Active not recruitingPHASE3INTERVENTIONAL

Safety of a Boost (CXB or EBRT) in Combination With Neoadjuvant Chemoradiotherapy for Early Rectal Adenocarcinoma

This study is for people with early rectal cancer. Researchers are comparing two different ways to give extra radiation (a 'boost') alongside standard treatment. One boost uses a common method called External Beam Radiation Therapy (EBRT), and the other uses a special type called Contact X-ray Brachytherapy (CXB). The main goal is to see if CXB helps more patients keep their rectum and anus, potentially avoiding major surgery or a permanent colostomy bag, compared to the standard EBRT boost. This could be especially helpful for older patients who might not be strong enough for big operations. The study aims to find out if CXB can increase the chance of saving these organs by 20% over 3 years.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Centre Antoine Lacassagne

Enrolment target

148

Start

24 Jun 2015

Estimated completion

01 Jun 2030

Rectal Neoplasms

What is this study about?

This study is looking into new ways to treat early-stage rectal cancer, specifically in people who have small to medium-sized tumours. Currently, many people with this type of cancer have a major operation to remove the part of the bowel that has cancer. Sometimes, this surgery can lead to having a permanent colostomy bag, which changes how you go to the toilet.

Before surgery, people often have a combination of chemotherapy and radiation treatment. This helps to shrink the tumour. This study is testing if adding an extra, focused dose of radiation – called a 'boost' – in two different ways can increase the chances of avoiding this major surgery and keeping the rectum and anus. One way uses a standard radiation method (EBRT), and the other uses a more targeted internal radiation called Contact X-ray Brachytherapy (CXB). The aim is to see if CXB is better at saving the organ without the disease coming back locally, hopefully helping more patients avoid life-changing surgery, especially those who might find a big operation too difficult.

The researchers are particularly interested in seeing if the special CXB boost can increase the chance of saving the rectum and anus by 20% compared to the standard boost. They will be watching patients for three years to see how effective each treatment is at preventing the cancer from returning in the treated area and if people can avoid a permanent colostomy. This research is important because it could offer a gentler treatment path for many patients.

Key takeaways

Tests two ways to give extra radiation for early rectal cancer.
Aims to help patients avoid major surgery and keep their rectum/anus.
Compares standard external radiation (EBRT) to special internal radiation (CXB).
Focuses on patients with specific sizes and locations of tumours.
Could offer a gentler treatment path for suitable patients.

Who may be eligible?

To be considered for this study, you would generally need to have a specific type of early-stage rectal cancer that hasn't spread to other parts of your body. Your tumour should also be relatively small – less than 5cm across and not covering more than half of the inside of your rectum. Importantly, the tumour must be positioned in a way that allows the special internal radiation treatment (CXB) to be given directly to it, typically meaning it's fairly close to the anal opening.

You also need to be at least 18 years old and generally healthy enough to go through the planned treatments. There are certain situations that would mean you couldn't join. For example, if your cancer is more advanced, or if it's already spread. You also wouldn't be able to participate if you've had radiation treatment to your pelvis before, or if you have other serious health conditions that would make the treatment unsafe. The study also cannot include pregnant or breastfeeding women, or those unable to give their clear consent.

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 you have early-stage rectal cancer that has not spread?
Is your tumour less than 5cm and not covering too much of the rectum?
Is your tumour accessible for internal radiation treatment?
Are you generally healthy enough for chemotherapy and radiation?
Are you at least 18 years old?

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 combination of chemotherapy and radiation therapy for your rectal cancer. Then, depending on which group you are randomly placed into, you would receive an extra ‘boost’ of radiation. This boost would either be a standard type (EBRT) given from outside your body, or a special internal type (CXB) where the radiation is delivered directly to the tumour area. You would have regular check-ups and medical tests throughout the treatment period and for three years afterwards to monitor how well the treatment is working and to check for any side effects. These follow-up appointments may involve various scans and examinations.

Potential risks and benefits

Participating in this study might offer you a chance to keep your rectum and anus, potentially avoiding major surgery or a permanent colostomy bag, especially if the special CXB boost proves more effective. However, like all medical treatments, there are potential risks and side effects associated with chemotherapy and radiation, which your doctor will explain in detail. These can vary depending on the type and dose of treatment. You will also need to attend regular appointments and tests. It's important to remember that you can decide to stop participating in the study at any time, for any reason, without it affecting your usual medical care.

Locations (18)

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

Clinique de la Sauvegarde
Verified postcode
Lyon, France
CHRU Besançon
Verified postcode
Besançon, France
Centre Jean Godinot
Verified postcode
Reims, France
Centre Léon Bérard
Verified postcode
Lyon, France
Institut Paoli Calmettes
Verified postcode
Marseille, France
Centre d'oncologie et de radiothérapie Mâcon
Verified postcode
Mâcon, France
Centre Antoine Lacassagne
Verified postcode
Nice, France
Hospices Civils de Lyon - Centre Hospitalier Lyon-Sud
Verified postcode
Pierre-Bénite, France
Institut de Cancérologie Lucien Neuwirth
Verified postcode
Saint-Priest-en-Jarez, France
Clinique Charcot
Verified postcode
Sainte-Foy-lès-Lyon, France
Hôpital de la Croix Rouge Française - Centre de Radiothérapie St Louis
Verified postcode
Toulon, France
Centre de radiothérapie Bayard
Verified postcode
Villeurbanne, France

Common questions

What is a 'boost' in this study?

A 'boost' is an extra, focused dose of radiation. It's given after the initial main treatment to try and shrink the tumour even more.

What is the difference between EBRT and CXB?

EBRT is standard radiation given from outside your body. CXB is a special type of radiation delivered directly to the tumour from inside, which can give a high dose more safely.

Will I have surgery if I join this study?

The goal of this study is to help more people avoid major surgery or a permanent colostomy, but whether you have surgery will depend on how your tumour responds to the treatment.

How long will I be followed in this study?

You will be followed up for three years after your treatment starts to check how well it worked and for any side effects.

Why is this study important?

It could find a better way to treat early rectal cancer that helps more patients save their rectum and anus, potentially avoiding life-changing surgery, especially for older patients.