Preoperative intraperitoneal chemotherapy in adjuvant hyperthermia adjunctive therapy in advanced gastric cancer with high-risk of peritoneal recurrence - a multicentre randomized trial.
This research study is for people with advanced stomach cancer where there's a high risk of the cancer returning in the lining of the tummy, known as peritoneal recurrence. Doctors are investigating if giving a chemotherapy drug called Irinotecan directly into the tummy during surgery can prevent the cancer from coming back. This is an integrated Phase II and Phase III study, meaning it's testing if the treatment is safe and effective, and then comparing it to standard care. The main goals are to see how well this treatment stops the cancer from returning, measure how long people live without the cancer coming back, and understand how it affects their quality of life. Participants will be carefully monitored, and their wellbeing will be assessed using special questionnaires. The study aims to find better ways to treat stomach cancer and improve life for patients.
At a glance
What is this study about?
This clinical trial is designed for people who have advanced stomach cancer, particularly when there's a significant concern that the cancer might come back in the lining of the abdomen, which doctors call peritoneal recurrence. When cancer spreads to this area, it can be challenging to treat, and preventing it is a major goal for doctors.
The study is testing a specific type of treatment called intraperitoneal chemotherapy with a drug called Irinotecan. 'Intraperitoneal' simply means the chemotherapy drug is put directly into the tummy cavity during surgery. The idea behind this is to deliver the powerful cancer-fighting drugs directly to where the cancer cells might be, hopefully killing them off and stopping the cancer from returning in that area.
Researchers are keen to find out if this approach helps to reduce the chances of the cancer coming back, not just in the tummy lining, but overall. They are also very interested in how this treatment affects a person's daily life and general wellbeing. They will use special questionnaires to understand any changes to quality of life during and after the treatment. This is important because the aim of any treatment is not just to extend life, but also to ensure a good quality of life.
Key takeaways
- Tests a new chemotherapy method for advanced stomach cancer.
- Aims to prevent cancer returning in the tummy area.
- Looks at how treatment affects quality of life.
- Uses a drug called Irinotecan, given during surgery.
- Suitable for adults aged 18 and over.
Who may be eligible?
This study is looking for adults who are at least 18 years old. There's no upper age limit, meaning older adults can also take part if they meet other criteria. Both men and women are welcome to join this research.
To be considered for this study, you must have advanced stomach cancer where your doctors believe there's a high chance of the cancer returning in the lining of your tummy after surgery. Your doctors will need to review your specific situation and medical history to make sure this study is right for you and that you meet all the necessary health requirements.
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 advanced stomach cancer?
- Have your doctors said there's a high chance of your cancer returning in the tummy lining?
- Are you able to undergo surgery for your stomach cancer?
- Are you generally well enough to take part in a clinical trial?
What does participation involve?
If you join this study, you would receive the treatment during your stomach cancer surgery. Afterward, you would have regular check-ups with the study team. These check-ups will include physical examinations, blood tests, and scans to monitor your health and see how well the treatment is working. You will also be asked to fill in questionnaires about your quality of life, which are important for understanding how the treatment affects your daily living. The exact number of visits and the total duration of your participation would be explained in detail by the study team, but typically, follow-up for cancer studies can last for several years to track long-term outcomes.
Potential risks and benefits
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Common questions
What is advanced gastric cancer?
Advanced gastric cancer is stomach cancer that has grown or spread beyond the stomach itself, which can make it more challenging to treat.
What does 'peritoneal recurrence' mean?
Peritoneal recurrence means that the cancer has come back in the lining of your tummy (abdomen) after initial treatment.
What is Irinotecan?
Irinotecan is a chemotherapy drug commonly used to treat various types of cancer. In this study, it's given directly into the tummy.
What does 'quality of life assessment' involve?
This involves filling out questionnaires about your physical well-being, emotional state, and how the treatment affects your daily activities and symptoms.
Can I still receive my usual care if I join?
This study is an additional treatment given during surgery. Your other standard treatments and care will be managed by your medical team in conjunction with your participation in the study.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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