Not recruiting

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.

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
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
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
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
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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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Amsterdam UMC
Responsive
Amsterdam, The Netherlands
Katholieke Universiteit te Leuven
Responsive
Leuven, Belgium
Leids Universitair Medisch Centrum (LUMC)
Responsive
Leiden, The Netherlands

Trial locations

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Investigated drugs

Based on the provided trial information, this study appears to focus on comparing treatment approaches rather than specific medications. The treatments involved are: Chemoradiotherapy (CRT) This is a combined treatment that uses chemotherapy drugs along with radiation therapy to treat rectal cancer. The chemotherapy makes cancer cells more sensitive to radiation treatment. Short Course Radiotherapy (SCRT) This is a concentrated form of radiation therapy delivered over a shorter time period to treat rectal cancer. It uses high-energy rays to target and destroy cancer cells. Transanal Microsurgery This is a minimally invasive surgical procedure performed through the anus to remove early-stage rectal tumors. It's less extensive than traditional surgery and helps preserve organ function. The trial compares these organ-preserving approaches with total mesorectal excision (traditional radical surgery) for early rectal cancer treatment.

Capecitabine

What is already known about the treatment

Since there are no specific medications mentioned in the provided trial data, I cannot create medication descriptions in the requested format. The trial STAR-TREC appears to be comparing surgical approaches and radiotherapy treatments for early rectal cancer, rather than testing specific medications. The trial mentions "(chemo)radiotherapy" but doesn't specify the chemotherapy agents used. Without specific medication names from the source data, I cannot provide accurate medication descriptions in the requested format. If you'd like, you could provide additional trial data that includes specific medication names, and I would then create descriptions following your format requirements.

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.