Study on Capecitabine and Oxaliplatin for High-Risk Rectal Cancer Patients to Reduce Metastases

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What is this study about?

This clinical trial is focused on studying rectal cancer, a type of cancer that affects the last part of the large intestine. The study aims to explore the effectiveness of a treatment strategy using two medications: Capecitabine and Oxaliplatin. Capecitabine is taken orally in the form of film-coated tablets, while Oxaliplatin is administered through an intravenous infusion, which means it is given directly into a vein. These medications are part of a treatment known as CAPOX, which is a combination of chemotherapy drugs used to treat rectal cancer.

The purpose of this study is to see if using a precise approach to treatment can help control the cancer more effectively and reduce the chances of it spreading to other parts of the body. The study will involve patients who are considered to be at high risk of their cancer spreading. Participants will receive the treatment over a period of time, and their health will be monitored to assess how well the treatment is working in preventing the cancer from coming back.

Throughout the study, participants will receive regular check-ups and follow-ups to track their progress. The goal is to improve the chances of living without the cancer returning for several years after the treatment. This study is part of ongoing research to find better ways to treat rectal cancer and improve outcomes for patients.

1 initial assessment

The trial begins with an initial assessment to confirm eligibility. This includes a diagnosis of rectal adenocarcinoma and a performance status of 0-1, which indicates the ability to carry out daily activities without significant limitations.

The medical team evaluates the need for treatment with CAPOX, a combination of capecitabine and oxaliplatin, and assesses the requirement for radiation therapy (RT) or chemoradiotherapy (CRT) based on tumor characteristics.

2 treatment initiation

The treatment phase involves the administration of capecitabine and oxaliplatin. Capecitabine is taken orally in the form of film-coated tablets, while oxaliplatin is given as an intravenous infusion.

The specific dosage and frequency of administration are determined by the medical team based on individual patient needs and treatment protocols.

3 monitoring and follow-up

Throughout the trial, regular monitoring is conducted to assess the response to treatment and manage any side effects. This includes routine medical examinations and imaging studies.

The primary goal is to improve recurrence-free survival, which is evaluated at 3 and 5 years after treatment initiation.

4 completion and evaluation

Upon completion of the treatment regimen, a final evaluation is performed to determine the overall effectiveness of the therapy in reducing metastases and improving survival outcomes.

The trial is expected to conclude by December 31, 2026, with ongoing assessments to ensure long-term benefits and safety.

Who Can Join the Study?

The patient must have rectal adenocarcinoma, which is a type of cancer that starts in the cells lining the rectum.
The patient should have a WHO performance status of 0-1. This is a scale that measures how well a person can perform everyday activities, with 0 being fully active and 1 being restricted in physically strenuous activity but able to carry out light work.
The patient must be assessed by the MDT (Multidisciplinary Team) to be able to undergo CAPOX treatment, which is a combination of two chemotherapy drugs: capecitabine and oxaliplatin.
The patient must be mrEMVI+, which means there is evidence of cancer spreading into blood vessels as seen on an MRI scan.
The patient must be assessed by the MDT to require either RT (Radiotherapy) or CRT (Chemoradiotherapy) according to current standards. This is usually recommended for tumors that are T3-4 (indicating size and extent) located in the mid or low rectum, if lymph nodes are involved, if there is a threatened operative margin, or if mrEMVI is present.
The patient must be within the age range of 18 to 64 years old.
Both male and female patients are eligible to participate.
The patient should not belong to a vulnerable population, which means they should not be in a group that might need special protection or care.

Who Cannot Join the Study?

Patients with other types of cancer besides rectal cancer cannot participate.
Individuals who are not within the specified age range for the study are excluded.
Participants who are part of a vulnerable population, meaning they might need special protection or care, are not eligible.
Patients who do not meet the specific health requirements set by the study are excluded.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Pirkanmaan hyvinvointialue	Tampere	Finland
Hykzocxg Unjzvyqrns Czhajdi Hlajguab	Helsinki	Finland

Trial status

Country	Status	Recruitment Start
Finland	Not yet recruiting	01.07.2021

Trial locations

Investigated drugs:

SYNCOPE is a code name for a treatment strategy being tested in the trial. It involves using precision medicine to manage rectal cancer. The goal is to control the disease systemically, both before and after surgery, to reduce the risk of cancer spreading to other parts of the body. This approach is designed to improve the chances of patients living without the cancer coming back.

Investigated diseases:

Rectal cancer

Rectal Cancer – Rectal cancer is a type of cancer that begins in the rectum, which is the last several inches of the large intestine before the anus. It typically starts as a growth on the inner lining of the rectum, known as a polyp, which can become cancerous over time. As the disease progresses, the cancer cells can invade deeper layers of the rectal wall and potentially spread to nearby lymph nodes and other organs. The progression of rectal cancer can vary, with some cases remaining localized while others may spread to distant parts of the body. The growth and spread of the cancer can lead to symptoms such as changes in bowel habits, rectal bleeding, and abdominal discomfort. Early detection and monitoring are crucial for managing the disease effectively.

Trial ID:

2024-517149-15-00

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Capecitabine and Oxaliplatin for High-Risk Rectal Cancer Patients to Reduce Metastases

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?