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Study Comparing Short-Course Radiotherapy and Drug Combination for Older Patients with Locally Advanced Rectal Cancer

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What is this study about?

This clinical trial is focused on studying treatments for locally advanced rectal cancer in older patients. The trial compares two treatment approaches: short-course radiotherapy (SCRT) followed by surgery, with or without additional chemotherapy, and total neoadjuvant therapy (TNT), which involves a combination of treatments given before surgery. The main goal is to determine which approach offers a better balance between effectiveness and safety for older patients.

Participants in the study will receive various medications as part of their treatment. These include Capecitabine, Oxaliplatin, and Fluorouracil, which are commonly used in cancer treatment. Additionally, supportive medications such as Ondansetron, Dexamethasone, Folinic Acid, and Metoclopramide may be administered to help manage side effects and improve the overall treatment experience. Some patients may receive a placebo as part of the study design.

The study will follow participants over a period of time to assess outcomes such as overall survival, progression-free survival, and the occurrence of side effects. The trial aims to provide valuable information on the best treatment strategy for older patients with this type of cancer, ultimately helping to improve their quality of life and treatment outcomes.

1 joining the study

Upon joining the study, you will be asked to sign an informed consent form. This document confirms your understanding of the study and your agreement to participate.

You will be required to meet certain criteria, such as being 70 years or older and having a confirmed diagnosis of locally advanced rectal cancer.

2 initial assessment

An initial assessment will be conducted to evaluate your health status. This includes checking your blood counts, liver and kidney function, and overall physical condition.

The assessment ensures that you are fit to undergo the treatment planned in the study.

3 treatment allocation

You will be randomly assigned to one of two treatment groups: short-course radiotherapy (SCRT) followed by surgery, with or without additional chemotherapy, or total neoadjuvant therapy (TNT).

The allocation is random to ensure unbiased results in the study.

4 treatment phase

If you are in the SCRT group, you will receive a short course of radiotherapy. This is followed by surgery, and possibly chemotherapy, depending on your specific case.

If you are in the TNT group, you will receive a combination of chemotherapy drugs such as ondansetron, oxaliplatin, dexamethasone, folinic acid, metoclopramide, and fluorouracil. These are administered intravenously, meaning they are given through a vein, and the treatment schedule will be explained to you in detail.

5 follow-up and monitoring

Throughout the study, regular follow-up appointments will be scheduled to monitor your health and the effects of the treatment.

These appointments will include physical exams, blood tests, and possibly imaging tests to assess the progress of your treatment.

6 end of study participation

At the end of your participation in the study, a final assessment will be conducted to evaluate your overall health and the outcomes of the treatment.

You will be informed about the results and any further steps that may be necessary for your care.

Who Can Join the Study?

  • Age must be 70 years or older.
  • Must have signed an Informed Consent form before any study-related procedures. This means you agree to participate after being informed about the study.
  • Male participants with partners who can become pregnant must agree to use a condom during the study and for at least 6 months after the last dose of study drugs.
  • ECOG performance status: This is a scale to assess how well you can perform daily activities. If you are over 75 years old, your score should be 0 or 1. If you are 75 or younger, your score should be 0, 1, or 2.
  • Must have a confirmed diagnosis of adenocarcinoma of the rectum through a tissue sample test.
  • The tumor must be located below a certain point in the rectum and within 15 cm of the anal verge (the opening of the rectum).
  • Must have operable stage III or high-risk stage II rectal cancer. High-risk tumors have certain features like being large (T4), close to important structures (mesorectal fascia), or having spread to veins outside the rectum. Involvement of certain lymph nodes is also allowed.
  • Must have adequate bone marrow function, which means:
    • Absolute neutrophil count (a type of white blood cell) of 1,500/µL or more.
    • Hemoglobin (a protein in red blood cells) of 9 g/dL or more.
    • Platelets (cells that help with blood clotting) of 100,000/µL or more.
  • Must have adequate liver function, which means:
    • Serum total bilirubin (a substance made by the liver) of 1.5 times the upper limit of normal (ULN) or less. If you have Gilbert’s syndrome, up to 3 times ULN is allowed.
    • AST (SGOT) and ALT (SGPT) (liver enzymes) of 2.5 times ULN or less.
    • Alkaline phosphatase (another liver enzyme) of 2.5 times ULN or less.
  • Must have adequate kidney function, defined by an estimated glomerular filtration rate (GFR) of 30 mL/min/1.73m² or more.
  • Must not have any medical conditions that, in the opinion of the study doctor, would make it unsafe to receive the study treatment or undergo surgery.

Who Cannot Join the Study?

  • Patients with any other type of cancer besides locally advanced rectal cancer cannot participate.
  • Patients who have had previous treatment for rectal cancer are not eligible.
  • Patients with severe heart problems cannot join the study.
  • Patients with uncontrolled high blood pressure are excluded.
  • Patients with severe liver or kidney disease cannot participate.
  • Patients with any active infections are not eligible.
  • Patients who are pregnant or breastfeeding cannot join the study.
  • Patients who are unable to follow the study procedures are excluded.
  • Patients with a history of another cancer within the last 5 years, except for certain skin cancers, are not eligible.
  • Patients who are participating in another clinical trial are excluded.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Centre Hospitalier Epicura Ath Belgium

Other Sites

Site Name City Country Status
Centre hospitalier universitaire de Liege Liege Belgium
Universitair Ziekenhuis Gent Gent Belgium
CHU Saint Pierre Brussels Belgium
AZ Turnhout Turnhout Belgium
Grand Hopital De Charleroi Charleroi Belgium
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur Namur Belgium
Vitaz Sint-Niklaas Belgium
Hopital De Libramont Libramont-Chevigny Belgium
HUmani Montigny-Le-Tilleul Belgium
HUmani Chimay Belgium
Chirec Brussels Belgium
CHU Helora La Louviere Belgium
Institut Jules Bordet Anderlecht Belgium
Gasthuiszusters Antwerpen Antwerp Belgium
University Childrens Hospital Queen Fabiola Brussels Belgium
Cgg Dq Cudtmgcns Hufxorr Aenmk Vuckdr Montigny-Le-Tilleul Belgium
Cfgbkp Hkvesyszeng Rkregmyb Slmblt ec Mgdge Namur Belgium
Ubeazwfwtk Os Aofxlkc Edegem Belgium

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

Trial status

Country Status Recruitment Start
Belgium Belgium
Recruiting
15.01.2024

Trial locations

Investigated drugs:

Short-Course Radiotherapy (SCRT) is a type of radiation treatment used to shrink tumors in the rectum before surgery. It involves giving a high dose of radiation over a short period, usually within a week. This therapy aims to make the tumor smaller and easier to remove during surgery, potentially improving the chances of a successful operation.

Total Neoadjuvant Therapy (TNT) is a comprehensive treatment approach that combines chemotherapy and radiation therapy before surgery. The goal of this therapy is to reduce the size of the cancer and eliminate any cancer cells that may have spread, making the surgery more effective. This approach is designed to improve the overall outcomes for patients by addressing the cancer more aggressively before surgical intervention.

Investigated diseases:

Locally Advanced Rectal Cancer – This is a stage of rectal cancer where the tumor has grown into or through the wall of the rectum and may have spread to nearby tissues or lymph nodes, but not to distant body parts. The disease typically begins with abnormal growth of cells in the rectum, which can form a tumor. As the cancer progresses, it can invade surrounding tissues and organs, potentially affecting bowel function. Symptoms may include changes in bowel habits, rectal bleeding, and abdominal discomfort. The progression of the disease can lead to complications such as obstruction of the bowel or spread to nearby organs. Early detection and monitoring are crucial to managing the disease effectively.

Trial ID:
2023-506703-26-00
Protocol code:
IJB-SHAPERS-ODN-013
Trial Phase:
Therapeutic confirmatory (Phase III)

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