Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

Neoadjuvant Chemotherapy followed by Pre-operative Chemoradiation and Consolidation Chemotherapy before Surgery in High Risk Rectal Cancer: Multicentric Phase II Study

This study is looking into a new treatment approach for a type of bowel cancer called 'high-risk rectal cancer'. This means the cancer is more serious or has a higher chance of coming back. The treatment involves giving strong cancer medicines (chemotherapy and chemoradiation) in stages before surgery. The aim is to shrink the tumour as much as possible, or even make it disappear completely, before it's removed. Researchers want to see if this combination of treatments, given in a specific order, can lead to all cancer cells being gone when the removed tissue is examined. This could mean better outcomes for patients and improve our understanding of how best to treat this type of cancer. It's a Phase II study, meaning it's exploring how well this new treatment pathway works.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Centro Di Riferimento Oncologico Di Aviano

Enrolment target

Start

30 Sep 2024

High Risk Rectal Cancer

What is this study about?

This study is looking at a new way to treat a type of bowel cancer called 'high-risk rectal cancer'. This means the cancer is quite serious, perhaps because of its size, how deeply it has grown, or if it has spread to nearby lymph nodes. Currently, standard treatment often involves surgery, chemotherapy, and radiotherapy.

In this study, doctors are trying a new sequence of treatments. First, patients will receive some chemotherapy (strong medicines to kill cancer cells). Then, they will have chemoradiation, which is a combination of chemotherapy and radiotherapy working together. After this, there will be more chemotherapy before surgery to remove the tumour. The main goal is to see if giving these treatments in this specific order can make the cancer completely disappear before surgery, which doctors call a 'pathological complete remission'.

This is important because if the cancer completely disappears before surgery, it might lead to better long-term results for patients. By carefully studying this new approach, doctors hope to find more effective ways to treat high-risk rectal cancer and improve the chances of a successful outcome for people affected by this condition. It's a Phase II study, which means it's an important step in exploring how well this specific treatment plan works and if it's safe for patients.

Key takeaways

This study explores a new sequence of treatments for high-risk rectal cancer.
It combines different powerful cancer medicines and radiation before surgery.
The main aim is to see if the cancer can completely disappear before surgery.
The study is for adults diagnosed with high-risk rectal cancer.
Participation involves multiple hospital visits, treatments, and monitoring.
It's a Phase II study, exploring how well this new treatment works.

Who may be eligible?

To join this study, you need to be an adult, 18 years old or older. There is no upper age limit, meaning older adults can also be considered.

This study is for both men and women. You would need to have been diagnosed with 'high-risk rectal cancer'. This is a specific type of bowel cancer that doctors have determined is more serious or has a higher chance of needing intensive treatment.

The research team will carry out several checks and tests to make sure that taking part in this study is right for you and safe. This will involve reviewing your medical history and current health.

Quick self-check

Are you 18 years old or older?
Have you been diagnosed with 'high-risk rectal cancer'?
Are you generally well enough to undergo chemotherapy and radiation?
Are you comfortable with the idea of a combination of treatments before surgery?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, you'll first have several hospital visits for tests to see if you're suitable. Once enrolled, you'll receive chemotherapy medicines like capecitabine and oxaliplatin, usually given in cycles over several weeks. These might be given as tablets or through a drip into your arm. You'll also have a period of chemoradiation, which involves daily radiation treatments combined with chemotherapy.

There will be regular doctor appointments, blood tests, and scans (like MRI or CT) to monitor how you're responding to the treatment and to check for any side effects. After all treatments are completed, you will have surgery to remove the tumour. Following surgery, you'll continue to have follow-up appointments and tests for a period of time to see how you're recovering and to check for any signs of the cancer returning. The total duration of active treatment and follow-up will be explained in detail by the study team.

Potential risks and benefits

Taking part in a study like this could mean you receive a new treatment approach that might be more effective than standard treatments, potentially leading to better outcomes for your cancer. However, all medical treatments, especially chemotherapy and radiotherapy, carry risks. You might experience side effects like feeling sick, tiredness, hair loss, or skin irritation, and there could be more serious, though rare, side effects that the study team will discuss with you. There's no guarantee the treatment will work for everyone, and it might not improve your condition. You have the right to withdraw from the study at any time, for any reason, without affecting your future medical care.

Locations (1)

—
Italy

Common questions

What is 'high-risk rectal cancer'?

It's a type of bowel cancer where the tumour is located in the rectum and has certain features that make it more serious or likely to need intensive treatment, like being large or spread to nearby areas.

What do 'chemotherapy' and 'chemoradiation' mean?

Chemotherapy uses strong medicines to kill cancer cells throughout your body. Chemoradiation combines chemotherapy with radiation therapy, which uses high-energy rays to shrink or kill cancer cells in a specific area.

What is the main goal of this study?

The main goal is to see if giving chemotherapy, then chemoradiation, then more chemotherapy before surgery can make the cancer completely disappear before the operation.

Will I still need surgery if the cancer disappears?

Yes, in this study, surgery is planned after the other treatments, even if the cancer appears to have completely gone, to ensure all affected tissue is removed.

What are CAPECITABINE and OXALIPLATIN?

These are names of specific chemotherapy drugs that are commonly used to treat bowel cancer. They work by stopping cancer cells from growing and dividing.