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Study on Preoperative Chemoradiotherapy with Capecitabine and Temozolomide 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 a type of cancer called locally advanced rectal cancer. The study is investigating the effects of a treatment that combines two medications: capecitabine and temozolomide. These medications are used as part of a treatment approach called chemoradiotherapy, which combines chemotherapy and radiation therapy to treat cancer. The purpose of the study is to evaluate how effective this combination is in treating patients with a specific type of rectal cancer that has certain genetic characteristics, such as being MGMT silenced and microsatellite stable.

Participants in the study will receive the medications capecitabine and temozolomide before undergoing surgery to remove the cancer. The study will monitor how well the cancer responds to the treatment and whether the cancer can be completely removed during surgery. The study will also look at other outcomes, such as the rate of successful surgeries without cancer cells left behind, the ability to preserve the anal sphincter, and the chances of the cancer returning after treatment.

The trial will take place over several years, with participants being closely monitored throughout the process. The study aims to provide valuable information on the effectiveness of this treatment combination for patients with this specific type of rectal cancer, potentially leading to improved treatment options in the future.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, the patient will begin the process of preoperative chemoradiotherapy. This involves the use of medications and radiation therapy to treat locally advanced rectal cancer.
Step 2
Medication administration
The patient will receive two medications: temozolomide and capecitabine. Both medications are taken orally.
The specific dosage and frequency of these medications will be determined by the healthcare provider based on individual patient needs and study protocols.
Step 3
Chemoradiotherapy
The patient will undergo chemoradiotherapy, which combines chemotherapy with radiation therapy. This treatment aims to shrink the tumor before surgery.
The duration of this treatment phase will be specified by the healthcare provider, following the study's guidelines.
Step 4
Surgical evaluation
After completing chemoradiotherapy, the patient will be evaluated for surgery. The goal is to determine if the tumor can be surgically removed.
The evaluation will include various tests and imaging studies to assess the tumor's response to treatment.
Step 5
Surgery
If the tumor is deemed resectable, the patient will undergo surgery to remove the tumor. The type of surgery will depend on the tumor's location and size.
The surgery aims to achieve a complete removal of the tumor with clear margins, meaning no cancer cells are left at the edges of the removed tissue.
Step 6
Post-surgery follow-up
Following surgery, the patient will have regular follow-up appointments to monitor recovery and check for any signs of cancer recurrence.
These follow-ups will include physical exams, imaging tests, and possibly additional treatments if necessary.
Step 7
Study completion
The study is expected to conclude by September 2026. The patient's participation will continue until the study's end or until the healthcare provider determines it is appropriate to conclude participation.
Throughout the study, the patient's health and response to treatment will be closely monitored to ensure safety and effectiveness.

Who can join the trial?

18 criteria

Provide written informed consent to participate in the study.
No enlarged lymph nodes in the pelvic area that are larger than 1 cm.
No signs of cancer spreading into blood vessels outside the rectum.
No signs of cancer spreading to other parts of the body, confirmed by CT scans and PET/CT scans.
No signs of cancer affecting the pelvic side walls, as shown by imaging tests.
The tumor must be able to be completely removed through surgery.
No previous invasive tumors in the rectum.
Blood health: enough white blood cells, platelets, and hemoglobin levels.
Liver health: normal levels of bilirubin, alkaline phosphatase, AST, and ALT.
Kidney health: normal creatinine levels or creatinine clearance.
Must be 18 years or older.
General health status: ECOG PS score of 0-1, which means fully active or restricted in physically strenuous activity but able to carry out light work.
Expected to live at least 5 more years, not considering the cancer diagnosis.
Confirmed diagnosis of rectal adenocarcinoma with specific molecular characteristics.
The cancer is locally advanced but can be surgically removed.
The tumor is located less than 15 cm from the anal verge.
Specific cancer stages: cT3N0 or cT1-3N1, meaning certain tumor and lymph node sizes.
Less than four lymph nodes in the mesorectum showing signs of cancer on MRI.

Who cannot join the trial?

7 criteria

Patients with any other type of cancer besides locally advanced rectal cancer (LARC) cannot participate. LARC is a type of cancer that affects the rectum, which is the last part of the large intestine.
Patients who do not have microsatellite stability are excluded. This means the cancer cells do not have a specific genetic feature that is stable.
Patients who are not MGMT negative IHC cannot join. This refers to a test that shows if a certain protein, MGMT, is not present in the cancer cells.
Patients without MGMT promoter methylation are excluded. This means a specific part of the DNA, called the MGMT promoter, must have a chemical change known as methylation.
Patients who are not within the specified age range cannot participate. The age range includes adults and older adults.
Both male and female patients are eligible, but those who do not meet other criteria are excluded.
Patients who are considered part of a vulnerable population are not allowed to participate. This means people who might need special protection or care.

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Verified sites

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

Responsive
Azienda Ospedaliero Universitaria Careggi
Florence, Italy
Verified
Azienda Unita Sanitaria Locale Della Romagna
Faenza, Italy
Responsive
Istituto Oncologico Veneto
Padua, Italy

Trial locations

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Investigated drugs

Capecitabine
is a medication used in this trial as part of the standard chemoradiation treatment. It is a type of chemotherapy that works by interfering with the growth of cancer cells, slowing their spread in the body. In this study, it is used to help shrink the tumor before surgery.
Temozolomide
is an additional medication being tested in this trial. It is also a type of chemotherapy that damages the DNA of cancer cells, which can lead to their death. The trial is investigating whether adding temozolomide to the standard treatment with capecitabine can improve the response to therapy in patients with a specific type of rectal cancer.

What is already known about the treatment

Capecitabine
Capecitabine is administered orally in the form of tablets. It is currently used in medical practice and literature as a chemotherapy drug. The main therapeutic indication for capecitabine is the treatment of various cancers, including rectal cancer. It works by interfering with the DNA synthesis of cancer cells, inhibiting their growth and division. Capecitabine is classified as an antimetabolite in pharmacology.
Temozolomide
Temozolomide is administered orally in capsule form. It is recognized in medical literature as a chemotherapy agent. The primary therapeutic use of temozolomide is in the treatment of certain types of brain tumors, but it is also being studied for use in rectal cancer. It functions by damaging the DNA of cancer cells, preventing their replication. Temozolomide is classified as an alkylating agent in pharmacological terms.

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 lymph nodes but not to distant body parts. It often presents with symptoms such as changes in bowel habits, rectal bleeding, and abdominal discomfort. The progression involves the tumor potentially invading surrounding tissues and organs, which can complicate surgical removal. Treatment typically aims to shrink the tumor before surgery to increase the chances of complete removal and preserve normal function. The disease is characterized by its potential to recur locally if not fully eradicated.