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RecruitingNAINTERVENTIONAL

Prospective Validation of Adaptive Radiotherapy (ART) in Patients With Head and Neck Tumors

This study is investigating a new type of radiation treatment for head and neck cancers called Adaptive Radiotherapy (ART). Standard radiation treatment for these cancers can sometimes cause side effects, like trouble swallowing, because healthy tissues are near the cancer. ART is a more advanced technique that uses sophisticated imaging to continually adjust the radiation plan during treatment. This means the treatment can be precisely tailored to your body each time, even if the cancer or surrounding areas shift slightly. The goal is to deliver radiation more accurately to the tumour, potentially reducing side effects and improving treatment outcomes by better protecting important organs nearby.

At a glance

Status
Recruiting
Phase
NA
Sponsor
University Hospital, Essen
Enrolment target
50
Start
15 Nov 2023
Estimated completion
15 Dec 2027

What is this study about?

This study is looking at an improved way to deliver radiation treatment, specifically for people with head and neck cancers. Radiation therapy uses high-energy rays to kill cancer cells. While this treatment is very effective, it can sometimes affect healthy tissues nearby, leading to side effects. For head and neck cancers, this might include difficulty swallowing (also known as dysphagia).

The new method being studied is called Adaptive Radiotherapy (ART). Think of it like a very smart, flexible radiation treatment. It uses special imaging technology to see how your body might change slightly from one treatment session to the next – for example, if your tongue or jaw move differently. ART allows the treatment team to adjust the radiation plan on the spot, ensuring the radiation is always aimed precisely at the cancer and avoids healthy tissues as much as possible.

The main aim of this study is to see if ART can significantly improve treatment for patients. By being able to adapt the radiation plan daily, the hope is to reduce the amount of radiation healthy organs receive, which could mean fewer side effects like swallowing problems. It also aims to understand which patients would benefit most from this advanced treatment, so it can be offered more widely in the future.

Key takeaways

  • Exploring a new, more precise radiation treatment for head and neck cancers.
  • Aims to reduce side effects by adjusting treatment daily to your exact anatomy.
  • Could improve life quality by better protecting healthy tissues.
  • Helps doctors understand who benefits most from this advanced therapy.
  • This is a study to evaluate if ART is better than current standard treatments.

Who may be eligible?

To be considered for this study, you would generally need to have a head and neck cancer that has been confirmed by a lab test. You should also be well enough to undergo radiation treatment, meaning you can generally go about your daily activities without much difficulty. The medical term for this is an ECOG score of 0 or 1.

Your doctor will need to decide if radiation is the right treatment for your specific cancer. You should also be willing and able to follow all the study's instructions and appointments. If you are pregnant, you won't be able to join this study, as it's important to protect unborn babies from radiation.

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 have been diagnosed with head and neck cancer.
  2. My cancer has been confirmed by lab tests.
  3. I am generally feeling well and can manage daily activities.
  4. My doctor believes radiation therapy is a suitable treatment for me.
  5. I am not pregnant.
Answer every question to see your result.

What does participation involve?

If you decide to participate in this study, you would receive Adaptive Radiotherapy (ART) for your head and neck cancer. This involves attending regular radiation treatment sessions, typically spread over several weeks. During each session, advanced imaging scans will be taken just before your treatment. These scans allow the medical team to see any changes in your body since your last session and adjust your treatment plan in real-time, ensuring the radiation is delivered as precisely as possible. Your medical team will monitor your progress and any side effects throughout the treatment. There will also be follow-up appointments to check how you are doing after the treatment has finished. The total duration would cover your radiation treatment course and subsequent follow-up checks.

Potential risks and benefits

Participating in this study might offer the benefit of a more precise radiation treatment, potentially reducing side effects like swallowing difficulties, compared to standard approaches. However, as with all medical treatments, there are potential risks, and this is a new approach being carefully evaluated. While ART aims to reduce side effects, some side effects related to radiation therapy may still occur. You are always free to withdraw from the study at any time, for any reason, without it affecting your usual care.

Locations (1)

  • Department for Radiotherapy, University Hospital Essen, National Center for Tumor Diseases (NCT) West
    Verified postcode
    Essen, Germany· Recruiting

Common questions

What is head and neck cancer?

Head and neck cancer is a term for cancers that develop in the mouth, throat, voice box, sinuses, or salivary glands.

What is Adaptive Radiotherapy (ART)?

ART is a type of radiation treatment that uses daily scans to adjust the radiation plan, making it more accurate and possibly safer for healthy tissues.

Will I have more scans than usual if I join this study?

Yes, you will have imaging scans each time before your radiation treatment, which helps the team adjust the plan to your body's daily changes.

What does 'protecting organs at risk' mean?

It means trying to avoid or reduce radiation exposure to healthy, important organs near the cancer, like the swallowing muscles, to prevent side effects.

Could this treatment cause new side effects?

The goal of ART is to reduce side effects, but all radiation treatments have potential risks. The study will carefully monitor any side effects you experience.

How to find out more

Maja PD Dr. med. Guberina, PD Dr. med. (MD), specialist

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 "Prospective Validation of Adaptive Radiotherapy (ART) in Pat…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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