Study on Preoperative Chemoradiotherapy with Capecitabine and Temozolomide for Patients with Locally Advanced Rectal Cancer

2 1 1 1

What is this study about?

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.

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.

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.

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.

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.

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.

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.

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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Azienda Ospedaliero Universitaria Careggi	Florence	Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy

Other Sites

Site Name	City	Country
Istituto Oncologico Veneto	Padua	Italy
Pia Fondazione Di Culto E Religione Card G Panico	Tricase	Italy
Universita’ Di Pisa	Pisa	Italy
Azienda Unita Sanitaria Locale Della Romagna	Faenza	Italy
Fondazione I.R.C.C.S. Istituto Neurologico Besta	Milan	Italy

Trial status

Country	Status	Recruitment Start
Italy	Recruiting	01.09.2021

Trial locations

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.

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.

Trial ID:

2024-513931-26-00

NCT ID:

NCT05136326

Trial Phase:

Therapeutic exploratory (Phase II)

Other Trials to Consider

#1 Clinical Trials Search in Europe

Study on Preoperative Chemoradiotherapy with Capecitabine and Temozolomide for Patients with Locally Advanced Rectal Cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?