore this new treatment timing. A key part of the study is also to find out if enough patients are available to take part in trials for such a rare condition.

At a glance

Status
Recruiting
Phase
PHASE3
Sponsor
University Health Network, Toronto
Enrolment target
14
Start
08 Feb 2021
Estimated completion
01 Dec 2027

What is this study about?

This study, called NAUTICAL, is looking into a treatment approach for a rare cancer that affects the lining of your kidney or the ureter. The ureter is the tube that carries urine from your kidney to your bladder. Because this type of cancer is uncommon, there haven't been many studies to figure out the very best way to treat it.

At the moment, the usual treatment involves surgery to remove the cancer, followed by chemotherapy (medicine to kill cancer cells). However, for a similar type of cancer in the bladder, doctors have found that giving chemotherapy *before* surgery can lead to people living longer. This is because chemotherapy given before surgery can help shrink the main tumour and also target any cancer cells that might have started to spread but aren't yet visible on scans.

This study aims to see if giving chemotherapy before surgery could also benefit people with this rare kidney or ureter cancer. It's the first study in Canada to try this approach for this specific condition. A big part of this initial study is also to understand if it's practical to gather enough patients for research into such a rare cancer. If successful, it could pave the way for bigger studies in the future that could change how this cancer is treated.

Key takeaways

  • It's for a rare cancer in the kidney or ureter lining.
  • It tests chemotherapy before surgery, an approach used for bladder cancer.
  • The usual treatment is surgery first, then chemotherapy.
  • Participation helps us understand if this new timing of chemotherapy is better.
  • We also need to see if enough patients can join future trials for rare cancers.

Who may be eligible?

To be considered for this study, you would generally need to have been recently diagnosed with this specific type of cancer in your kidney or ureter, and it should be visible on scans like CT or MRI. You also need to be 18 years or older and generally in good health, meaning you can carry out your normal daily activities without much difficulty. Importantly, your medical team will need to confirm that you are healthy enough to undergo both surgery and the specific chemotherapy medicines used in the study.

There are also some important reasons why you might not be able to join. For example, if your cancer has already spread to distant parts of your body or to your lymph nodes, or if you have another type of cancer diagnosis within the last two years (bladder cancer with specific treatments might be an exception). You also wouldn't be able to participate if you have serious hearing problems, significant nerve damage (neuropathy) from other conditions, or if you have a single kidney that's not functioning well.

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.

  1. I have recently been diagnosed with cancer in the lining of my kidney or ureter.
  2. I am at least 18 years old.
  3. I am generally well enough to go about my daily life.
  4. My doctors say I am healthy enough for both surgery and chemotherapy.
  5. My cancer has not spread far in my body (no distant spread or major lymph node involvement).
Answer every question to see your result.

What does participation involve?

If you join this study, you would first have an assessment to determine if you are suitable for chemotherapy before surgery. You would then be randomly assigned to either receive chemotherapy before your surgery or to go straight to surgery as is the current standard. If your cancer is found to be more advanced after surgery, you might also receive chemotherapy afterwards, depending on what group you were assigned to initially. You'll have regular hospital visits for scans, blood tests, and to see your doctors to check how you're responding to treatment and to monitor for any side effects. The total duration of your participation would depend on your treatment plan and follow-up schedule, which your doctor will explain in detail.

Potential risks and benefits

Potential benefits of taking part could include receiving a newer treatment approach (chemotherapy before surgery) that might lead to better outcomes compared to standard care, or contributing valuable information to help others with this rare cancer in the future. However, there are also potential risks associated with chemotherapy, such as side effects like nausea, tiredness, or infections, and risks linked to surgery. Your doctors will discuss all potential side effects and risks with you before you decide to join. Remember, you can choose to leave the study at any time without affecting your medical care.

Locations (2)

  • The Ottawa Hospital
    Verified postcode
    Ottawa, Canada· Recruiting
  • University Health Network
    Verified postcode
    Toronto, Canada· Recruiting

Common questions

What kind of cancer is this study for?

This study is for a rare cancer in the lining of your kidney or the tube that drains it, called the ureter.

What is 'chemotherapy before surgery'?

It's giving cancer-fighting medicines (chemotherapy) to you before your operation to remove the cancer, rather than after.

Why are you doing this study?

We want to see if giving chemotherapy before surgery helps people with this rare cancer live longer, similar to what's seen in bladder cancer.

Will I definitely get the new treatment?

Not necessarily. You'll be randomly assigned to either get chemotherapy before surgery or to have surgery first, like flipping a coin.

Is this the first time this approach has been tried for this cancer?

Yes, this is the first study in Canada to look at chemotherapy before surgery for this specific type of kidney/ureter cancer.

How to find out more

Emily Hickey

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "Neoadjuvant Upper Tract Invasive Cancer Trial (NAUTICAL)…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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