Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

Organ preservation in locally advanced rectal cancer by radiochemotherapy followed by consolidation chemotherapy. A prospective phase II pilot trial of the German Rectal Cancer Study Group

This study is investigating an improved treatment plan for a type of bowel cancer that has grown into nearby tissues but hasn't spread further. The main goal is to see how many people experience a complete disappearance of their cancer after a strong combination of chemotherapy and radiotherapy, followed by more chemotherapy. If this new approach works well, it could mean that some patients might not need surgery, which can have a big impact on their recovery and quality of life. The information gathered from this study will help plan a larger study to see if this treatment also helps prevent the cancer from coming back for a longer time.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Universitaetsklinikum Tuebingen AöR

Enrolment target

Start

11 Oct 2024

Male and female patients with histologically confirmed diagnosis of rectal cancer

What is this study about?

This research is looking at a new way to treat a specific type of cancer that starts in the rectum, which is the last part of your large bowel. This particular cancer is called 'locally advanced rectal cancer', meaning it has grown into nearby tissues but hasn't spread to other distant parts of the body. The usual treatment often involves surgery, but this study is exploring if some patients could be treated successfully without it.

The study combines two main types of treatment: radiotherapy, which uses strong X-rays to kill cancer cells, and chemotherapy, which uses powerful medicines. In this study, people will receive a strong course of both radiotherapy and chemotherapy first. After that, they will have even more chemotherapy. The main goal is to see if this intensified treatment can make the cancer completely disappear, so much so that it can't be seen on scans or examinations.

If the cancer completely disappears, it's called a 'clinical complete response'. Finding out how many people have this complete response is the most important part of this pilot study. The information learned here will help doctors plan bigger studies in the future. These bigger studies would then check if this treatment not only makes the cancer disappear but also stops it from coming back for at least two years. The hope is that this new approach could offer a way to treat rectal cancer effectively, potentially reducing the need for surgery for some patients.

Key takeaways

New treatment for a specific bowel cancer.
Combines strong radiotherapy and chemotherapy.
Aims for complete cancer disappearance.
Could help some patients avoid surgery.
Pilot study to gather information for future research.
Open to adults aged 18 and over.

Who may be eligible?

This study is for adults diagnosed with rectal cancer that has grown into nearby tissues. Both men and women can take part.

To be considered, your doctor would need to confirm your diagnosis through tests and make sure the cancer is a specific type called 'locally advanced rectal cancer'.

There might be other specific health requirements or conditions that mean you can or cannot join, but these would be discussed with you by the study team and your doctor. The study is open to anyone aged 18 or over.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Have you been diagnosed with rectal cancer?
Has your doctor confirmed your cancer is 'locally advanced'?
Are you willing to consider a treatment that includes both radiotherapy and chemotherapy?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will first have a number of assessments, including scans and blood tests, to make sure this treatment is right for you. You will then receive a combination of radiotherapy and chemotherapy over several weeks. Radiotherapy involves daily visits to the hospital for short treatment sessions. Chemotherapy will be given through injections or infusions (drips) and will likely involve more visits to the hospital or clinic.

After this initial treatment, you will then receive another round of chemotherapy. Throughout the study, you will have regular check-ups, blood tests, and scans to monitor how you are responding to the treatment and to keep an eye on your general health. The exact number of visits and the full duration of treatment and follow-up would be explained in detail by the study team.

Potential risks and benefits

Participating in this study might offer you a new and potentially effective treatment option for your rectal cancer, which could reduce or even remove the need for surgery. However, as with all medical treatments, there are potential risks and side effects associated with chemotherapy and radiotherapy. These can vary from person to person and will be fully explained by the study team. You always have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Germany

Common questions

What type of cancer is this study for?

This study is for 'locally advanced rectal cancer', which is a type of bowel cancer that has grown into nearby tissues.

What are the main treatments being used?

The study uses a combination of strong radiotherapy and chemotherapy, followed by more chemotherapy.

What is a 'complete response'?

A complete response means the cancer cannot be detected anymore after treatment, often checked by scans and examinations.

Could this treatment mean I don't need surgery?

That's one of the main hopes of this study – to see if some patients can avoid surgery if the treatment is very successful.

Who can join the study?

Adults (18+) who have been diagnosed with locally advanced rectal cancer can be considered for the study.