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?

Rectal cancer affects the last part of the large bowel. The standard treatment is major surgery to remove the rectum. While effective, this operation carries risks and often means living with a stoma bag, either temporarily or permanently. The STAR-TREC study investigates whether people with early-stage rectal cancer can safely avoid this major operation. In this trial, patients can choose between standard surgery and an organ-saving approach. Those choosing organ preservation receive either a short, one-week course of radiotherapy or a five-week course of radiotherapy alongside chemotherapy tablets. Doctors then closely monitor the tumour. If it disappears completely, patients are carefully watched rather than operated on. If a small mark remains, a minor procedure through the back passage may remove it. The goal is to see if this gentler approach cures the cancer while keeping normal bowel function.

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?

When bowel cancer is found in the rectum (the lower part of the bowel), the usual treatment is an operation called Total Mesorectal Excision (TME). This major surgery removes the rectum and surrounding tissue. It cures many people, but it can be a tough operation to recover from. In some cases, it leaves patients needing a stoma bag on their abdomen to collect waste, and it can cause lasting changes to bowel, urinary, and sexual function.

Doctors are now finding more rectal cancers at a very early stage, often through national screening programmes. Because these early tumours are small and have not spread, researchers want to know if major surgery is truly necessary for everyone, or if gentler treatments can cure the cancer just as well while saving the rectum.

The STAR-TREC trial is exploring this question. Patients can decide whether they prefer standard surgery or a treatment designed to save their bowel. Those who choose the organ-saving route are randomly placed into one of two groups: a short course of high-dose radiotherapy over five days, or a longer five-week course of radiotherapy combined with daily chemotherapy tablets (capecitabine).

After radiotherapy, your team will use scans and camera examinations to see how the tumour responds. If the cancer clears completely, you can avoid surgery entirely and enter a programme of close monitoring called 'watchful waiting'. If a small amount remains, surgeons can often remove just the leftover tissue through the back passage using a gentle technique, avoiding major surgery.

Key takeaways

STAR-TREC is testing whether early rectal cancer can be cured without major surgery.
Patients can choose between standard surgery or an organ-saving approach.
Organ-saving treatment uses radiotherapy (either 5 days or 5 weeks) to shrink the tumour.
If the tumour clears completely, patients are monitored closely without needing an operation.
Avoiding major surgery can help preserve bowel control and prevent the need for a stoma bag.

Who may be eligible?

This trial is for adults aged 16 and over who have been diagnosed with an early, small adenocarcinoma of the rectum. The tumour must be 40 millimetres (4 cm) or smaller, and MRI scans must confirm that the cancer has not spread deeply into nearby tissues, lymph nodes, or other organs such as the liver or lungs.

To take part, you must be well enough to undergo either radiotherapy or surgery, and your local hospital specialist team (MDT) must agree that all the trial treatments are safe and suitable options for you. If you choose the organ-saving route and are able to have children, you must be willing to use reliable contraception during treatment and for six months afterwards.

You will not be able to take part if your tumour is large, has spread to lymph nodes, or is very close to the outer edge of the bowel wall. You may also be unable to join if you have had another cancer in the past three years that carries a high risk of returning, or if you cannot safely have an MRI scan.

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.

I have been diagnosed with early-stage adenocarcinoma of the rectum.
My tumour is 40 mm (4 cm) or smaller.
My scans show the cancer has not spread to my lymph nodes or other parts of my body.
I am aged 16 or over and generally active and well.
My doctor has confirmed that I am fit enough for radiotherapy and surgery.

Answer every question to see your result.

What does participation involve?

If you join the STAR-TREC study, you will first choose between having standard surgery or an organ-saving treatment. If you choose organ preservation, a computer will assign you by chance to either a 5-day course of radiotherapy or a 5-week course of radiotherapy taken with chemotherapy tablets.

Around 11 to 13 weeks after starting treatment, you will have an MRI scan and a camera check (endoscopy) of your rectum to see how well the tumour has responded. If it is shrinking well, you will be checked again at 16 to 20 weeks. If the cancer has completely cleared, you will not need surgery and will be followed up closely with regular scans and checks. If a small amount remains, you may have a minor procedure called transanal endoscopic microsurgery (TEM) to remove just the remaining area through your back passage.

If the cancer does not shrink enough at any check, your doctors will arrange standard surgery to ensure you receive the safest treatment. Overall, you will be followed up for several years with planned visits, bowel examinations, and quality-of-life questionnaires.

Potential risks and benefits

The main benefit of taking part is the chance to avoid major bowel surgery and the potential need for a temporary or permanent stoma bag. However, radiotherapy can cause short-term side effects such as tiredness, skin irritation, looser stools, and bladder discomfort. Chemotherapy tablets can cause sickness or sore hands and feet. There is also a risk that the tumour may not shrink completely or could return, meaning you might still need major surgery later. Joining is completely your decision, and you are free to leave the trial at any point without it affecting your NHS care.

Locations (5)

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

Will I definitely avoid having a stoma bag if I join?

No, it cannot be guaranteed. While the goal is to avoid major surgery and a stoma, some tumours do not shrink enough with radiotherapy. If this happens, your team will recommend standard surgery to keep you safe.

Can I choose between the two radiotherapy treatments?

You can choose between having standard surgery or the organ-saving route. If you choose the organ-saving route, a computer randomly selects whether you have the short 5-day course or the longer 5-week chemoradiotherapy course.

What happens if the cancer comes back during watchful waiting?

You will have very frequent scans and camera checks. If there is any sign of the cancer returning, your surgical team will quickly step in to offer standard surgery or other curative treatments.

How does transanal surgery work?

Transanal endoscopic microsurgery (TEM) is done entirely through your back passage using tiny instruments. There are no cuts made on your tummy, which means a much faster recovery than standard bowel surgery.

Do I have to take time off work?

You may need some time off during radiotherapy or if you need minor surgery, mainly due to appointments and mild side effects like tiredness. Your care team will advise you based on the treatment you receive.