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

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What is this study about?

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.

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 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 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 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 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 Study?

  • 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 Study?

  • 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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Frisius Heerenveen The Netherlands
Katholieke Universiteit te Leuven Leuven Belgium

Other Sites

Site Name City Country Status
Isala Klinieken Stichting Zwolle The Netherlands
Amphia Hospital Breda The Netherlands
Algemeen Ziekenhuis Groeninge Kortrijk Belgium
Diakonessenhuis Stichting Utrecht The Netherlands
Region Skane Skanes Universitetssjukhus Lund Sweden
Catharina Ziekenhuis Stichting Eindhoven The Netherlands
Az St-Jan Brugge-Oostende A.V. Brugge Belgium
Stichting Radboud University Medical Center Nijmegen The Netherlands
Gasthuiszusters Antwerpen Antwerp Belgium
Deventer Ziekenhuis Deventer The Netherlands
Netherlands Cancer Institute Amsterdam The Netherlands
Queen Silvia Childrens Hospital – Sahlgrenska University Hospital – Vaestra Goetalandsregionen Gothenburg Sweden
Spaarne Gasthuis Hoofddorp The Netherlands
Soedersjukhuset AB Stockholm Sweden
Lwuwb Umkrsjlymppx Mlpoyak Cketrmq (xinhn Leiden The Netherlands
Szqythhpr Mgfggzc Zowseezpvf Groningen The Netherlands
Lzueugvvpr Zazexrjapd Rrkzedrt Roermond The Netherlands
Asfgegrto Uaf Amsterdam The Netherlands
Slf Ewozegvic Hplbaeqm Tjcntvq Tilburg The Netherlands

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
01.11.2024
Sweden Sweden
Not recruiting
01.11.2024
The Netherlands The Netherlands
Not recruiting
01.11.2024

Trial locations

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.

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 ID:
2024-516106-31-00
Protocol code:
RG_15-011
Trial Phase:
Therapeutic use (Phase IV)

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