RecruitingPHASE2, PHASE3INTERVENTIONAL

Study Evaluating the Tailored Management of Locally-advanced Rectal Carcinoma

This study is for people with advanced bowel cancer that hasn't spread far. Currently, everyone gets a standard treatment. This trial wants to see if we can tailor a plan based on how your cancer responds to a strong but short course of chemotherapy called FOLFIRINOX. Doctors will use special MRI scans to see early on if the tumour is shrinking a lot. If it is, you might go straight to surgery or have further treatment before surgery. This personalised approach aims to improve the chances of successful treatment and reduce side effects from treatments you might not need. It's about finding the best path for each person.

At a glance

Status

Recruiting

Phase

PHASE2, PHASE3

Sponsor

Institut du Cancer de Montpellier - Val d'Aurelle

Enrolment target

1,075

Start

26 Nov 2021

Estimated completion

01 Aug 2026

Locally Advanced Malignant Neoplasm Rectal Carcinoma

What is this study about?

When you have advanced bowel cancer that is still contained (doctors call this 'locally advanced rectal cancer'), doctors want to control the cancer and also ensure that the treatments don't cause too many problems or side effects. Current treatments like surgery, chemotherapy, and radiotherapy can help, but sometimes surgery alone isn't enough, and radiotherapy can cause side effects. We know that how well a cancer responds to treatment before surgery can tell us a lot about how aggressive it is.

At the moment, everyone with this type of cancer gets a similar treatment plan. However, some people respond really well to the first course of chemotherapy, while others don't respond as much. Giving everyone the same treatment means that those who respond well might get extra treatments they don't truly need, leading to unnecessary side effects. On the other hand, those who don't respond well might not get the most effective treatment for their situation.

This study's main goal is to make treatment more personal. It involves giving a strong, but short, course of chemotherapy first. Then, doctors will use special MRI scans to check very early on how much the tumour has shrunk. This helps them work out if you are a 'good responder' or not. Depending on this early response, your treatment path will be adjusted. For example, if you respond really well, you might go straight to surgery, or have a combination of radiotherapy and surgery, aiming to improve your chances of recovery while hopefully reducing the overall side effects. It's all about finding the most effective and least harmful treatment for you.

Key takeaways

This study aims to personalise bowel cancer treatment.
Initial chemotherapy response guides further treatment decisions.
MRI scans are used to check early tumour shrinkage.
It could potentially reduce side effects of unnecessary treatments.
The goal is better outcomes tailored to individual patients.

Who may be eligible?

To be considered for this study, you need to be an adult over 18 and have locally advanced bowel cancer that has been confirmed by a doctor, specifically in the rectum. Your general health should be good enough to take part in a study like this. Importantly, your cancer should not have spread to other parts of your body that can be seen on scans, and the tumour needs to be a certain size or type as shown on an MRI scan.

There are also some reasons why you might not be able to join. For example, if your tumour is very small and can't be easily measured by MRI, or if it's located extremely low in the rectum, you might not be suitable. Also, if you have certain heart conditions, a history of other specific cancers within the last five years (except for some very minor types), or have recently experienced blood clots, you might not be able to participate for your safety.

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 bowel cancer in your rectum that hasn't spread to distant sites?
Has your doctor confirmed your cancer type as 'adenocarcinoma'?
Are your CT and MRI scans being evaluated for the specific tumour characteristics the study needs?
Do you have good general health (e.g., no severe heart issues or recent blood clots)?

Answer every question to see your result.

What does participation involve?

If you take part in this study, you will first receive a short and intensive course of chemotherapy. During this time, you will have regular check-ups and MRI scans to see how your tumour is responding. Based on these early MRI results, your doctors will then assign you to one of two groups: either you'll have surgery straight away, or you'll have radiotherapy followed by surgery. The total length of your participation will depend on which treatment path you are on, including follow-up appointments after surgery. Your study doctor will be able to give you a more precise timeline.

Potential risks and benefits

Taking part in a study like this could offer the benefit of a more personalised treatment plan, potentially leading to better outcomes or fewer unnecessary side effects compared to standard treatment. However, all medical treatments carry risks. The chemotherapy and radiotherapy used can have side effects, and surgery has its own risks. The research team will carefully monitor you for any problems. Remember, joining this study is completely voluntary, and you are free to withdraw at any time without affecting your usual medical care.

Locations (30)

Institut Paoli Calmettes
Verified postcode
Marseille, France· Recruiting
Hôpital Nord de Marseille
Verified postcode
Marseille, France· Not yet recruiting
Hôpital Européen de MARSEILLE
Verified postcode
Marseille, France· Recruiting
CHU Besançon
Verified postcode
Besançon, France· Recruiting
CHU de Bordeaux
Verified postcode
Bordeaux, France· Recruiting
Insitut Régional du Cancer de Montpellier
Verified postcode
Montpellier, France· Recruiting
CHU de Nancy
Verified postcode
Vandœuvre-lès-Nancy, France· Recruiting
Centre Alexis Vautrin
Verified postcode
Nancy, France· Recruiting
Centre Oscart Lambret
Verified postcode
Lille, France· Recruiting
CHU Amiens
Verified postcode
Amiens, France· Recruiting
CHU Clermont-Ferrand
Verified postcode
Clermont-Ferrand, France· Recruiting
CH PAU
Verified postcode
Pau, France· Recruiting

Common questions

What is 'locally advanced rectal carcinoma'?

This means you have bowel cancer in your rectum (the last part of your large bowel) that has grown into nearby tissues but hasn't spread to distant parts of your body.

What is FOLFIRINOX chemotherapy?

This is a type of strong chemotherapy given as a mix of several different drugs. It's often used for certain advanced cancers to help shrink tumours.

What is 'MRI volumetry'?

This is a special way of using MRI scans to accurately measure the size and volume of your tumour. It helps doctors see how much it has shrunk after treatment.

What does being a 'good responder' mean?

It means your cancer has shrunk significantly after the initial chemotherapy, showing it responded well to that treatment.

Will I definitely avoid radiotherapy if I'm a 'good responder'?

Not necessarily. If you're a 'very good' responder, you might be randomly chosen to either have surgery straight away or have radiotherapy followed by surgery, to see which approach works best.

How to find out more

Philippe Rouanet, MD

philippe.rouanet@icm.unicancer.fr 4 67 61 30 71 Official trial record

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