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Study of organ preservation using chemoradiotherapy and transanal surgery compared to standard surgery in patients with early rectal cancer (STAR-TREC trial)

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on patients with early stage colorectal cancer, specifically examining different treatment approaches for rectal cancer. The purpose is to evaluate whether organ-preserving treatments can be as effective as traditional surgery. The study compares standard surgical removal of the rectum (called total mesorectal excision) with alternative treatments that aim to preserve the organ using radiation therapy with or without chemotherapy.

The treatment options being studied include chemotherapy using capecitabine, which is given as film-coated tablets taken by mouth. This medication is combined with radiation therapy in some cases. After the radiation treatment (with or without chemotherapy), some patients may undergo a less invasive surgical procedure called transanal microsurgery, which is performed through the natural opening rather than through the abdomen.

During the study, patients will receive one of the treatment approaches and will be monitored for how well the treatment works in controlling the cancer while preserving normal body function. The study will track patients' progress and overall health for several years after treatment. Regular check-ups will include physical examinations and imaging tests to monitor the effectiveness of the treatment.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial evaluation and treatment assignment

    After confirmation of early stage colorectal cancer through biopsy and imaging tests, you will be assigned to one of the treatment options

    Your eligibility will be confirmed based on tumor characteristics and general health status

  2. Step 2

    Treatment pathways

    You will receive one of these treatments:

    - Standard surgery (Total mesorectal excision)

    - Chemoradiotherapy (combination of chemotherapy and radiation)

    - Short-course radiotherapy

    If assigned to chemotherapy, you will receive capecitabine tablets taken by mouth along with radiation therapy

  3. Step 3

    Follow-up period - first month

    Medical evaluations will occur during the first 30 days after treatment completion

    Your doctor will monitor and document any treatment-related effects

  4. Step 4

    Follow-up period - first year

    Health assessments will be conducted at 3 months and 12 months

    You will complete quality of life questionnaires at these visits

  5. Step 5

    Long-term follow-up

    Additional health assessments will occur at 24 and 36 months

    Your doctor will monitor for any signs of cancer return

    The final follow-up will take place at 60 months (5 years) from the start of treatment

Who can join the trial?

10 criteria

  • Patient must have a confirmed rectal cancer (adenocarcinoma) proven by tissue examination (biopsy)
  • Patient's cancer must be at an early stage, as shown by MRI or ERUS imaging tests (special scans that show the tumor's size and spread). The cancer should be classified as TX/T1-3b, NX/N0, MX/M0, which means it's in early stages and hasn't spread extensively
  • The medical team must determine that all these treatment options are suitable for the patient:
    • TME surgery (complete removal of the rectum)
    • CRT (combined chemotherapy and radiation therapy)
    • SCRT (short-course radiation therapy)
    • TEM (minimally invasive surgery through the anus)
    • Patient must have good physical fitness, scoring 0-1 on the ECOG scale (meaning they can perform daily activities with minimal or no assistance)
    • Patient must be able to understand and provide informed consent for participation
    • Both men and women can participate
    • Patient must be an adult (18 years or older)

Who cannot join the trial?

12 criteria

  • Age below 18 years or over 75 years
  • Previous cancer treatment for colorectal cancer
  • Evidence of cancer spread (metastasis) to other parts of the body
  • Pregnancy or breastfeeding
  • Severe heart, lung, liver, or kidney disease that would interfere with treatment
  • Active inflammatory bowel disease (IBD) such as Crohn's disease or ulcerative colitis
  • Mental conditions that prevent understanding of the treatment process
  • Current participation in other clinical trials
  • Previous radiation therapy to the pelvic area
  • Known allergies to medications used in the study
  • Inability to undergo MRI (magnetic resonance imaging) scans
  • Conditions that would prevent regular follow-up visits
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Investigated drugs

Capecitabine is an oral chemotherapy medicine taken by mouth in tablet form. It works by turning into a drug inside the body that stops cancer cells from growing and dividing. In this trial, patients take the tablets while they receive radiation treatment to help shrink the early rectal cancer before any surgery.

(Chemo)radiotherapy combines radiation therapy with a chemotherapy drug (such as capecitabine) to treat the tumor. Radiation uses high‑energy rays aimed at the cancer to damage its DNA, while the chemotherapy makes the cancer cells more sensitive to the radiation. This combined approach is given before any surgery to try to eliminate the tumor while preserving the rectum.

Transanal microsurgery is a minimally invasive operation performed through the anus to remove small pieces of cancerous tissue. It uses tiny instruments and a special camera, allowing the surgeon to precisely cut out the tumor without needing a large abdominal incision. In the study, this surgery is used only if the tumor responds well to the (chemo)radiotherapy.

Total mesorectal excision (TME) is a more extensive surgery that removes the entire rectum and the surrounding fatty tissue (the mesorectum) that may contain cancer cells. It is the standard radical operation for rectal cancer and serves as a comparison to the organ‑preserving approaches being tested in the trial.

Watchful waiting is a strategy where, after (chemo)radiotherapy, doctors closely monitor the patient with regular exams and scans instead of performing immediate surgery. If the cancer shows no signs of returning, the patient can avoid surgery altogether, preserving the normal function of the rectum.

What is already known about the treatment

Capecitabine - Capecitabine is taken by mouth as a film‑coated tablet, usually in a dose calculated per body surface area. It is an approved chemotherapy drug that is well described in medical literature and is used for colorectal cancer and other solid tumors. After swallowing, the tablet is changed in the body to the active drug 5‑fluorouracil, which stops cancer cells from making DNA and therefore slows their growth. It belongs to the antimetabolite class of fluoropyrimidine chemotherapy agents.

Investigated diseases

Early Stage Colorectal Cancer - A condition where abnormal cells form in the tissues of the colon or rectum, specifically in its initial phases. The cancer begins in the innermost layer of the colon or rectum wall and has not spread deeply into the wall or to nearby structures. During early stages, the cancer is limited to the mucosa (inner lining) or has grown into, but not through, the muscular layer of the colon or rectum. At this stage, the cancer cells are confined to the original site, without spreading to lymph nodes or other parts of the body.
Trial detailsLast updated 21 Oct 2026
Age18+ yearsPhasePhase IVTrial ID2024-516106-31-00Protocol codeRG_15-011Estimated enrolment430 patientsSponsorThe University Of Birmingham

sourced from the EU Clinical Trials Register and site verification

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