RecruitingPHASE3INTERVENTIONAL

Preoperative FOLFOX Versus Postoperative Risk-adapted Chemotherapy in Patients With Locally Advanced Rectal Cancer

This research study is for people with locally advanced rectal cancer, specifically those with a lower risk of the cancer returning in the treated area. It's designed to compare two main treatment schedules: giving strengthening chemotherapy before surgery (called neoadjuvant therapy) or giving it after surgery based on how advanced the cancer turns out to be (risk-adapted adjuvant therapy). The main goal is to find the most effective way to prevent the cancer from spreading to other parts of the body, which is a common concern even after successful removal of the main tumour. By making sure patients receive effective treatment early, the study hopes to improve overall outcomes for patients with this specific type of rectal cancer.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Ralf Hofheinz

Enrolment target

550

Start

30 Sep 2020

Estimated completion

01 Aug 2030

Rectal Cancer

What is this study about?

This study is looking into the best way to treat a type of bowel cancer called rectal cancer, specifically when it's considered 'locally advanced'. This means the cancer has grown into nearby tissues but hasn't yet spread to distant parts of the body. Usually, patients with this type of cancer have chemotherapy and radiotherapy before surgery, followed by surgery to remove the tumour.

However, some patients have a lower risk of the cancer coming back in the treated area. For these individuals, the study wants to explore whether a different approach is more effective at stopping the cancer from spreading to other parts of the body. Currently, even with good treatment, there's still a chance (about 20-25%) that the cancer could return elsewhere. This study aims to reduce that risk by trying a new treatment plan.

Researchers are comparing two main approaches. One group of patients will receive chemotherapy for three months *before* their surgery. The other group will have surgery first, and then their doctors will decide on chemotherapy *after* surgery, depending on what the doctors find about the cancer's stage. The hope is that giving chemotherapy earlier can be more effective in preventing the cancer from spreading and can help more patients receive all the chemotherapy they need.

Key takeaways

This study compares chemotherapy before surgery versus after surgery for a specific type of rectal cancer.
It's for patients with locally advanced rectal cancer who have a lower risk of the cancer returning in the original area.
The main goal is to find a better way to stop the cancer from spreading to other parts of the body.
Careful MRI scans are used to select patients who might benefit most from this treatment approach.
Participants will be randomly assigned to one of two treatment groups.

Who may be eligible?

To join this study, you would typically be an adult (18 or older) with rectal cancer that has been diagnosed as 'locally advanced'. This means the cancer has grown a bit, but hasn't spread to other parts of your body, which will be checked with scans like MRI and CT.

The location and specific characteristics of your tumour will be carefully checked using detailed MRI scans. For example, if your tumour is in the lower or middle part of your rectum, it needs to meet certain size and spread criteria. If it's in the upper part, the rules might be a bit different. The doctors will also check your general health to make sure you're well enough for the treatments, looking at things like your blood counts and how well your liver and kidneys are working.

You wouldn't be able to join if your cancer has already spread to distant parts of your body, or if you've already had cancer treatment for your rectal cancer. The study needs to make sure all participants are in a similar situation to get clear results.

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 rectal cancer?
Have your recent scans (MRI of the pelvis, CT of chest/abdomen) shown no cancer spread to distant organs?
Have you not had any prior treatment for your rectal cancer?
Are you generally well and able to manage daily activities without much difficulty?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be assigned by chance to one of two treatment groups. In one group, you'll receive a type of chemotherapy called FOLFOX or XELOX for three months, *before* you have surgery to remove the tumour. In the other group, you'll have your surgery first, and then your doctors will decide on any chemotherapy needed *after* surgery based on the cancer's stage.

Throughout the study, you'll have regular hospital visits for medical check-ups, blood tests, and scans (like MRI and CT) to monitor your health and how the treatment is working. The specific timing and number of visits will depend on which treatment group you are in and will be explained in detail by the study team. You'll also have follow-up appointments after your main treatment is complete to keep an eye on your progress over time. The total duration of your active participation, including follow-up, will be outlined by the study team.

Potential risks and benefits

Taking part in this study could potentially offer the benefit of trying a new approach to treatment that might be more effective at preventing the cancer from spreading, especially if earlier chemotherapy proves to be better. However, as with all medical treatments, there are potential risks and side effects associated with chemotherapy and surgery, such as nausea, fatigue, hair loss, or infection. The specific risks will depend on the treatment you receive and will be fully explained to you. You are always free to withdraw from the study at any time, for any reason, without affecting your standard medical care.

Locations (1)

Unversity Hospital Mannheim
Verified postcode
Mannheim, Germany· Recruiting

Common questions

What is 'locally advanced rectal cancer'?

This means your cancer has grown into nearby tissues but hasn't spread to other parts of your body yet.

What does 'chemotherapy before surgery' mean?

It means you'll have medication to treat the cancer for about three months before you have an operation to remove the tumour.

What is the study hoping to find out?

It wants to see if giving chemotherapy earlier (before surgery) is better at stopping the cancer from spreading to other parts of the body, compared to giving it after surgery.

Will I have radiotherapy in this study?

This study is for patients whose specific type of rectal cancer and MRI scans suggest they might not need radiotherapy, focusing instead on different chemotherapy timing.

What happens if I don't want to continue in the study?

You can leave the study at any time without it affecting your medical care.

How to find out more

Ralf-Dieter Hofheinz, Prof. Dr.

ralf.hofheinz@umm.de +49 621 383 Official trial record

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