RecruitingPHASE3INTERVENTIONAL

Neoadjuvant Chemotherapy for Obstructive Colon cancER First Treated by cOlostomy

This study is for people diagnosed with colon cancer that has caused a blockage in their bowel. Currently, these patients often have a temporary colostomy (a procedure to divert waste) followed by surgery. This research is investigating a new approach: giving chemotherapy before the main surgery. The idea is that this "pre-surgery" chemotherapy (doctors call this neoadjuvant chemotherapy) might help in a few ways. It could shrink the tumour, making it easier to remove completely. It might also target any tiny cancer cells that have spread but aren't yet detectable, potentially improving the chances of a full recovery. Researchers want to see if this new strategy leads to more patients receiving all the necessary treatment, both before and after surgery, which could improve their long-term health.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

University Hospital, Rouen

Enrolment target

232

Start

07 May 2024

Estimated completion

01 Aug 2031

Colon Cancer

What is this study about?

When someone has colon cancer that causes a blockage in the bowel, doctors usually need to act quickly to relieve the blockage. This often involves a procedure called a colostomy, where a bag is used to collect waste, followed by surgery to remove the cancer. However, treatment for colon cancer often includes chemotherapy, which can be given after surgery to help prevent the cancer from coming back.

This study is exploring a different approach for these specific patients. Instead of just surgery after the colostomy, the researchers want to see if giving chemotherapy first, before the main cancer removal surgery, could be more helpful. This early chemotherapy is called "neoadjuvant chemotherapy." The hope is that this treatment might shrink the tumour, making the surgery to remove it more successful and complete. It could also target any tiny cancer cells that might have started to spread but are too small to be seen, potentially improving the patient's overall outcome.

The main goal is to find out if this approach helps more patients get the most complete treatment possible, including both pre-surgery and possibly post-surgery chemotherapy. This combination could lead to better results for people with colon cancer that has caused a blockage, by not only removing the visible tumour but also tackling any hidden cancer cells that could cause problems later on.

Key takeaways

This study explores giving chemotherapy before surgery for colon cancer causing a blockage.
The goal is improved treatment and potential long-term benefits.
It aims to shrink the tumour and target unseen cancer cells.
Eligibility depends on specific cancer type, health, and no prior chemotherapy.
You can stop participating at any time.
Your regular care will continue even if you don't join.

Who may be eligible?

To join this study, you would need to be at least 18 years old and generally well enough to manage daily activities without major difficulty. You must have colon cancer that has caused a blockage and has been treated with a temporary colostomy. The cancer should be confirmed as a specific type (adenocarcinoma) and not have spread to other parts of your body like the lungs or liver.

There are also some important health checks you'd need to pass, including blood tests to make sure your organs are working well enough for chemotherapy. You shouldn't have had any chemotherapy or radiotherapy for cancer before, and you shouldn't have a history of other serious health problems that might make treatment risky. Women who could become pregnant would need to use effective contraception during the study and for some time afterwards.

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?
Do you have colon cancer that's caused a bowel blockage, for which you've had a temporary colostomy?
Has your cancer not spread to other parts of your body?
Have you *not* had chemotherapy or radiotherapy for this cancer before?
Are you generally well enough for everyday activities?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first have a temporary colostomy to relieve your bowel blockage, if you haven't already had one. Then, instead of going straight to surgery for the cancer, you would receive chemotherapy before the main operation to remove the tumour. After your main surgery, doctors would assess your tumour to decide if further chemotherapy treatment is needed.

Throughout the study, you would have regular hospital visits for blood tests, check-ups, and scans to monitor your health and how the treatment is working. This will include keeping track of any side effects you might experience. The total duration of your participation would depend on your individual treatment plan, including the pre-surgery chemotherapy, the surgery itself, and any follow-up chemotherapy, as well as regular check-ups afterwards.

Potential risks and benefits

Taking part in any clinical study has potential benefits and risks. A potential benefit of this study is that the pre-surgery chemotherapy might shrink your tumour, making your surgery more successful, and could also target any hidden cancer cells, potentially improving your long-term health. However, chemotherapy can cause side effects like feeling sick, tiredness, or hair loss, and there's a risk of complications from both the chemotherapy and the surgery. While we aim to make treatments as safe as possible, not everyone will experience a benefit. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (28)

Chu Amiens
Verified postcode
Amiens, France· Recruiting
Chr Beauvais
Verified postcode
Beauvais, France· Recruiting
Chru Besancon
Verified postcode
Besançon, France· Recruiting
Aphp Avicenne
Verified postcode
Bobigny, France· Recruiting
CHU CAEN
Verified postcode
Caen, France· Recruiting
Aphp Antoine Beclere
Verified postcode
Clamart, France· Recruiting
Chu Colmar
Verified postcode
Colmar, France· Recruiting
Chu Dijon
Verified postcode
Dijon, France· Recruiting
Chu Grenoble
Verified postcode
Grenoble, France· Recruiting
Aphp Kremlin Bicetre
Verified postcode
Le Kremlin-Bicêtre, France· Recruiting
Chru Lille
Verified postcode
Lille, France· Recruiting
Chru Lille
Verified postcode
Lille, France· Recruiting

Common questions

What is 'neoadjuvant chemotherapy'?

It's chemotherapy given before a main surgery or treatment, with the aim of shrinking a tumour or killing cancer cells early.

What is a 'colostomy'?

A colostomy is an operation to create an opening in your tummy, where a part of your bowel is brought to the surface. A bag is worn over the opening to collect waste, helping to relieve a bowel blockage.

What does 'non-metastatic colon cancer' mean?

This means your colon cancer has not spread from your bowel to other parts of your body, like your lungs or liver.

Will I still get standard care if I don't join the study?

Yes, your medical team will continue to provide the best standard care for your condition, regardless of whether you participate in the study.

How long will I be in the study?

The total time you spend in the study will vary, as it includes chemotherapy before surgery, the surgery itself, and any follow-up chemotherapy or check-ups. Your care team can give you a more precise timeline.

How to find out more

Valérie Bridoux

valerie.bridoux@chu-rouen.fr 0232881347 Official trial record

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