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 study about?

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.

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 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 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 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 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 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 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 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 Study?

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 Study?

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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Centre Hospitalier Regional Et Universitaire De Brest	Brest	France
CHU Grenoble Alpes	La Tronche	France
Institut De Cancerologie De Lorraine	Vandoeuvre Les Nancy	France
Comite Entreprise Paul Papin	Angers	France

Other Sites

Site Name	City	Country
Centre Antoine Lacassagne	Nice	France
Hopitaux Universitaires Pitie Salpetriere	Paris	France
Hopital Tenon	Paris	France
Centre Hospitalier Universitaire De Poitiers	Poitiers	France
Institut Godinot	Reims	France
Centre Hospitalier Universitaire De La Reunion	St Denis	France
Hopital Prive Jean Mermoz	Lyon	France
Centre Hospitalier De Dax	Dax	France
Groupe Hospitalier Diaconesses Croix Saint Simon	Paris	France
Centre Regional Lutte Contre Le Cancer	STRASBOURG, Alsace	France
Centre De Lutte Contre Le Cancer Eugene Marquis	Rennes	France
Czjvxz Hhheykbvesk Uqrgijcvhtbwb Rrrgp	Reims	France
Addprsbfht Pahulvrk Hjcouokx Db Pkswf	Paris	France
Cdbnea Hbwrptahtum Dc Cblqairtarm	Carcassonne	France
Hryulvp Hdrpp Mgzwnm &esdbll 1 rzr Gkgxovk Ekhvqn	Creteil	France
Issugtmq Puzhvxjfuoiryrm Ceqxjl Crxfmw	Marseille	France
Cntaja Oivyw Lfpjvff	Lille	France

Trial status

Country	Status	Recruitment Start
France	Not yet recruiting	15.01.2026

Trial locations

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.

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 ID:

2025-521619-37-00

Protocol code:

UC-GIG-2408

NCT ID:

NCT07118800

Trial Phase:

Therapeutic confirmatory (Phase III)

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

What is this study about?

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