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Study of drug combination with radiotherapy versus radiotherapy alone for locally advanced rectal cancer in patients 75 years and older

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What is this trial about?

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

This study involves patients aged 75 years and older who have been diagnosed with rectal adenocarcinoma, which is a type of cancer that develops in the rectum. The rectum is the last part of the large intestine before the anus. The study focuses on patients whose cancer has grown to a certain size or depth in the rectal wall, making it locally advanced. The treatments being evaluated include short-course radiotherapy, which is a form of radiation treatment given over a shorter period of time, followed by chemotherapy using a combination of medications called FOLFOX, which consists of oxaliplatin, fluorouracil, and either folinic acid or calcium levofolinate. These medications are given through a vein to help shrink the cancer. The study will compare two treatment approaches: one group will receive radiotherapy followed by six cycles of chemotherapy, while the other group will receive only radiotherapy without additional chemotherapy.

The purpose of this study is to determine which treatment approach is more effective in preserving the organ, meaning avoiding the need for surgery to remove the rectum. The study will track patients for 24 months to see how many are able to avoid having surgery called total mesorectal excision, which involves removing the rectum and surrounding tissue. After receiving their assigned treatment, patients will be monitored through various examinations including physical examinations of the rectum, imaging scans using magnetic resonance imaging and computed tomography, and endoscopic evaluations where a camera is used to look inside the rectum. The study will assess whether the cancer has completely disappeared, partially shrunk, or remained stable, and whether patients can be managed without immediate surgery through careful monitoring.

Throughout the study, doctors will evaluate the safety of the treatments by monitoring for side effects and complications. They will also assess how well patients are functioning in their daily lives, their bowel function, and their overall quality of life using questionnaires at several time points during the study. For patients who do require surgery, either as part of the initial treatment plan or later if the cancer returns, the study will evaluate surgical outcomes and any complications that may occur. The study will also track whether the cancer spreads to other parts of the body, whether it returns in the area where it was originally located, and overall survival rates at 24 months.

The research process

The trial runs in 8 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial radiation treatment

    Your treatment will begin with short-course radiotherapy, which is a type of radiation treatment delivered over a brief period.

    This radiation treatment is designed to target the rectal cancer area.

  2. Step 2

    Treatment path assignment

    After completing the radiation treatment, your treatment path will be determined by the group assignment in the study.

    One path includes additional medication treatment with chemotherapy, while the other path does not include chemotherapy after radiation.

    If assigned to the chemotherapy path, you will receive six cycles of FOLFOX4s chemotherapy.

  3. Step 3

    Chemotherapy treatment (if assigned to this path)

    The chemotherapy regimen called FOLFOX4s consists of four medications given through a vein: oxaliplatin, calcium levofolinate (or folinic acid), and fluorouracil.

    You will receive a total of six cycles of this chemotherapy combination.

    Each medication will be administered through intravenous infusion, meaning it will be delivered directly into your vein.

    The exact timing and duration of each chemotherapy cycle will be determined by your treatment schedule.

  4. Step 4

    Response evaluation at 21 weeks

    At 21 weeks after starting treatment, your response to treatment will be evaluated.

    This evaluation will include several examinations: an endoscopic examination (a procedure using a flexible tube with a camera to look inside your rectum), a digital rectal examination (physical examination of the rectum), a pelvic MRI scan (magnetic resonance imaging to create detailed pictures of your pelvis), and a chest and abdominal CT scan (computed tomography to check for any spread of cancer).

    The purpose is to determine if your cancer has responded completely to the treatment.

  5. Step 5

    Follow-up assessments at 3 months

    At 3 months after radiation treatment, you will undergo assessments to evaluate your bowel function and quality of life.

    Your bowel function will be assessed using a questionnaire called the LARS score.

    Your quality of life will be evaluated using two questionnaires: QLQ-C30 and ELD-14.

    A geriatric assessment will also be performed using the G Code questionnaire.

  6. Step 6

    Follow-up assessments at 12 months

    At 12 months after joining the study, you will have another round of assessments.

    Your bowel function will be assessed again using the LARS score.

    Your quality of life will be evaluated using the QLQ-C30 and ELD-14 questionnaires.

    A geriatric assessment will be performed using the G Code questionnaire.

  7. Step 7

    Follow-up assessments at 24 months

    At 24 months after joining the study, you will undergo final assessments.

    Your bowel function will be assessed using the LARS score.

    Your quality of life will be evaluated using the QLQ-C30 and ELD-14 questionnaires.

    A geriatric assessment will be performed using the G Code questionnaire.

    The study will evaluate whether you have avoided major surgery to remove the rectum, known as total mesorectal excision or TME.

  8. Step 8

    Ongoing monitoring throughout the study

    Throughout the study period, you will be monitored for any side effects from the treatment.

    If your cancer responds completely to treatment, you may be followed with a monitoring approach called watch and wait, which involves regular examinations without immediate surgery.

    If surgery becomes necessary at any point, it will be performed according to your medical needs.

    Regular blood tests will be conducted to monitor your blood cell counts, liver function, and kidney function.

Who can join the trial?

12 criteria

  • You must have a confirmed diagnosis of adenocarcinoma of the rectum, which is a type of cancer that starts in the cells lining the rectum, confirmed by examining tissue under a microscope
  • You must be enrolled in a Social Security System or equivalent health insurance program
  • You must sign a written consent form before any study procedures begin. If you are unable to sign yourself, a trusted person of your choice who is not involved in the study can sign on your behalf
  • You must be willing and able to follow all study requirements, including attending scheduled visits, following the treatment plan, and completing laboratory tests
  • You must be 75 years old or older
  • Your WHO performance status must be 0 or 1, which means you are able to carry out normal activities or have only slight restrictions in physically demanding activities
  • Your tumor must meet specific size and depth requirements on your pelvic MRI scan, which is a special imaging test of the pelvic area: either a cT3a-b tumor larger than 5 cm in diameter, or a cT3c-d or cT4 tumor
  • Your overall health must be good enough to undergo major pelvic surgery and receive FOLFOX chemotherapy, which is a combination of cancer-fighting drugs
  • The lower part of your tumor must be located within 10 cm from the anal opening, measured by pelvic MRI scan
  • You must receive approval from a specialist doctor who focuses on cancer care in elderly patients, called an oncogeriatrician
  • Your blood tests must show adequate function with specific levels: neutrophils (a type of white blood cell) at least 1500 per cubic millimeter, platelets (cells that help blood clot) at least 100,000 per cubic millimeter, hemoglobin (protein that carries oxygen in blood) at least 10 grams per deciliter, total bilirubin (substance from broken down red blood cells) no more than 1.5 times the upper normal limit, alkaline phosphatases (enzymes in liver and bones) no more than 1.5 times the upper normal limit, creatinine clearance (measure of kidney function) greater than 50 milliliters per minute, and AST and ALT (liver enzymes) no more than 2.5 times the upper normal limit
  • If you are male, you must agree to use adequate birth control methods during treatment and for at least 12 months after finishing treatment with oxaliplatin

Who cannot join the trial?

4 criteria

  • The study information does not list specific reasons why patients cannot participate in this clinical trial
  • If you have questions about whether you can join this study, your doctor will need to review your individual medical situation
  • General factors that often prevent participation in cancer treatment studies may include having other active cancers, severe heart or kidney problems, or being unable to safely receive the planned treatments
  • Your doctor will check if the study treatments, which include radiotherapy (treatment using radiation to kill cancer cells), FOLFOX chemotherapy (a combination of cancer-fighting drugs), and total mesorectal excision surgery (an operation to remove the rectum and surrounding tissue), are safe for you
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Investigated drugs

  • FOLFOX4

    is a combination chemotherapy treatment that uses several anti-cancer drugs together to fight cancer cells. This treatment is commonly used for colorectal cancers and works by stopping cancer cells from growing and dividing.

  • Short-course radiotherapy

    is a radiation treatment given over a brief period of time. It uses high-energy rays to damage cancer cells in the rectum and help shrink the tumor before other treatments or surgery.

What is already known about the treatment

FOLFOX – FOLFOX is a combination chemotherapy treatment given through a vein that contains three different cancer-fighting drugs: folinic acid (leucovorin), fluorouracil, and oxaliplatin, which work together to stop cancer cells from growing and dividing. This treatment is widely used and well-established in medical practice for treating various types of colorectal cancers, including rectal cancer. The drugs in FOLFOX work by interfering with the cancer cells' ability to copy their genetic material and build new proteins, which are essential processes for the cells to multiply and survive. In this clinical trial, FOLFOX is being tested as part of a treatment plan for elderly patients with advanced rectal cancer to help preserve organ function and improve treatment outcomes.

Investigated diseases

Rectal Adenocarcinoma – Rectal adenocarcinoma is a type of cancer that develops in the rectum, which is the last portion of the large intestine before the anus. This cancer begins in the glandular cells that line the inner wall of the rectum and produce mucus. The disease often starts as small growths called polyps that can gradually transform into cancer over time. As the tumor grows, it can penetrate deeper into the layers of the rectal wall and potentially spread to nearby lymph nodes. In locally advanced stages, the cancer extends beyond the inner lining into the muscle layers or outer wall of the rectum. Without intervention, the disease may continue to grow locally and can spread to other parts of the body through the bloodstream or lymphatic system.
Trial detailsLast updated 2 Oct 2026
Age65+ yearsPhasePhase IIITrial ID2025-521619-37-00Protocol codeUC-GIG-2408Estimated enrolment160 patientsSponsorUnicancer

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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).