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RecruitingPHASE2INTERVENTIONAL

Organ Preservation With Durvalumab-based Immunotherapy in Combination With Chemoradiation as Definitive Therapy for Early Stage Esophageal Adenocarcinoma With Indication for Radical Surgery

This research is investigating a new treatment approach for early oesophageal cancer that aims to help patients avoid major surgery. It combines an immunotherapy drug called durvalumab with chemotherapy (FLOT and mFOLFOX-6) and radiotherapy. The study will see if this combination can effectively shrink or completely remove the cancer, allowing for 'organ preservation' – meaning the gullet (oesophagus) can be kept. Instead of surgery, patients would have regular checks. If the cancer fully responds, they would continue with durvalumab. Surgery would only be considered if the cancer persists or returns. This trial hopes to find a safer and less invasive option for patients.

At a glance

Status
Recruiting
Phase
PHASE2
Sponsor
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
Enrolment target
32
Start
28 Aug 2023
Estimated completion
01 Dec 2028

What is this study about?

This study is a clinical trial exploring a new treatment for people with early-stage oesophageal adenocarcinoma, which is a type of cancer that starts in the gullet (oesophagus). Currently, surgery to remove part or all of the oesophagus is a common treatment, but it's a big operation.

Researchers are investigating whether a combination of treatments could be just as effective while allowing patients to avoid this major surgery. The new approach involves an immunotherapy drug called durvalumab, given alongside two types of chemotherapy (FLOT and mFOLFOX-6), and radiotherapy. Immunotherapy works by helping your own immune system fight the cancer. The main goal is to see if this combined treatment can completely get rid of the cancer, or shrink it so much that surgery isn't needed. This is called 'organ preservation' because it aims to keep your oesophagus intact.

All patients in the study will receive this combined treatment. After the treatment, doctors will perform detailed checks to see how the cancer has responded. If the cancer is gone, patients will then receive more durvalumab to help keep the cancer away, rather than having surgery. If some cancer remains, then surgery might still be offered. The study also aims to look at the patients' quality of life with this new approach.

Key takeaways

  • This study explores a new way to treat early oesophageal cancer.
  • It combines immunotherapy, chemotherapy, and radiotherapy.
  • The main goal is to help patients avoid major surgery.
  • Success means the cancer is gone, allowing the oesophagus to be kept.
  • Patients avoiding surgery will continue with regular checks and maintenance immunotherapy.
  • Surgery would still be an option if the cancer persists after initial treatment.

Who may be eligible?

To be part of this study, you need to be at least 18 years old and have been diagnosed with early-stage oesophageal adenocarcinoma. This means the cancer is either in stage T1 or T2 and hasn't spread to any nearby lymph nodes or other parts of the body (N0 M0).

Doctors will also need to confirm that your tumour was initially considered suitable for surgery. Some specific details about your tumour, including a test called PD-L1 CPS, must also be available from recent biopsies. You should also be generally well enough to take part in the study, meaning you have a good level of physical activity.

Important points that would mean you can't join include having received previous chemotherapy or radiotherapy for this cancer, or if you've already had surgery to remove your oesophageal tumour.

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. Are you 18 years old or older?
  2. Do you have early-stage oesophageal adenocarcinoma (cT1 or cT2 N0 M0)?
  3. Has your tumour been tested for PD-L1 CPS?
  4. Have you not had previous chemotherapy or radiotherapy for this cancer?
  5. Are you generally well and active enough for a clinical trial (ECOG score of 0 or 1)?
Answer every question to see your result.

What does participation involve?

If you join this study, you would first have a series of treatments. This involves receiving the immunotherapy drug durvalumab alongside two cycles of FLOT chemotherapy. After this, you would continue with durvalumab, but switch to a different chemotherapy called mFOLFOX-6, which you would have for three cycles. During this time, you would also receive radiotherapy.

After these treatments, about eight weeks later, you'll have detailed checks to see how the cancer has responded. These checks include endoscopies (where a thin tube with a camera is passed down your throat) with biopsies, internal ultrasound scans, and CT or MRI scans. If your cancer has completely gone, you would then move into a 'maintenance' phase, receiving durvalumab alone for up to 12 more cycles. Throughout the study, you'll have regular appointments to monitor your health and how you're responding to treatment.

Potential risks and benefits

Participating in a clinical trial offers the potential benefit of accessing new and promising treatments that aren't yet widely available, and helping advance medical knowledge for others. However, there are also potential risks; the combination of treatments could cause side effects, some of which might be serious. Your doctors will carefully monitor you for these. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (22)

  • Klinikum St. Marien Kommunalunternehmen - Anstalt des öffentlichen Rechts der Stadt Amberg
    Verified postcode
    Amberg, Germany· Recruiting
  • HELIOS Klinikum Bad Saarow
    Verified postcode
    Bad Saarow, Germany· Recruiting
  • Charite Univeristätsmedizin Berlin
    Verified postcode
    Berlin, Germany· Not yet recruiting
  • Universitätsklinikum Brandenburg an der Havel Medizinische Hochschule Brandenburg
    Verified postcode
    Brandenburg an der Havel, Germany· Recruiting
  • Krankenhaus St. Joseph-Stift GmbH
    Verified postcode
    Bremen, Germany· Recruiting
  • Klinikum Darmstadt GmbH
    Verified postcode
    Darmstadt, Germany· Not yet recruiting
  • Kliniken Essen Mitte Klinik für Internistische Onkologie und Hämatologie
    Verified postcode
    Essen, Germany· Recruiting
  • Institute of Clinical Cancer Research, University Cancer Center (UCT) Frankfurt Krankenhaus Nordwest
    Verified postcode
    Frankfurt, Germany· Recruiting
  • Universitätsmedizin Göttingen
    Verified postcode
    Göttingen, Germany· Recruiting
  • Universitätsklinikum Halle (Saale) Universitätsklinik und Poliklinik für Innere Medizin I
    Verified postcode
    Halle, Germany· Recruiting
  • Universitätsklinikum Heidelberg, RadioOnkologie & Strahlentherapie
    Verified postcode
    Heidelberg, Germany· Recruiting
  • St. Elisabeth Gruppe GmbH, St. Anna Hospital Herne
    Verified postcode
    Herne, Germany· Recruiting

Common questions

What is 'organ preservation'?

Organ preservation means trying to treat your cancer effectively without needing to remove your oesophagus (gullet) through surgery.

What is immunotherapy?

Immunotherapy is a type of drug treatment that works by boosting your body's own immune system to recognise and fight cancer cells.

What happens if the treatment doesn't work completely?

If detailed checks show that some cancer remains after the main treatment phase, doctors would then offer surgery as a next step.

Will I still have regular checks if I don't have surgery?

Yes, if you avoid surgery, you will have regular and thorough checks to make sure the cancer hasn't come back.

Are there different groups in this study?

Yes, but all patients receive the same core treatment. You will be placed into one of two groups based on a marker in your tumour called PD-L1 CPS.

How to find out more

Thorsten Götze, 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 "Organ Preservation With Durvalumab-based Immunotherapy in Co…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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