All studies
Active not recruitingPHASE3INTERVENTIONAL

Post-operative Adjuvant Treatment for HPV-positive Tumours (PATHOS)

The PATHOS trial is investigating the best way to treat throat cancer caused by the Human Papillomavirus (HPV) after surgery. The main goal is to improve patients' ability to swallow by carefully reducing how much treatment they receive, based on the specific features of their cancer. This 'personalised' approach aims to give patients the best chance of recovery whilst also leading to fewer side effects from treatment. Researchers want to see if this less intense treatment works just as well as standard treatment in preventing the cancer from returning, focusing on whether people live just as long. They hope to improve the quality of life for those affected by this type of cancer.

At a glance

Status
Active not recruiting
Phase
PHASE3
Sponsor
Lisette Nixon
Enrolment target
1,269
Start
01 Oct 2015
Estimated completion
01 Apr 2028

What is this study about?

The PATHOS trial is a really important study for people diagnosed with a specific type of throat cancer (oropharyngeal cancer) that's linked to the Human Papillomavirus (HPV). Many people with this cancer need surgery to remove the tumour, and sometimes further treatment afterwards, like radiotherapy (strong X-rays that kill cancer cells).

The main idea behind PATHOS is to find out if we can make these follow-up treatments less intense for some patients, without reducing their chances of a full recovery. Less intense treatment could mean fewer side effects, especially problems with swallowing, which can significantly affect quality of life. The study aims to make treatment more 'personal', tailoring it to each patient based on how their cancer looks under the microscope and its HPV status. This way, doctors hope to give patients the best possible outcome – effectively treating the cancer while also protecting their ability to swallow and enjoy food.

Researchers are comparing different treatment approaches. They especially want to see if reducing the intensity of treatments still leads to patients living just as long as they would with the usual, more intense treatments. This trial builds on earlier research and includes a large number of patients across different hospitals, making the results more reliable and useful for future patient care. If successful, this trial could change how HPV-positive throat cancer is treated, leading to better quality of life for many patients.

Key takeaways

  • The PATHOS trial is for specific throat cancers linked to HPV.
  • It aims to make follow-up cancer treatment less intense after surgery.
  • The goal is to improve swallowing and reduce treatment side effects.
  • Researchers are checking if less intense treatment works just as well as standard treatment.
  • Treatment is personalised based on your cancer's unique features.
  • You'll have careful monitoring of your health and quality of life throughout the study.

Who may be eligible?

To be considered for the PATHOS trial, you would generally need to have throat cancer (specifically, oropharyngeal squamous cell carcinoma) that has been confirmed by a biopsy. Your cancer needs to be at a certain stage – not too early and not too advanced, usually T1-T3, N0-N2b. Importantly, a team of specialists (MDT) must agree that surgery to remove the tumour through the mouth, along with removing lymph nodes in the neck, is the best first step for you.

You also need to be at least 18 years old and capable of giving your full consent to join the study after understanding all the details. A crucial requirement is that your cancer must be confirmed as HPV-positive. This is checked using specific lab tests. If these tests show your cancer is HPV-negative, or if there are certain advanced features to your cancer (like it being too big for surgery through the mouth, or having spread too widely), then unfortunately you wouldn't be able to join the trial.

Additionally, if you currently smoke and have certain lymph node involvement, or if you have pre-existing severe swallowing difficulties not related to your cancer, you would also likely not be eligible. This trial focuses on a very specific group of patients where this personalised treatment approach might be most beneficial.

Quick self-check
  • Do I have HPV-positive throat cancer?
  • Has my specialist team said surgery through the mouth is my main treatment?
  • Am I generally fit enough for surgery and potentially radiotherapy?
  • Am I aged 18 or over?
  • Do I not have pre-existing severe swallowing problems?
  • Is my cancer not too advanced or spread?
  • Am I not a current smoker (with certain lymph node involvement)?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in the PATHOS trial, after giving your consent, your doctors will first confirm that your tumour is HPV-positive. Before your surgery, you'll have several assessments to check your swallowing and overall quality of life. This might involve completing questionnaires, a special X-ray called a videofluoroscopy to watch you swallow, and a simple water swallowing test. After surgery to remove your tumour and any affected lymph nodes, specialists will examine the removed tissue in detail.

Based on these detailed findings, you will be placed into one of the study groups. Some groups might receive less intense follow-up treatment (like radiotherapy), while others might not need any additional treatment. The specific follow-up treatments will be determined by the study protocol, depending on the risk factors found in your tumour. You'll continue to have regular check-ups and assessments, including those for swallowing and quality of life, throughout the study to see how well the treatments are working and how you are feeling. The overall duration of your participation, including follow-up, will be several years, as researchers need to monitor long-term outcomes like survival and cancer recurrence.

Potential risks and benefits

Participating in a clinical trial like PATHOS may offer potential benefits, such as receiving very closely monitored care from leading specialists and access to potentially new treatment approaches that aim to reduce side effects like swallowing problems. There are also potential risks involved, such as the possibility that the reduced intensity treatment might not be as effective for your specific cancer, or that you might experience side effects from any of the treatments given in the trial. It's important to remember that you are free to withdraw from the trial at any time, for any reason, without affecting your standard medical care.

Locations (57)

  • Board of Trustees of the Leland Stanford Junior University
    Redwood City, United States
  • Advent Health
    Orlando, United States
  • MD Anderson Cancer Centre
    Houston, United States
  • Metro South Health
    Brisbane, Australia
  • Unicancer
    Paris, France
  • Vivantes Klinikum
    Berlin, Germany
  • Zentrum für Hals-, Nasen- und Ohrenheilkunde
    Giessen, Germany
  • Asklepios Kliniken
    Hamburg, Germany
  • Kath Marienkrankenhaus gGmbH
    Hamburg, Germany
  • Universitaetsklinikum des Saarlandes
    Homburg, Germany
  • Universitat Leipzig
    Leipzig, Germany
  • Ernst von Bergmann Klinikum
    Potsdam, Germany

+45 more sites — see the official record for the full list.

Common questions

What is HPV-positive oropharyngeal cancer?

This is a type of throat cancer that has been caused by infection with the Human Papillomavirus (HPV). It often responds well to treatment.

What does 'adjuvant treatment' mean?

Adjuvant treatment is extra treatment given after the main treatment (like surgery) to help reduce the chance of the cancer coming back.

What is the goal of reducing treatment intensity?

The goal is to give enough treatment to cure the cancer, but not so much that it causes unnecessary side effects, especially problems with swallowing.

Will my treatment be different if I join the trial?

Yes, depending on your cancer's features, you might receive a different amount of follow-up treatment (like radiotherapy) compared to standard care, or no additional treatment at all.

How long will I be involved in the study?

Your involvement in the study will include the period around your surgery and follow-up appointments for several years to monitor your health and recovery.

How to find out more

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

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