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Study on Aspirin and Metformin for Patients with Locally Advanced Rectal Cancer

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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 locally advanced stage II/III rectal cancer. The trial will explore the effects of using aspirin, metformin, or both, in combination with standard treatments. The standard treatments include chemotherapy, which uses drugs to kill cancer cells, and chemoradiotherapy, which combines chemotherapy with radiation therapy to target cancer more effectively.

The purpose of the study is to assess how well these treatments work in shrinking the tumor before surgery. Participants will receive either the standard treatment alone or the standard treatment combined with aspirin, metformin, or both. The study will help determine if adding these medications can improve the response of the tumor to treatment.

Participants in the study will undergo a series of treatments over a period of time, with regular monitoring to assess the tumor's response. The study aims to find out if these additional treatments can lead to better outcomes, such as reducing the size of the tumor or improving the chances of successful surgery. The trial will also look at other factors like survival rates and quality of life for participants.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Induction chemotherapy
The first stage involves receiving induction chemotherapy. This treatment uses medications to shrink the tumor before surgery.
The medications used include oxaliplatin, administered through a vein (intravenous use), and capecitabine, taken by mouth (oral use).
Step 2
Chemoradiotherapy
Following induction chemotherapy, the next step is chemoradiotherapy. This combines chemotherapy with radiation therapy to further reduce the tumor size.
During this phase, capecitabine continues to be taken orally.
Step 3
Experimental interventions
In addition to standard treatments, there are experimental interventions involving aspirin and/or metformin, both taken orally.
These medications are used to assess their effect on tumor response when combined with the standard treatment.
Step 4
Surgery
After completing the chemoradiotherapy, surgery is performed to remove the tumor. This procedure is known as total mesorectal excision.
Step 5
Follow-up
Post-surgery, regular follow-up appointments are scheduled to monitor recovery and check for any signs of cancer recurrence.
These appointments may include physical exams, imaging tests, and discussions about any side effects or complications.

Who can join the trial?

5 criteria

The patient must have a confirmed diagnosis of **adenocarcinoma of the rectum**. This means that a type of cancer has been found in the rectum through a procedure called an **endoscopic biopsy**, which involves taking a small tissue sample for testing.
The cancer must be **locally advanced**, which means it is in **stage II or III**. This is determined by specific tests, including an **MRI** (a type of scan) of the pelvis and a **contrast-enhanced CT** (another type of scan) of the abdomen and chest.
The patient must be able to undergo **induction chemotherapy** (a treatment using drugs to kill cancer cells), **chemoradiotherapy** (a combination of chemotherapy and radiation therapy), and a surgery called **total mesorectal excision (TME)**, which involves removing the rectum and surrounding tissue.
The patient must be between the ages of 18 and 64.
Both male and female patients are eligible to participate.

Who cannot join the trial?

8 criteria

Patients with any other type of cancer besides locally advanced stage II/III rectal cancer cannot participate. This means the cancer is in the rectum and has spread to nearby areas but not to distant parts of the body.
Patients who are not in the specified age range cannot participate. The age range is typically defined by the study, so it's important to check if you fit within it.
Patients who are not able to understand or follow the study procedures cannot participate. This ensures that participants can safely and effectively follow the study requirements.
Patients who are pregnant or breastfeeding cannot participate. This is to protect the health of the mother and the baby.
Patients with certain medical conditions that might interfere with the study treatments cannot participate. These conditions are usually specified by the study team.
Patients who are currently participating in another clinical trial cannot participate. This is to avoid any interference between different study treatments.
Patients who have had a recent major surgery or are planning to have surgery during the study period cannot participate. This is to ensure the safety and accuracy of the study results.
Patients with known allergies to the study medications cannot participate. This is to prevent any allergic reactions during the study.

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Verified sites

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

Verified
Azienda Ospedaliera Universitaria Di Cagliari
Monserrato, Italy
Verified
Azienda Ospedaliero Universitaria Di Modena
Modena, Italy
Responsive
Istituto Oncologico Veneto
Padua, Italy

Trial locations

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Investigated drugs

Aspirin
is a medication commonly used to relieve pain, reduce inflammation, and lower fever. In this trial, it is being tested to see if it can help improve the effectiveness of chemotherapy and radiation therapy in treating rectal cancer before surgery.
Metformin
is a medication typically used to manage blood sugar levels in people with type 2 diabetes. In this trial, it is being evaluated for its potential to enhance the response of rectal cancer to chemotherapy and radiation therapy before surgery.

What is already known about the treatment

Aspirin
Aspirin is typically administered orally in tablet form. It is widely recognized in medical literature as a common medication used for pain relief, reducing inflammation, and lowering fever. In the context of this clinical trial, it is being investigated for its potential role in treating locally advanced stage II/III rectal cancer. Aspirin works by inhibiting enzymes involved in the production of substances that promote inflammation and blood clotting. It is classified as a non-steroidal anti-inflammatory drug (NSAID).
Metformin
Metformin is usually taken orally in tablet form. It is well-established in medical literature as a first-line treatment for type 2 diabetes, helping to control blood sugar levels. In this clinical trial, metformin is being explored for its potential benefits in treating locally advanced stage II/III rectal cancer. The drug functions by decreasing glucose production in the liver and improving insulin sensitivity. Metformin is classified as a biguanide.

Investigated diseases

Locally advanced stage II/III rectal cancer – This is a type of cancer that occurs in the rectum, which is the last part of the large intestine. In stage II, the cancer has grown into or through the outermost layer of the rectum but has not spread to nearby lymph nodes or distant sites. In stage III, the cancer has spread to nearby lymph nodes but not to distant parts of the body. The disease progresses as the cancer cells grow and potentially spread to other parts of the body. Symptoms may include changes in bowel habits, rectal bleeding, and abdominal discomfort. The progression can vary, and the disease may require different treatment approaches based on its stage and spread.