All studies
Active not recruitingPHASE3INTERVENTIONAL

CompARE: Escalating Treatment of Intermediate and High-risk Oropharyngeal Cancer (OPC)

The CompARE trial is a research study for adults with intermediate and high-risk oropharyngeal cancer, a type of throat cancer. It's looking at different treatment approaches, specifically comparing combinations of standard radiotherapy with chemotherapy (like Cisplatin), surgery, or an immunotherapy drug called Durvalumab. The main goal is to find out if these alternative treatments can lead to better overall survival and improve patients' quality of life. This trial is in its third phase, meaning it's building on earlier research and involves many hospitals to gather robust evidence. Patients taking part will be randomly assigned to different treatment groups to ensure a fair comparison.

At a glance

Status
Active not recruiting
Phase
PHASE3
Sponsor
University of Birmingham
Enrolment target
785
Start
01 Jul 2015
Estimated completion
01 Dec 2030

What is this study about?

The CompARE study is a clinical trial focusing on oropharyngeal cancer, which is a type of cancer that affects the back of the throat, including the tonsils and the base of the tongue. This particular study is for people whose cancer is considered 'intermediate' or 'high-risk,' meaning it's more advanced or has certain features that make it harder to treat.

Researchers want to see if using a combination of treatments, such as more intensive radiotherapy, surgery, or new immunotherapy drugs like Durvalumab, can improve how long people live and their overall quality of life. Currently, standard treatment often involves radiotherapy alongside chemotherapy (drugs like Cisplatin). This trial aims to explore whether adjusting these treatments can offer better outcomes. It's a 'Phase III' trial, which means it’s comparing new approaches against the current best treatment to see if they are better.

By taking part, patients will be randomly assigned to receive one of the different treatment combinations. This 'randomisation' is important to make sure the results are fair and reliable. The study will carefully monitor patients throughout their treatment and recovery to understand the effects of each approach, both in terms of fighting the cancer and how it impacts their daily lives.

Key takeaways

  • Tests new ways to treat advanced throat cancer.
  • Compares radiotherapy, surgery, and immunotherapy.
  • Aims to improve survival and quality of life.
  • Patients are randomly assigned to treatment groups.
  • Involves regular hospital visits and monitoring.
  • Participation is voluntary; you can withdraw at any time.

Who may be eligible?

The CompARE trial is for adults between 18 and 70 years old who have been diagnosed with oropharyngeal cancer that affects the base of the tongue or tonsils. Your medical team must recommend you for treatment involving chemotherapy and radiotherapy. Generally, this trial focuses on people with more advanced cancer (referred to as T4 or N3), or those with certain types of HPV-negative cancer, or HPV-positive cancer if you have a history of significant smoking.

You would not be able to participate if your cancer is in a very early stage (T1 or T2, N0). Also, if your HPV-positive cancer is less advanced and you have a limited or no smoking history, you might not be eligible. This is because the trial is specifically looking at treatments for more challenging forms of the disease. You'll also need to be in reasonably good general health, with good kidney, liver, and blood functions, and no other cancers diagnosed in the last five years (excluding non-melanoma skin cancer or certain cervical cell changes).

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 between 18 and 70 years old?
  2. Do you have oropharyngeal cancer affecting the base of the tongue or tonsils?
  3. Has your medical team recommended you for chemotherapy and radiotherapy?
  4. Is your cancer considered more advanced (T4 or N3), or HPV-negative, or HPV-positive with a history of significant smoking?
  5. Are you generally in good health with healthy organ function?
  6. Have you not had other cancers (apart from certain skin or cervical changes) in the last 5 years?
Answer every question to see your result.

What does participation involve?

If you are eligible and choose to take part in the CompARE trial, you will be randomly assigned to one of the treatment groups. This means you might receive radiotherapy alongside chemotherapy (like Cisplatin), or you might have surgery, or you might receive an immunotherapy drug called Durvalumab, possibly in combination with other treatments. The specific plan will depend on your assigned group.

Throughout the study, you will have regular visits to the hospital for assessments, scans, and blood tests to monitor your health, how you are responding to treatment, and any side effects you might experience. These visits will be scheduled at specific times during your treatment and for a period afterwards (known as follow-up). The total duration of your participation, including follow-up, will be clearly explained by the trial team. You will be closely supported by medical staff throughout.

Potential risks and benefits

Participating in a clinical trial like CompARE might offer you access to new treatments that aren't yet widely available, and these could potentially be more effective than standard care. You will also receive very close medical attention and monitoring. However, there's no guarantee that the new treatments will be better than existing ones, and you might experience side effects, some of which could be serious or unexpected. As with any medical treatment, there are potential risks involved. It's important to remember that your participation is completely voluntary, and you have the right to withdraw from the trial at any time, for any reason, without it affecting your future medical care.

Locations (38)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • St Luke's Hospital
    Verified postcode
    Dublin, Ireland
  • St James's Hospital
    Verified postcode
    Dublin, Ireland
  • Aberdeen Royal Infirmary
    Verified postcode
    Aberdeen, United Kingdom
  • Bristol Haematology and Oncology Centre
    Verified postcode
    Bristol, United Kingdom
  • Velindre Cancer Centre
    Verified postcode
    Cardiff, United Kingdom
  • Royal Devon and Exeter Hospital
    Verified postcode
    Exeter, United Kingdom
  • Leicester Royal Infirmary
    Verified postcode
    Leicester, United Kingdom
  • Castle Hill Hospital
    Verified postcode
    Cottingham, United Kingdom
  • Western General Hospital
    Verified postcode
    Edinburgh, United Kingdom
  • Colchester General Hospital
    Verified postcode
    Colchester, United Kingdom
  • Queen's Hospital
    Verified postcode
    Romford, United Kingdom
  • Royal Preston Hospital
    Verified postcode
    Preston, United Kingdom

Common questions

What is oropharyngeal cancer?

Oropharyngeal cancer is a type of cancer that develops in the back part of the throat, including the tonsils, soft palate, and base of the tongue.

What does 'Phase III' mean for a clinical trial?

Phase III means the study is comparing a new treatment or approach against the current best standard treatment to see if it's more effective or has fewer side effects. It usually involves a larger number of patients.

What is immunotherapy?

Immunotherapy is a type of treatment that helps your body's own immune system fight cancer. Durvalumab is an example of an immunotherapy drug.

Will I get to choose my treatment?

No, if you join the trial, you will be randomly assigned to one of the treatment groups. This ensures the comparison between treatments is fair and unbiased.

Can I stop participating in the trial if I change my mind?

Yes, you can withdraw from the trial at any time, for any reason, and it will not affect your usual medical care.

How to find out more

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

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