Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not recruiting

Study Comparing Short Course Radiotherapy and Chemoradiotherapy with Fluorouracil, Calcium Folinate, and Capecitabine for Intermediate and High-Risk Rectal Cancer Patients

Fast replyRegistered drug
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

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

This clinical trial is focused on studying treatments for intermediate and high-risk rectal cancer. The study compares two different approaches: short course radiotherapy and chemoradiotherapy, both followed by additional chemotherapy. The goal is to explore the possibility of preserving the rectum without major surgery or the need for a stoma, which is an opening created in the abdomen to allow waste to leave the body. The trial involves several medications, including Fluorouracil, Calcium Folinate Pentahydrate, Capecitabine, and Oxaliplatin. These medications are used in different forms, such as injections and tablets, to help treat the cancer.

The purpose of the study is to determine if these treatments can improve the rate of organ preservation, meaning the rectum remains intact without the need for major surgery. Participants will receive either the short course radiotherapy or chemoradiotherapy, followed by consolidation chemotherapy, which is additional treatment to help strengthen the effects of the initial therapy. The study will monitor the participants over a period to assess the effectiveness of the treatments in preserving the rectum and improving survival rates.

Throughout the study, participants will undergo various procedures, including MRI scans, to evaluate the progress of the treatment. The trial aims to improve the 3-year organ preservation rate from 30% to 40% in patients receiving the investigational treatment. This research is part of a larger effort by the German Rectal Cancer Study Group to find better ways to treat rectal cancer while minimizing the need for invasive surgeries.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on specific criteria, including a diagnosis of intermediate or high-risk rectal cancer.

    Initial assessments include MRI and possibly endoscopic ultrasound to determine the extent of the cancer.

  2. Step 2

    Treatment phase 1: radiotherapy or chemoradiotherapy

    Participants receive either short course radiotherapy or chemoradiotherapy. The choice depends on the specific characteristics of the cancer as determined by MRI.

    This phase aims to reduce the size of the tumor and prepare for further treatment.

  3. Step 3

    Treatment phase 2: consolidation chemotherapy

    Following the initial treatment, consolidation chemotherapy is administered.

    Medications include fluorouracil and calcium folinate pentahydrate, both given as solutions for injection through intravenous use.

    Additional medication, capecitabine, is provided in the form of film-coated tablets for oral use.

    Another medication, oxaliplatin, is administered as a solution for infusion intravenously.

  4. Step 4

    Monitoring and assessment

    Regular monitoring occurs to assess the response to treatment. This includes imaging studies and clinical evaluations.

    The goal is to determine if the cancer has responded sufficiently to avoid major surgery.

  5. Step 5

    Decision on organ preservation

    Based on the response to treatment, a decision is made regarding organ preservation.

    The primary aim is to maintain the rectum intact without major surgery or the need for a stoma.

  6. Step 6

    Follow-up and long-term monitoring

    Participants are followed up regularly to monitor for any signs of cancer recurrence or complications.

    The study aims to improve the rate of organ preservation and assess long-term outcomes such as survival and quality of life.

Who can join the trial?

14 criteria

  • Both men and women can participate.
  • Must have a confirmed diagnosis of **rectal adenocarcinoma**, which is a type of cancer in the rectum, located 0 to 12 cm from the **anocutaneous line** (the area where the anus meets the skin) as measured by a special procedure called **rigid rectoscopy**.
  • Must undergo a special imaging test called **high-resolution MRI** of the pelvis to check the local area of the cancer.
  • The MRI must show at least one high-risk condition, such as:
    • Any **cT3 tumor** if it is less than 6 cm from the anocutaneous line.
    • **cT3c/d tumor** in the middle third of the rectum (6-12 cm) with evidence of the tumor spreading more than 5 mm into the surrounding fat.
    • **cT3 tumor** with clear signs of cancer in nearby lymph nodes.
    • **cT4 tumors** or any tumor in the middle/low third of the rectum with clear signs of cancer in nearby lymph nodes or close to important structures.
    • Signs of cancer spreading into nearby veins, known as **extramural venous invasion (EMVI+).**
    • If the MRI is not clear, a **transrectal endoscopic ultrasound (EUS)** may be used to rule out early-stage tumors.
    • A **spiral-CT scan** of the abdomen and chest is needed to ensure the cancer has not spread to distant parts of the body.
    • Participants must be at least 18 years old, with no upper age limit.
    • Must have a **WHO/ECOG Performance Status** of 0 or 1, which means the person is fully active or has some symptoms but can still carry out light work.
    • Must have adequate blood, liver, kidney, and metabolic function, with specific requirements for blood cell counts and other lab values.
    • Must provide informed consent, meaning they understand the study and agree to participate.

Who cannot join the trial?

6 criteria

  • Patients who have had any major surgery other than a small, local removal of tissue after joining the study.
  • Patients who have experienced any growth of cancer in the local area that cannot be removed with surgery.
  • Patients who need a stoma, which is an opening made in the body to help with waste removal, due to treatment side effects or poor function.
  • Patients who are not able to have a stoma removed within 6 months after finishing treatment.
  • Patients who have experienced any growth of cancer in the local area that requires a major surgery to remove it.
  • Patients who have passed away during the study period.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

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

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

  • Short Course Radiotherapy

    is a treatment that uses high-energy rays to target and kill cancer cells in the rectum. This therapy is given over a short period and aims to shrink the tumor before any further treatment.

  • Chemoradiotherapy

    combines chemotherapy and radiotherapy. Chemotherapy uses drugs to destroy cancer cells, while radiotherapy uses high-energy rays. Together, they work to make the cancer cells more sensitive to the radiation, enhancing the treatment's effectiveness.

  • Consolidation Chemotherapy

    involves using chemotherapy drugs after initial treatments to further reduce the number of cancer cells. This step aims to consolidate the gains made by the previous treatments and help prevent the cancer from returning.

  • Selective Organ Preservation

    is a strategy to avoid major surgery and maintain the function of the rectum. This approach focuses on preserving the organ by using less invasive treatments, allowing patients to keep their rectum intact if the cancer responds well to the initial therapies.

What is already known about the treatment

  • Short Course Radiotherapy

    This treatment is administered as a series of radiation sessions aimed at the rectal area. It is currently being studied in clinical trials for its effectiveness in treating intermediate and high-risk rectal cancer. The main therapeutic indication is to reduce tumor size and improve organ preservation rates. The mechanism of action involves damaging the DNA of cancer cells, preventing them from growing and dividing. It is classified as a form of radiotherapy.

  • Chemoradiotherapy

    This treatment combines chemotherapy and radiotherapy, administered either orally or intravenously, along with targeted radiation sessions. It is under investigation in clinical trials for its potential benefits in treating intermediate and high-risk rectal cancer. The primary therapeutic indication is to enhance the effectiveness of radiation by sensitizing cancer cells to it. The mechanism of action involves chemotherapy drugs interfering with cancer cell division, while radiation damages their DNA. It is classified as a combination therapy involving both chemotherapy and radiotherapy.

Investigated diseases

Rectal Cancer – Rectal cancer is a type of cancer that begins in the rectum, which is the last several inches of the large intestine before the anus. It often starts as a growth on the inner lining of the rectum, known as a polyp, which can become cancerous over time. The disease is categorized into different stages based on how far it has spread, with intermediate and high-risk stages indicating more advanced progression. As the cancer grows, it can invade nearby tissues and organs, potentially leading to symptoms such as changes in bowel habits, rectal bleeding, and abdominal discomfort. The progression of rectal cancer can also involve the spread to lymph nodes and other parts of the body, known as metastasis. Early detection and monitoring are crucial for managing the disease and preventing further complications.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-511577-29-01Protocol codeACO/ARO/AIO-18.1Estimated enrolment702 patientsSponsorGoethe University Frankfurt

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

ClinicalTrials.eu

Every clinical trial in Europe, in plain language.

Explore the full ecosystem of clinical research in Europe.

Search trials

Legal notice · Published by CTIN POLAND sp. z o.o., ul. rtm. Witolda Pileckiego 67/109, 02-781 Warsaw, Poland · KRS 0001111334 · REGON 528919042 · NIP 9512598637

© 2026 Clinical Trials EU – European Clinical Trials Information Network

GDPR compliance, ISO 9001 and ISO 27001 certified (LL-C Certification)

On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).