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Not yet recruitingPHASE3INTERVENTIONAL

Adjuvant Trial in Patients With Resected PDAC Randomized to Allocation of Oxaliplatin- or Gemcitabine-based Chemotherapy by Standard Clinical Criteria or by a Transcriptomic Treatment Specific Stratification Signature

This important UK study, called ESPAC-6, is for people who have had surgery for pancreatic cancer. After surgery, chemotherapy is often given to prevent the cancer from coming back. This trial wants to find out if using a special genetic test to choose the right chemotherapy for each patient is better than the usual way doctors decide. The study will compare two main types of chemotherapy – oxaliplatin-based or gemcitabine-based – to see which approach leads to longer periods without the cancer returning. The goal is to improve how we treat pancreatic cancer after surgery, making choices more personalised and effective for every patient.

At a glance

Status
Not yet recruiting
Phase
PHASE3
Sponsor
John Neoptolemos
Enrolment target
394
Start
15 Jan 2025
Estimated completion
01 Sep 2031

What is this study about?

This study, called ESPAC-6, is for people who have recently had surgery to remove pancreatic cancer. After this type of surgery, doctors often recommend chemotherapy to reduce the chance of the cancer coming back. Currently, doctors decide which chemotherapy to give based on standard information.

This trial is investigating a new idea. Researchers want to see if using a special genetic test, which looks at the cancer's unique features, can help choose a more effective chemotherapy for each individual. They will compare patients who receive chemotherapy chosen by this new genetic test with patients whose chemotherapy is chosen in the usual way. The main aim is to find out if this personalised approach leads to the cancer staying away for longer.

Beyond just choosing treatment, this study also aims to learn more about pancreatic cancer. Researchers will collect samples to understand why some treatments work better for certain people and why cancer might come back. This will help doctors in the future to develop even more targeted and effective treatments for pancreatic cancer patients.

Key takeaways

  • A UK study for pancreatic cancer patients after surgery.
  • Compares standard chemotherapy choice with a new genetic test approach.
  • Aims to find the best way to prevent cancer from returning.
  • Involves standard chemotherapy drugs like Oxaliplatin or Gemcitabine.
  • Might lead to more personalised treatment in the future.
  • Participation includes regular hospital visits and follow-up.

Who may be eligible?

This study is looking for both men and women between the ages of 18 and 79 who have been diagnosed with pancreatic cancer that has been successfully removed by surgery. It's important that your general health is good enough to receive chemotherapy, meaning you can eat well, aren't suffering from severe nausea, and your blood test results (like your blood counts and kidney function) are in a healthy range.

You wouldn't be able to join if your cancer had spread to distant parts of your body, or if the surgeon hadn't been able to remove all of the cancer visible during the operation. Also, if you've already had chemotherapy or radiotherapy for your pancreatic cancer, this study wouldn't be suitable for you. You also need to have recovered well from your surgery and be ready to start chemotherapy within 3 to 12 weeks after your operation.

If you're a woman who could become pregnant, you'd need to use effective contraception throughout the study and for 6 months afterwards. Men would also need to use contraception for 6 months after their last treatment. It's really important that you understand what's involved in the study and are willing to give your written permission to take part.

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. Have I had surgery for pancreatic cancer where all visible cancer was removed?
  2. Am I between 18 and 79 years old?
  3. Am I generally well, recovering from surgery, and able to receive chemotherapy?
  4. Have I not had chemotherapy or radiotherapy for pancreatic cancer before?
  5. Do I understand what's involved and agree to take part?
  6. If female and able to become pregnant, am I willing to use effective contraception during the study?
Answer every question to see your result.

What does participation involve?

If you join this study, your journey will begin after your pancreatic cancer surgery, usually within 3 to 12 weeks. You'll be assigned by chance to one of two groups: either your chemotherapy will be chosen using standard medical guidelines, or it will be chosen based on a special genetic test of your tumour. Both groups will receive a standard chemotherapy regimen, either oxaliplatin-based (like FOLFOX or FOFLIRI) or gemcitabine-based (like Gemcitabine alone or with Capecitabine).

You will have regular hospital visits to receive your chemotherapy treatments and for check-ups and monitoring your health. These visits will typically involve blood tests and physical examinations. The total duration of your active chemotherapy treatment will depend on the specific regimen you receive, but you will be followed up for several years after completing treatment to see how you are doing, usually with scans and check-ups. You might also be asked to provide additional tumour tissue and blood samples for research purposes at specific times.

Potential risks and benefits

Taking part in any clinical trial has potential benefits and risks. A potential benefit of this study is that you might receive personalised chemotherapy chosen specifically for your cancer based on genetic information, which could potentially improve your outcome. However, there's no guarantee it will be more effective than standard treatment. All chemotherapy treatments carry risks of side effects, such as nausea, tiredness, and hair loss, which your medical team will discuss with you. You are completely free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (33)

  • Universitätsklinikum Aachen, Studienzentrum Viszeralmedizin Klinik für Allgemeine-, Viszeral und Transplatationschirurgie
    Verified postcode
    Aachen, Germany
  • Universitätsklinikum Augsburg, III. medizinische Klinik
    Verified postcode
    Augsburg, Germany
  • St. Josef-Hospital, Klinikum der Ruhr-Universität Bochum, Abteilung für Hämatologie, Onkologie und Palliativmedizin, Studienambulanz
    Verified postcode
    Bochum, Germany
  • Universitätsklinikum Bonn, Chirurgische Abteilung
    Verified postcode
    Bonn, Germany
  • DIK Deggendorf, Onkologische Ambulanz
    Verified postcode
    Deggendorf, Germany
  • Universitätsklinikum Carl Gustav Carus an der TU Dresden, Klinik und Poliklinik für Viszeral-, Thorax- und Gefäßchirurgie
    Verified postcode
    Dresden, Germany
  • Universitätsklinikum Erlangen, Chirurgische Klinik Zentrum für klinische Studien
    Verified postcode
    Erlangen, Germany
  • Universitätsklinikum Frankfurt, Klinik für Allgemein-, Viszeral- und Transplantationschirurgie,
    Verified postcode
    Frankfurt, Germany
  • Universitätsklinikum Freiburg, Klinik für Allgemein und Viszeralchirurgie, Abteilung Chirurgie
    Verified postcode
    Freiburg im Breisgau, Germany
  • Universitätsklinikum Halle (Saale), Klinik und Poliklinik für Innere Medizin I
    Verified postcode
    Halle, Germany
  • Universitätsklinikum Hamburg Eppendort, Zentrum für operative Medizin, Klinik und Poliklinik für Allgemein-, Viszeral- und Thoraxchirurgie
    Verified postcode
    Hamburg, Germany
  • Medizinische Hochschule Hannover, Klinik für Gastroenterologie, Hepatologie und Endokrinologie
    Verified postcode
    Hanover, Germany

Common questions

What is the main goal of this study?

To see if choosing chemotherapy based on a special genetic test helps prevent pancreatic cancer from returning after surgery, compared to standard methods.

What kind of treatments are involved?

The study uses standard chemotherapy treatments, either oxaliplatin-based or gemcitabine-based, but how they are chosen is different.

Who can take part?

Adults aged 18-79 who have had successful surgery for pancreatic cancer and are generally well enough for chemotherapy.

Will I know which treatment group I'm in?

Yes, this is an 'open-label' study, meaning you and your doctor will know which method was used to pick your chemotherapy.

What happens after my chemotherapy?

You will have regular follow-up appointments and scans for several years to monitor your health and see if the cancer returns.

How to find out more

John Neoptolemos, Prof. Dr.

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 "Adjuvant Trial in Patients With Resected PDAC Randomized to …" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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