AuthorisedTherapeutic use (Phase IV)Interventional

Next Generation StaR TREC - Save the rectum by watchful waiting after (chemo)Radiotherapy or Total mesorectal excision for early REctal Cancer?

This research, called StaR TREC, is for people with early-stage rectal cancer. It wants to find out if certain patients can avoid having a big operation by first receiving chemotherapy (Capecitabine tablets) and then being carefully monitored by doctors. This is known as a 'watch and wait' approach. For these patients, the doctors will use various tests, such as MRI scans and endoscopies, to see if the cancer completely disappears a year later. The study will compare this 'watch and wait' method with having surgery. Researchers will also look at important aspects like whether the cancer comes back, how well patients live, and the impact on their daily lives, including bowel, bladder, and sexual function. The goal is to see if we can save the rectum for more patients.

At a glance

Status

Authorised

Phase

Therapeutic use (Phase IV)

Sponsor

Vaestra Goetalandsregionen

Enrolment target

Start

09 Jan 2026

Rectal cancer

What is this study about?

This study, called StaR TREC (Save the rectum by watchful waiting after (chemo)Radiotherapy or Total mesorectal excision for early REctal Cancer?), is an important research project for people diagnosed with early rectal cancer. Rectal cancer can often be treated with surgery to remove the affected part of the bowel. However, this big operation can sometimes have a significant impact on a person's life, including needing a stoma (a bag on the tummy for waste) or changes to how their bowels and bladder work.

Researchers want to see if a different approach, called 'watch and wait', could be a good option for some patients with early rectal cancer. This would involve taking a chemotherapy tablet (Capecitabine) and then being very closely monitored by doctors using scans and other tests. The main goal is to find out what percentage of patients who try this 'watch and wait' method will have their cancer completely disappear after one year without needing surgery.

They will also compare this 'watch and wait' strategy against the standard treatment of surgery. The study will examine many other important things, like how often the cancer comes back, how long people live, and how successfully the rectum can be saved. They will also look at how these different treatments affect a patient's quality of life, including their bladder, bowel, and sexual functions, and whether they need a stoma. This research aims to understand if we can offer some people an effective treatment that avoids a major operation.

Key takeaways

This study evaluates 'watch and wait' for early rectal cancer.
It aims to see if some patients can avoid major surgery.
Chemotherapy tablets (Capecitabine) are part of the 'watch and wait' approach.
Doctors will use MRI scans and other tests to monitor patients.
The study compares 'watch and wait' with standard surgery treatment.
It also looks at quality of life and long-term outcomes.

Who may be eligible?

To be considered for this study, you would need to be an adult, aged 18 or older. No matter your age beyond 18, you could potentially take part.

This study is open to both men and women, as well as people of any gender. The main requirement is that you have been diagnosed with early rectal cancer.

Your medical team, after thoroughly checking your specific situation, will be able to tell you if your type of early rectal cancer fits the criteria for this particular study. They will discuss all the 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.

Are you 18 years old or older?
Have you been diagnosed with early-stage rectal cancer?
Are you male, female, or of any other gender?
Are you able to take chemotherapy tablets?
Are you able to attend regular hospital appointments for scans and check-ups?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, the exact steps will depend on which treatment path you are on (the 'watch and wait' approach or surgery). If you are in the 'watch and wait' group, you would take a chemotherapy tablet called Capecitabine. Throughout the study, you would have regular check-ups, which include MRI scans, doctor examinations, and camera tests (endoscopies) to see how you are responding to treatment. These assessments will be done over a period of at least one year. If you have surgery, you would have follow-up appointments and checks related to your operation. The study will involve several visits to the hospital or clinic for these assessments and to discuss your progress with the study team. The overall duration of your involvement in the study would be ongoing to monitor long-term outcomes like survival.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. A potential benefit of this study is that for some patients, the 'watch and wait' approach might mean avoiding major surgery and its potential side effects, allowing them to keep their rectum. However, every treatment carries risks; Capecitabine, like other chemotherapy drugs, can have side effects, and for those in the 'watch and wait' group, there's a risk the cancer might not completely disappear or could return, potentially requiring surgery later. The study aims to gather important information that could help future patients with rectal cancer. You would have the right to withdraw from the study at any time, for any reason, without it affecting your usual 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
Sweden

Common questions

What is 'early rectal cancer'?

Early rectal cancer means the cancer is small and hasn't spread beyond the wall of the rectum or to distant parts of the body.

What is 'watch and wait'?

This is an approach where instead of immediate surgery, patients are given treatment (like chemotherapy) and then closely monitored to see if the cancer completely disappears without needing an operation.

What is Capecitabine?

Capecitabine is a chemotherapy drug that comes in tablet form and is used to treat various cancers, including rectal cancer.

Will I definitely avoid surgery if I join this study?

Not necessarily. The study is comparing 'watch and wait' with surgery. If you're in the 'watch and wait' group, the aim is to avoid surgery, but if the cancer doesn't disappear or comes back, surgery might still be needed.

What does 'organ preservation' mean?

In this study, 'organ preservation' means being able to keep your rectum (and its normal function) by avoiding the surgery that would remove part of it.