AuthorisedTherapeutic confirmatory (Phase III)Interventional

Efficacy of the use of neoadjuvant with/without hyperthermic intraperitoneal chemotherapy in the treatment of locally advanced colon cancer: A phase III multi-arm, randomized and controlled clinical trial (FOXHIPECT4)

This research study, called FOXHIPECT4, is for people with advanced colon or upper rectal cancer that hasn't spread far. It's comparing standard surgery and chemotherapy to a new approach that also includes a heated chemotherapy wash inside the tummy during surgery. This heated wash, called HIPEC, aims to kill any tiny cancer cells that might be left behind. The main goal is to see if adding HIPEC helps people stay cancer-free for longer and improves their chances of survival. Researchers will also look at how safe these treatments are and what side effects might occur. This is a Phase III study, meaning it's comparing a new treatment to the best current treatment to see which is better.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Fundacion Para La Investigacion Biomedica De Cordoba

Enrolment target

1,083

Start

05 Aug 2025

What is this study about?

This important study, named FOXHIPECT4, is looking for better ways to treat a type of bowel cancer that has grown a bit deeper into the bowel wall or nearby tissues, but hasn't spread to other distant parts of the body. This is often called locally advanced colon or upper rectal cancer. Doctors currently treat this with surgery, usually followed by chemotherapy. This study is testing if adding a special treatment called HIPEC during surgery can further improve outcomes.

HIPEC stands for Hyperthermic Intraperitoneal Chemotherapy. During your surgery, once the main tumour has been removed, a heated chemotherapy liquid is circulated inside your tummy for a short time. The idea is that this heated liquid can reach and kill any very small cancer cells that might be left behind in the tummy, which might not be seen otherwise. By doing this, doctors hope to reduce the chance of the cancer coming back and help people live longer.

This is a Phase III study, which means it's a large and important trial. People taking part will be randomly assigned to either receive the standard treatment or the standard treatment plus HIPEC. This allows doctors to fairly compare the two approaches to find out which one is more effective and safer. The main thing they want to find out is whether adding HIPEC helps people live longer without their cancer returning. They will also be carefully checking for any side effects and how people feel during and after treatment.

Key takeaways

This study is for locally advanced colon or upper rectal cancer.
It compares standard treatment to standard treatment plus heated chemotherapy (HIPEC) during surgery.
The main goal is to see if HIPEC helps people stay cancer-free longer.
It's a large Phase III study, aiming to find the best possible treatment.
Participation involves close monitoring over several years.

Who may be eligible?

This study is designed for adults of any age (18 or older) who have been diagnosed with a specific type of locally advanced colon or upper rectal cancer. This particular cancer must not have spread to distant parts of the body.

Doctors will confirm your cancer type and stage using scans like CT or MRI. They are specifically looking for cancers that are in a certain stage of growth (known as cT4N0-2M0), which means the cancer has grown into deeper layers or nearby lymph nodes, but not elsewhere. Sometimes, if the cancer has grown a little way into the fat around the bowel (more than 5mm), you might also be considered.

The study is open to both men and women. Your medical team will carefully review all your test results and health information to determine if this study is suitable for you.

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 locally advanced colon or upper rectal cancer?
Has your doctor confirmed your cancer hasn't spread to distant parts of your body?
Are you able to undergo surgery and chemotherapy?
Has imaging (like CT or MRI) shown your cancer at a specific stage (cT4N0-2M0)?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be randomly assigned to one of the treatment groups – either standard surgery with chemotherapy, or standard surgery with chemotherapy plus the HIPEC procedure. This decision is made by chance, like flipping a coin, to make sure the results are fair.

You will undergo your planned surgery. If you are in the HIPEC group, the heated chemotherapy will be given inside your tummy during this operation. After surgery, you will receive chemotherapy medicines, which might include combinations like FOLINIC ACID, MITOMYCIN, FLUOROURACIL, OXALIPLATIN, or CAPECITABINE. The specific combination will be decided by your medical team based on what is best for your cancer.

Throughout the study, you will have regular check-ups, scans, and blood tests to monitor your health, how well the treatment is working, and to check for any side effects. These follow-up appointments will continue for several years to track your long-term health and if the cancer stays away. The exact number and frequency of visits will be explained by the study team, but generally, you can expect close monitoring for at least three years, and likely longer.

Potential risks and benefits

Taking part in a clinical trial offers potential benefits, such as receiving a new and potentially more effective treatment for your cancer, or receiving very close medical monitoring and care. However, there are also potential risks, including side effects from the treatments. Chemotherapy can cause various side effects, and the HIPEC procedure may add its own unique risks, such as increased surgical complications. The research team will explain all known potential risks in detail so you can make an informed decision. Remember, your participation is voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your future 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
Spain

Common questions

What is 'locally advanced' colon cancer?

It means the cancer has grown into deeper layers of your bowel or nearby tissues, but hasn't spread to other distant parts of your body yet.

What is HIPEC?

HIPEC is Hyperthermic Intraperitoneal Chemotherapy, a heated chemotherapy wash given inside your tummy during surgery to kill any tiny remaining cancer cells.

Why is it called a 'Phase III' study?

Phase III means it's a large study comparing a new treatment (HIPEC plus standard care) against the best current standard treatment to see which is better.

What are the main things doctors want to find out?

Mainly, they want to see if adding HIPEC helps people live longer without their cancer coming back, and if it improves their overall survival.

Will I get to choose my treatment group?

No, you will be randomly assigned to either the standard treatment group or the group receiving standard treatment plus HIPEC. This is done to ensure the study results are fair and unbiased.