AuthorisedTherapeutic exploratory (Phase II)Interventional

ORGAN SPARING FOR LOCALLY ADVANCED RECTAL CANCER AFTER NEOADJUVANT TREATMENT FOLLOWED BY ELECTROCHEMOTHERAPY - LARC_ DEEP_CANCERS

This research trial, called LARC_DEEP_CANCERS, is exploring a new treatment for a type of bowel cancer that has grown locally but not spread far. It's for patients who have already had initial treatment (like chemotherapy or radiotherapy). The study uses a medicine called bleomycin combined with electrochemotherapy, which involves delivering small electrical pulses to the tumour. The main goals are to check if this new approach is safe, practical to use, and if it can help more people achieve a complete response, meaning the cancer disappears entirely. If successful, this could reduce the need for major surgery, improving quality of life for patients.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

IRCCS Istituto Nazionale Tumori Fondazione Pascale

Enrolment target

Start

10 Jan 2025

colorectal cancer

What is this study about?

This clinical trial is looking at a new way to treat a specific type of bowel cancer. This cancer is called 'locally advanced rectal cancer,' which means it has grown into the wall of the bowel or into nearby tissues, but hasn't spread to other distant parts of the body.

The study involves a treatment called electrochemotherapy, using a drug called bleomycin. You might have heard of chemotherapy, which uses drugs to kill cancer cells. Bleomycin is one such drug. Electrochemotherapy is a method where a small electrical pulse is used to help the chemotherapy drug get into the cancer cells more effectively. This could mean the drug works better right where it's needed.

The main idea behind this trial is to see if this treatment could help patients avoid major surgery, which can have significant side effects and a long recovery time. By getting rid of the cancer more effectively with this new approach, doctors hope to preserve the bowel and improve patients' quality of life after treatment. This is an early-stage study (Phase II), meaning doctors are mainly checking how safe it is and how well it works before it can be offered more widely.

Key takeaways

This study evaluates a new treatment for locally advanced bowel cancer.
It combines a chemotherapy drug (bleomycin) with electrical pulses (electrochemotherapy).
The goal is to see if this can improve outcomes and potentially reduce the need for surgery.
It is an early-stage study checking safety and effectiveness.
You must be over 18 and have locally advanced rectal cancer that has had initial treatment.

Who may be eligible?

To be considered for this study, you need to be an adult, 18 years old or older. The study is open to both men and women.

You would have been diagnosed with bowel cancer that has grown locally but hasn't spread to other parts of your body, and you would have already received some initial treatment for it.

The research team will assess your overall health and specific cancer details to make sure this study is right for you and that you meet all the necessary requirements safely.

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.

Are you 18 years old or older?
Have you been diagnosed with bowel cancer that has grown locally but not spread far?
Have you already received some initial treatments for your bowel cancer?
Are you able to attend regular hospital appointments for treatment and follow-up?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll first have some tests to make sure the study is suitable for you. This might include scans and blood tests. Once enrolled, you will receive the study treatment, which involves the drug bleomycin and electrochemotherapy. This treatment will be given over a period, and the medical team will explain the exact schedule.

You will have regular check-ups with the study doctors and nurses, which will include examinations, blood tests, and scans to see how you are responding to the treatment and to monitor your health. After your treatment is complete, you will continue to have follow-up visits for a set period to track your long-term health and any effects of the treatment. The total duration of your involvement, including treatment and follow-up, will be fully explained by the study team.

Potential risks and benefits

Taking part in any clinical trial has potential benefits and risks. A potential benefit of this trial is that the new treatment might be more effective in clearing your cancer, potentially reducing the need for major surgery. However, as with all treatments, there could be side effects from the medication or the electrochemotherapy. The medical team will monitor you closely for any issues, and you'll be given full details of known side effects. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Italy

Common questions

What is 'locally advanced rectal cancer'?

It's a type of bowel cancer that has grown into the lining of the bowel or nearby tissues, but hasn't yet spread to distant parts of the body.

What is bleomycin?

Bleomycin is a medicine used in chemotherapy to kill cancer cells.

What is electrochemotherapy?

This is a method where a small electrical pulse is used to help chemotherapy drugs get into cancer cells more effectively, making the treatment work better in the tumour.

Will I have to have surgery if I join this trial?

The aim of this treatment is to see if it can help reduce or remove your cancer so that extensive surgery might not be needed. However, this isn't guaranteed, and the doctors will discuss your individual treatment plan.

Who is running this study?

The study is being run by medical researchers focusing on improving treatments for bowel cancer.