Active not recruitingPHASE2, PHASE3INTERVENTIONAL

Can We Save the Rectum by Watchful Waiting or TransAnal Surgery Following (chemo)Radiotherapy Versus Total Mesorectal Excision for Early REctal Cancer?

This study, called STAR-TREC, is for people with early bowel cancer in the rectum. Normally, this type of cancer is treated with major surgery. However, this surgery can sometimes lead to patients needing a stoma bag, either temporarily or permanently. This study wants to find out if using radiotherapy treatments, sometimes combined with medication, can avoid the need for this big surgery and allow patients to keep their rectum. Researchers will compare standard surgery with two different radiotherapy approaches, looking at how well they treat the cancer, preserve the rectum, and how they affect a patient's quality of life.

At a glance

Status

Active not recruiting

Phase

PHASE2, PHASE3

Sponsor

University of Birmingham

Enrolment target

380

Start

14 Jun 2017

Estimated completion

01 Aug 2028

Adenocarcinoma of the Rectum

What is this study about?

Each year in the UK, many people are diagnosed with bowel cancer, and a significant number of these cancers are found in the rectum. The usual treatment for early rectal cancer is a major operation called Total Mesorectal Excision (TME) surgery. While this surgery is very good at removing the cancer, it can sometimes mean that patients need a stoma, which is a bag attached to the outside of the body to collect waste. For some, this stoma is temporary, but for others, it can be permanent. Doctors are looking for ways to treat rectal cancer that are just as effective but might lead to fewer major changes in a patient's life, like avoiding a stoma.

This study, called STAR-TREC, is exploring if we can avoid this major surgery by using other treatments. It’s comparing the standard TME surgery with two types of radiotherapy treatments. One radiotherapy approach involves a longer course of treatment combined with a medication called capecitabine. The other is a shorter course of radiotherapy. The aim is to see if these radiotherapy treatments can shrink the cancer enough to allow patients to keep their rectum, potentially avoiding the need for a stoma. The study wants to understand not only how well these treatments work against cancer but also how they affect a patient's health and daily life.

The study involves different stages. Patients who prefer to try to save their rectum will be randomly assigned to receive one of the two radiotherapy treatments. After radiotherapy, doctors will carefully check how the cancer has responded. If the cancer has gone away completely, patients might not need further surgery and will be monitored closely. If there’s still some cancer, or if patients preferred surgery from the start, they would then have the standard TME operation. This careful approach helps doctors learn which treatment options offer the best outcomes with the fewest side effects for patients with early rectal cancer.

Key takeaways

The study explores alternatives to major surgery for early rectal cancer.
It compares standard surgery with two types of radiotherapy aiming to save the rectum.
The goal is to find treatments that are effective with fewer life-changing side effects like a stoma.
Careful monitoring is key, with surgery as an option if organ-saving treatments aren't fully effective.
Patient choice regarding treatment path is an important aspect of the study design.

Who may be eligible?

To join this study, you generally need to have been diagnosed with a type of bowel cancer called adenocarcinoma in your rectum. Your cancer needs to be at an early stage, which means it hasn't spread too widely, and doctors will check this using scans like MRI.

Before you can take part, a team of specialists will look at your case to make sure that all the different treatment options being studied (standard surgery, the two types of radiotherapy, and a smaller surgery called TEM) are suitable for you. You also need to be generally well enough to take part in the study activities.

There are also some things that would mean you couldn't join. For example, if you have other cancers that are likely to cause problems, or if your rectal cancer has already spread to other parts of your body. Your doctor will be able to check all these details with 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.

Do I have adenocarcinoma of the rectum?
Has my doctor confirmed my cancer is at an early stage and hasn't spread widely?
Am I generally well enough to take part in medical treatments?
Are all the different treatment options (surgery and radiotherapy types) considered suitable for me by my medical team?
Am I aged 16 years or older?

Answer every question to see your result.

What does participation involve?

If you join the STAR-TREC study, what happens next depends on what you and your doctors decide. You might choose to try one of the organ-saving treatments (radiotherapy) or go straight to standard surgery. If you choose the organ-saving route, you'll be randomly assigned to either a long course of combined radiotherapy and medication, or a short course of radiotherapy. Both involve attending hospital for your treatment sessions, typically five days a week over several weeks.

Throughout the study, you'll have regular check-ups, including physical exams, endoscopies (where a small camera is used to look inside), and MRI scans. These checks are very important to see how your cancer is responding to treatment. Depending on these results, you might move to close monitoring, or if needed, have surgery to remove any remaining cancer. The study will also ask you to report on your own health and how you feel, to understand the impact of treatments on your quality of life. The total duration of your involvement, including follow-up, will vary depending on your treatment path and how your body responds.

Potential risks and benefits

Participating in this study might offer you benefits, such as access to innovative treatments that aim to save your rectum and avoid a permanent stoma bag, potentially improving your quality of life. However, like any medical treatment, there are potential risks and side effects associated with both surgery and radiotherapy, which your doctors will discuss with you in detail. There's also the possibility that the organ-saving treatments might not fully remove your cancer, and you may still need surgery later. You are free to withdraw from the study at any time without affecting your usual medical care.

Locations (5)

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

University Hospital UZ Leuven
Verified postcode
Leuven, Belgium
Odense University Hospital
Verified postcode
Odense, Denmark
Radboud University medical center
Verified postcode
Nijmegen, Netherlands
Region Stockholm, Onkologkliniken Södersjukhuset AB
Verified postcode
Stockholm, Sweden
University of Birmingham
Verified postcode
Birmingham, United Kingdom

Common questions

What is a stoma, and why does this study want to avoid it?

A stoma is an opening on your tummy where a bag is attached to collect bodily waste. This study aims to find ways to avoid a stoma, as it can significantly impact a person's daily life, although it is sometimes necessary.

What does 'organ-saving' mean in this study?

Organ-saving means treatments that aim to remove the cancer without taking away the whole organ, in this case, the rectum. This study explores if radiotherapy can achieve this, instead of major surgery.

What is radiotherapy?

Radiotherapy uses high-energy rays to kill cancer cells. In this study, it's used to treat rectal cancer, sometimes with additional medication.

Will I definitely avoid surgery if I join the organ-saving part of the study?

Not necessarily. The goal is to avoid major surgery, but if the radiotherapy doesn't fully clear the cancer, surgery might still be needed later to completely remove it.

Who is funding this research?

Information on specific funding bodies is not detailed in the provided brief, but clinical trials are typically funded by research organisations, charities, or sometimes pharmaceutical companies. You can ask the study team for more details.