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RecruitingTherapeutic confirmatory (Phase III)Interventional

GASTRICHIP TRIAL. D2 resection and HIPEC (Hyperthermic IntraPeritoneal Chemoperfusion) in locally advanced gastric carcinoma. A randomized and multicentric phase III study

The GASTRICHIP trial is testing an extra treatment for adults with locally advanced stomach cancer. When people have surgery to remove stomach tumours, tiny cancer cells can sometimes remain behind in the lining of the tummy (the peritoneum). In this trial, doctors are testing a treatment called HIPEC (heated chemotherapy). During surgery, after the tumour is removed, a warm chemotherapy liquid is gently washed through the tummy cavity for a short time to kill any hidden cells. Participants are randomly placed into one of two groups: one group receives the standard surgery alone, and the other receives standard surgery plus the heated chemotherapy wash. Researchers will compare both groups over several years to see if the heated wash helps people live longer, delays cancer from returning, and protects their overall quality of life.

At a glance

Status
Recruiting
Phase
Therapeutic confirmatory (Phase III)
Sponsor
Hospices Civils De Lyon
Enrolment target
367
Start
26 Aug 2024

What is this study about?

Stomach cancer (also known as gastric cancer) is often treated with an operation to remove the tumour and nearby lymph nodes. However, even after successful surgery, there is a risk that tiny, microscopic cancer cells are left behind in the lining of the abdomen. Over time, these stray cells can grow into new tumours, making the cancer harder to treat.

To tackle this problem, researchers have developed a technique called HIPEC, which stands for Hyperthermic IntraPeritoneal Chemoperfusion. After the surgeon removes the tumour, a warm bath of chemotherapy medicine (using drugs such as oxaliplatin and fluorouracil) is circulated through the tummy for a set time before being drained away. The heat helps the chemotherapy penetrate tissues better and destroy leftover cancer cells directly, while keeping the rest of the body less exposed to the medicine.

This trial is a 'Phase 3' study, which means it is testing the treatment in a large group of patients to confirm whether it is genuinely better than standard care. Researchers want to see if HIPEC helps people live longer without their cancer returning, while also checking for any extra side effects. The results could help shape future NHS treatment guidelines for advanced stomach cancer.

Key takeaways

  • Tests whether adding heated chemotherapy during stomach surgery improves survival.
  • Aims to destroy microscopic cancer cells left behind in the tummy lining.
  • Involves adults aged 18 and older having planned stomach cancer surgery.
  • Participants are randomly chosen to have standard surgery or surgery plus the heated wash.
  • Follow-up checks and scans will track your health and quality of life over several years.

Who may be eligible?

This study is open to adults aged 18 and over who have been diagnosed with locally advanced stomach cancer (gastric adenocarcinoma) and are planned to have surgery to remove the tumour.

To take part, patients need to be well enough to cope with major surgery and chemotherapy. Doctors will review your general fitness, heart, and kidney function to ensure that having this type of operation is safe for you.

People whose cancer has already spread to distant organs (such as the liver or lungs), or those who are not fit enough for extended surgery, will generally not be able to join. Your hospital care team can confirm whether your specific stage of cancer matches the trial criteria.

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.

  1. I am aged 18 or older.
  2. I have been diagnosed with locally advanced stomach cancer (gastric adenocarcinoma).
  3. My specialist has recommended surgery to remove the tumour.
  4. My cancer has not spread widely to distant parts of the body.
  5. I am well enough to undergo major surgery and chemotherapy.
Answer every question to see your result.

What does participation involve?

If you agree to take part, you will first have standard tests, such as blood tests, scans, and physical checks, to ensure surgery is safe. You will then be randomly assigned by a computer to one of two groups. One group has standard surgery to remove the stomach tumour and surrounding lymph nodes. The other group has the same surgery followed immediately by the heated chemotherapy wash (HIPEC) while still asleep in the operating theatre.

After the operation, you will recover in hospital just as you normally would, though your stay might be slightly longer if you have the heated wash. Once you go home, you will attend regular hospital appointments for check-ups, blood tests, and scans over several years. You will also be asked to complete simple questionnaires about your daily life and how you are feeling.

Potential risks and benefits

Taking part may or may not help you directly. If the heated chemotherapy works well, it might lower the chances of your cancer coming back and help you live longer. However, HIPEC can add extra risks, such as longer surgery time, a higher chance of surgical complications, or temporary bowel problems. Standard chemotherapy side effects can also happen. You will be monitored very closely by your medical team throughout. Joining the study is completely voluntary, and you can withdraw at any time without your regular NHS care being affected.

Locations (1)

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

Common questions

Will I be awake during the heated chemotherapy wash?

No. The heated chemotherapy wash is done inside the operating theatre while you are completely asleep under general anaesthetic.

Can I choose whether I get the heated chemotherapy?

No. A computer randomly decides whether you receive surgery alone or surgery with HIPEC. This ensures the study results are fair and unbiased.

Will I still need other cancer treatments?

Yes. Most people will still receive the standard chemotherapy treatments recommended before or after surgery by their cancer specialist.

Does the heated wash make recovery more painful?

Major stomach surgery involves discomfort, but you will be given strong pain relief. Your care team will monitor you closely to manage any extra soreness or side effects.

What happens if I decide to leave the trial?

You are free to stop participating at any point. Your doctors will continue to give you the best possible standard care, and your relationship with your team will not change.

How to find out more

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

Interested in taking part?

Register your interest

Share your details and the research team for "GASTRICHIP TRIAL. D2 resection and HIPEC (Hyperthermic Intra…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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