RecruitingPHASE1INTERVENTIONAL

In Vivo Lung Perfusion for Pulmonary Metastases of Sarcoma

This study is looking for a better way to treat sarcoma cancer that has spread to the lungs. Currently, surgery is common, but the cancer often returns because tiny cells remain. Standard chemotherapy after surgery isn't usually recommended due to side effects and limited proven benefits. This trial investigates a new technique called In Vivo Lung Perfusion (IVLP). During surgery, chemotherapy is delivered directly into one lung to target any remaining microscopic cancer cells. This aims to protect other parts of the body from harmful side effects. The study will first check how safe this method is and how well it works, in the hope that it could lead to better treatments for patients in the future.

At a glance

Status

Recruiting

Phase

PHASE1

Sponsor

University Health Network, Toronto

Enrolment target

Start

01 Feb 2016

Estimated completion

01 Sep 2030

Bone Sarcoma Soft Tissue Sarcoma Pulmonary Metastases

What is this study about?

When sarcoma cancer spreads from its original site to the lungs, it's called pulmonary metastases. While surgery to remove these growths is often used, many patients find the cancer comes back. This is because there might be tiny cancer cells in the lungs that are too small to see or remove during surgery. Unfortunately, giving chemotherapy throughout the body after surgery for this type of cancer hasn't been shown to help much and can cause unpleasant side effects.

This study is testing a completely new approach called In Vivo Lung Perfusion (IVLP). The idea is to deliver powerful anti-cancer medicines directly into the lung during surgery. By isolating the lung for a short period, the chemotherapy can reach these small cancer cells directly, hopefully killing them off. This method is designed to keep the medicine from travelling around the rest of the body, which could reduce the side effects that patients commonly experience with regular chemotherapy.

Since this is a new technique, the main goal of this first-phase study is to make sure it's safe for patients. We also want to see if it shows any promise in treating the cancer. For patients who have cancer in both lungs, one lung will receive this new IVLP treatment, while the other will be treated with standard care, such as further surgery or radiotherapy. This allows doctors to compare the new treatment with existing methods. We will carefully watch patients for up to two years to understand both the safety and any potential benefits.

Key takeaways

This study is for people with sarcoma that has spread to both lungs.
It's testing a new way to deliver chemotherapy directly into one lung during surgery.
The main aim is to check if this new treatment is safe and shows early promise.
It could potentially lead to fewer body-wide side effects compared to traditional chemotherapy.
Participants will be closely monitored for up to two years after the surgery.

Who may be eligible?

To join this study, you need to have a specific type of cancer called soft tissue or osteogenic (bone) sarcoma that has spread to both lungs. You must have at least three cancer spots in total in your lungs, and you can't have any cancer detected outside of your lungs. You also need to be under 65 years old (but at least 18) and generally well enough to undergo surgery, as judged by your doctor.

There are also some important things that would prevent you from joining. For example, if you've had too much of a specific chemotherapy medicine called doxorubicin in the past, or if you have serious heart or lung problems. If you are pregnant or breastfeeding, or if you've already had surgery to remove lung cancer in the past, you wouldn't be able to participate. Also, you cannot be part of another treatment study at the same time, or be allergic to doxorubicin.

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.

Do I have sarcoma that has spread to both of my lungs?
Am I between 18 and 64 years old?
Is my cancer only in my lungs, and not elsewhere in my body?
Am I generally well enough to have surgery?
Have I not had too much of the chemotherapy drug doxorubicin before?
Am I not pregnant or breastfeeding?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you will have surgery. During this surgery, doctors will temporarily cut off the blood supply to one of your lungs. They will then deliver a chemotherapy medicine directly into that lung for about three hours. After this, any visible cancer growths in that lung will be removed. The other lung, which has cancer too, will be treated separately either with surgery or radiation. You will stay in the hospital as you would for any major surgery, receiving all the usual care. After you leave the hospital, doctors will check on your health and progress for up to two years to see how you are doing.

Potential risks and benefits

The main potential benefit of this study is that this new technique might be more effective at treating cancer in the lungs than current methods, by targeting cancer cells more directly and potentially reducing side effects on the rest of your body. However, as with any new medical treatment, there are potential risks, including side effects from the chemotherapy and the surgical procedure itself. We are carefully checking for these risks as part of this first-phase study. Remember, your participation is voluntary, and you have the right to withdraw from the study at any time without affecting your future medical care.

Locations (1)

Princess Margaret Cancer Centre
Verified postcode
Toronto, Canada· Recruiting

Common questions

What is sarcoma?

Sarcoma is a rare type of cancer that grows in the connective tissues of the body, like bones, muscles, fat, nerves, blood vessels, and cartilage.

What does 'pulmonary metastases' mean?

This means that the sarcoma cancer has spread from where it started to your lungs. 'Pulmonary' refers to the lungs, and 'metastases' means the cancer has spread.

What is a 'Phase 1' study?

A Phase 1 study is the first stage of testing a new treatment in humans. Its main goal is to find out if the treatment is safe and to determine the best dose to use, rather than how effective it is.

Will I receive a placebo?

No, you will not receive a placebo. In this study, one of your lungs will receive the new chemotherapy treatment during surgery, and the other lung will be treated using standard care methods (like surgery or radiation).

Why is it important that the cancer hasn't spread outside the lungs?

This study specifically focuses on treating cancer within the lungs. If the cancer has spread to other parts of the body, this particular treatment method would not be suitable or effective for those areas.

How to find out more

Marcelo Cypel, M.D.

marcelo.cypel@uhn.ca 416-581-7773 Official trial record

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