RecruitingOBSERVATIONAL

Response Prediction of Hyperthermic Intraperitoneal Chemotherapy in Gastro- Intestinal Cancer

This study is for people with stomach or bowel cancer that has spread to the lining of the tummy (peritoneal carcinomatosis). During your planned surgery, doctors will take a small piece of your tumour. This tiny piece is then carefully grown in the lab to create what scientists call 'organoids' – like mini versions of your tumour. Researchers will test different chemotherapy drugs on these lab-grown tumour pieces to see which ones are most effective. They will also look closely at the tumour's genetic makeup to find specific changes that might respond to targeted medicines. The aim is to better predict which treatments will work best for individual patients, helping to guide future, more personalised treatment plans.

At a glance

Status

Recruiting

Sponsor

Technische Universität Dresden

Enrolment target

Start

08 Dec 2022

Estimated completion

31 Dec 2028

Gastric Cancer Colon Cancer Peritoneal Carcinomatosis

What is this study about?

This research study is designed for individuals who have stomach or bowel (colon) cancer that has spread to the lining of the belly, a condition known as peritoneal carcinomatosis. Standard treatment for this often involves surgery to remove the main tumour and any visible spread, followed by a special type of chemotherapy called HIPEC (hyperthermic intraperitoneal chemotherapy). This is where warm chemotherapy drugs are circulated directly within the tummy cavity.

The main idea of this study is to help doctors understand which treatments are most likely to work for each patient. During your planned surgery, doctors will take a very small sample of your tumour. This sample is then sent to a research lab where scientists are able to grow tiny, 3D models of your tumour, often called 'organoids'. Think of them as miniature versions of your tumour that can be studied outside your body.

In the lab, a variety of chemotherapy drugs and other targeted medicines will be tested on these tumour organoids. The researchers will observe how the organoids react to each treatment. They will also examine the organoids' genetic information very closely to identify any unique features or changes in the cancer cells. By doing this, they hope to find certain alterations that could be targeted by specific medications. The ultimate goal is to find better ways to predict which treatments will be most effective for you, leading to more tailored and successful treatment plans in the future.

Key takeaways

This study helps understand stomach/bowel cancer spread to the tummy lining.
Small tumour samples are taken during your regular surgery.
Scientists grow 'mini-tumours' in the lab to test different drugs.
The goal is to find better, more personalised treatments for the future.
Your surgery and treatment won't change if you join this research.

Who may be eligible?

This study is looking for people who have stomach or bowel cancer that has spread to the lining of their tummy (peritoneal carcinomatosis). This spread can be discovered either at the same time as your main cancer diagnosis, or later on.

To be considered, your doctors must believe that the cancer spread in your tummy can be largely or completely removed by surgery. You also need to be well enough for surgery and for the HIPEC treatment, with a life expectancy of at least six months. You must be 18 years or older and able to understand and agree to take part in the study.

However, you won't be able to join if your cancer has spread to other areas of the body that cannot be removed by surgery (like extensive spread in the liver or lungs), or if you've already had many treatments for this type of spread. Other reasons may include serious heart problems, being pregnant or breastfeeding, or having certain other medical conditions.

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.

Do I have stomach or bowel cancer that has spread to the lining of my belly?
Am I planned for surgery to remove this cancer spread?
Am I well enough for surgery and also for the HIPEC treatment?
Am I 18 years or older?
Have I not had extensive cancer spread to other organs like the liver or lungs?
Am I not pregnant or breastfeeding?

Answer every question to see your result.

What does participation involve?

If you join this study, the main part of your participation happens during your planned surgery for stomach or bowel cancer and its spread. During this operation, your surgeon will take a small piece of your tumour for the research. This is done as part of the standard procedure and won't require extra surgery or change your surgical plan.

There are no extra hospital visits or follow-up appointments specifically for this research beyond your usual medical care. You won't receive extra medication from the study itself. The research team will be studying your tumour sample in the lab, and you won't be directly involved in that part. The total duration of your direct participation is essentially the time of your surgery when the tissue sample is taken.

Potential risks and benefits

There are no direct medical benefits to you from taking part in this study, as the findings from your tumour sample will help guide future treatments for others and potentially for you if needed later. The main benefit is contributing to scientific knowledge that could lead to better, more personalised treatments for stomach and bowel cancer in the future. The risks related to the study are minimal, as the tissue sample is taken during your already planned surgery and does not change the surgery or HIPEC procedure itself. As with any study, you have the right to withdraw your consent at any time without affecting your medical care.

Locations (2)

Department of Visceral, Thoracic and Vascular Surgery, University Hospital Carl Gustv Carus Dresden
Verified postcode
Dresden, Germany· Recruiting
University Hospital Heidelberg
Verified postcode
Heidelberg, Germany· Not yet recruiting

Common questions

What is peritoneal carcinomatosis?

It's when cancer, in this case from the stomach or bowel, spreads to the lining of your tummy (abdomen).

What are 'organoids'?

They are tiny, lab-grown versions of your tumour cells that help scientists test treatments outside your body.

Will I get different surgery if I join?

No, your surgery and HIPEC treatment will be the same as planned. The study just takes a small extra tissue sample during the operation.

Will this study help me directly?

The information from your sample might help guide your future treatments, but the main goal is to improve understanding and treatments for everyone with this cancer.

Is the HIPEC treatment part of the study?

HIPEC is a standard treatment for this condition. This study is researching the tumour samples taken during the surgery that includes HIPEC.

How to find out more

Daniel Stange, Prof. Dr.

daniel.stange@ukdd.de +49 351 458 4098 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.