Study on Organ Preservation in Advanced Rectal Cancer Patients Using Bleomycin and Electrochemotherapy After Initial Treatment

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What is this study about?

This clinical trial is focused on studying a type of cancer known as colorectal cancer, specifically targeting cases where the cancer is located in the rectum. The study is exploring a treatment approach that combines initial therapy, known as neoadjuvant treatment, with a procedure called electrochemotherapy. Electrochemotherapy involves using electrical pulses to help a drug, in this case, bleomycin, work more effectively against cancer cells.

The purpose of the study is to evaluate whether this combined treatment can safely and effectively increase the rate of complete response, meaning the cancer is no longer detectable, while also aiming to preserve the affected organ. Participants in the study will first receive the neoadjuvant treatment to shrink the tumor, followed by the electrochemotherapy procedure. The study will monitor the safety and feasibility of this approach and assess the response of the cancer to the treatment.

Throughout the study, participants will undergo various assessments to ensure their safety and to evaluate the effectiveness of the treatment. The ultimate goal is to determine if this method can improve outcomes for patients with locally advanced rectal cancer, potentially offering a way to treat the cancer while preserving the function of the rectum.

1 joining the study

Participation begins after meeting specific criteria, including age, diagnosis, and treatment history.

Eligibility requires a confirmed diagnosis of rectal adenocarcinoma and a significant response to prior treatment.

2 initial assessment

An initial assessment is conducted to evaluate the current status of the rectal tumor.

This assessment includes a review of medical history and physical examination.

3 neoadjuvant treatment

Patients undergo neoadjuvant treatment, which is therapy given before the main treatment to shrink the tumor.

The goal is to achieve a major clinical response, making the tumor more manageable.

4 electrochemotherapy

Following neoadjuvant treatment, electrochemotherapy is administered.

This involves the use of bleomycin, a medication given through intravenous use.

The procedure aims to enhance the response rate and facilitate organ sparing.

5 evaluation of response

The response to treatment is evaluated through histopathological analysis.

This involves examining tissue samples to assess the extent of tumor response.

6 follow-up

Regular follow-up appointments are scheduled to monitor health and treatment outcomes.

These appointments help ensure the safety and effectiveness of the treatment.

Who Can Join the Study?

Male or female patients aged 18 years or older.
Must have a histological confirmation of rectal adenocarcinoma, which means a tissue sample has been examined under a microscope to confirm the type of cancer.
Patients should be undergoing neoadjuvant treatment for a locally advanced tumor of the rectum. This is treatment given before the main treatment to shrink the tumor.
Must have a confirmed major clinical response after neoadjuvant treatment, meaning the tumor has responded well to the initial treatment.
The rectal tumor should be located up to 12 cm from the external anal margin.
Patients must be willing to follow the study protocol and provide their informed written consent, which means they agree to participate after understanding the study details.
Patients should have an ECOG status performance of less than 3. This is a scale used to assess how a patient’s disease is affecting their daily living abilities, with lower numbers indicating better functioning.

Who Cannot Join the Study?

Patients who are not diagnosed with colorectal cancer cannot participate. Colorectal cancer is a type of cancer that affects the colon or rectum, which are parts of the large intestine.
Individuals who are not within the specified age range for the study cannot participate. The study includes certain age groups, so if you are outside these groups, you may not be eligible.
Both males and females are eligible, so gender is not a reason for exclusion.
Individuals who are considered part of a vulnerable population are not included. A vulnerable population might include people who are unable to give informed consent or who are at a higher risk of harm.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Policlinico “Tor Vergata”, Università degli Studi di Roma TOR VERGATA	Rome	Italy

Other Sites

Site Name	City	Country
IRCCS Istituto Nazionale Tumori Fondazione Pascale	Naples	Italy
Azienda Sanitaria Locale Della Provincia Di Barletta Andria Trani	Andria	Italy
A.O.U. Policlinico G. Martino Di Messina	Messina	Italy
Azienda Ospedaliera Universitaria Di Cagliari	Monserrato	Italy
Agtzycw Uhry ndy Suarlbxqzmi – Oripibcr dz Mrjpoi	Mirano	Italy
Agmwejn Uqlac Scjanymki Lpexqq Do Baosnjd	Bologna	Italy

Trial status

Country	Status	Recruitment Start
Italy	Not yet recruiting	01.01.2019

Trial locations

Investigated drugs:

Bleomycin

Electrochemotherapy is a treatment that combines chemotherapy with electrical pulses. The electrical pulses help the chemotherapy drugs enter cancer cells more effectively. This therapy is being studied for its potential to treat locally advanced rectal cancer by increasing the complete response rate, which means reducing or eliminating the cancer without needing to remove the organ.

Investigated diseases:

Rectal cancer

Colorectal Cancer – Colorectal cancer is a type of cancer that starts in the colon or rectum, which are parts of the large intestine. It often begins as small, noncancerous clumps of cells called polyps that form on the inside of the colon or rectum. Over time, some of these polyps can become cancerous. The progression of the disease can lead to symptoms such as changes in bowel habits, blood in the stool, and abdominal discomfort. As the cancer advances, it may spread to other parts of the body. Early detection and removal of polyps can prevent the development of colorectal cancer.

Trial ID:

2024-519050-37-00

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Organ Preservation in Advanced Rectal Cancer Patients Using Bleomycin and Electrochemotherapy After Initial Treatment

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?