RecruitingPHASE2INTERVENTIONAL

Neoadjuvant Chemotherapy and Transoral Robotic Surgery for Oropharyngeal Cancer.

This study is investigating a different treatment approach for a type of throat cancer linked to HPV. Currently, this cancer is often treated with a combination of chemotherapy and radiotherapy. While effective, radiotherapy can cause lasting side effects like swallowing problems and dry mouth, which can affect a patient's quality of life. This new approach involves chemotherapy given upfront, followed by a type of keyhole robotic surgery to remove the tumour and nearby lymph nodes. Researchers hope this method will be just as good at curing the cancer but with fewer and less severe long-term side effects, potentially avoiding radiotherapy for many patients and improving their recovery and daily life.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Nader Sadeghi

Enrolment target

Start

14 Aug 2018

Estimated completion

30 Aug 2026

Oropharynx Cancer Tonsil Cancer Throat Cancer Base of the Tongue Carcinoma

What is this study about?

This study is looking into a new way to treat a specific type of throat cancer called oropharyngeal cancer. This cancer often affects areas like the tonsils and the back of the tongue, and it's frequently linked to the human papillomavirus (HPV). You might hear it referred to as tonsil cancer or base of the tongue cancer. We know that current treatments, which often involve chemotherapy combined with radiotherapy, are effective at treating the cancer. However, these treatments, especially radiotherapy, can unfortunately lead to some tough and long-lasting side effects.

Many patients who undergo traditional treatment experience issues like difficulty swallowing, changes in their taste, and a very dry mouth. These problems can significantly impact their daily life for years after treatment. The aim of this study is to see if a different approach can give patients a similar chance of being cured, but with far fewer of these challenging side effects. This could make a big difference to how well patients recover and their overall quality of life after treatment.

The new approach being tested involves giving chemotherapy first – this is called 'neoadjuvant' chemotherapy, meaning it's given before the main treatment. After the chemotherapy, the patient would have a special type of keyhole surgery called Transoral Robotic Surgery (TORS). This surgery uses small robotic tools to carefully remove the tumour. The hope is that by using this sequence of treatments, many patients might be able to avoid radiotherapy altogether, or at least have a much less intensive course of it. Researchers believe this could lead to better swallowing function and overall better quality of life compared to standard treatment, while still being highly effective against the cancer.

Key takeaways

This study explores a new treatment for HPV-related throat cancer.
It combines chemotherapy first, then robotic surgery, to potentially avoid radiotherapy.
A main goal is to reduce long-term side effects like swallowing problems and dry mouth.
Researchers hope this new method will improve recovery and quality of life.
This is a Phase 2 study, meaning it's still in earlier stages of testing.
It aims for similar cure rates to standard treatments, but with fewer harsh side effects.

Who may be eligible?

To be considered for this study, you would generally need to have a specific type of throat cancer (squamous cell cancer of the oropharynx) that is linked to HPV (p16 positive). The cancer should be at a certain stage (Stage III or IVa) and you must not have received any previous treatment for it. It's also important that the cancer hasn't spread to other distant parts of your body.

Doctors would need to confirm that you are generally well enough for surgery and that the tumour can likely be removed completely using the robotic surgery method. There are also specific requirements regarding your blood test results and kidney function, and you need to be over 18 years old. You won't be able to join if you have very advanced cancer that can't be removed, if the cancer isn't linked to HPV (p16 negative), or if you've already had certain types of chemotherapy or radiotherapy in the past.

Additionally, if you have other serious health problems that might interfere with the treatment or follow-up, or if your anatomy makes the robotic surgery difficult, you would not be eligible. Women who could become pregnant would also need to use effective contraception during the study. The study team will review all these details carefully with you.

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.

Is my throat cancer (oropharyngeal squamous cell carcinoma) specifically linked to HPV (p16 positive)?
Has my cancer been staged as III or IVa?
Have I received any previous treatment for this throat cancer?
Am I generally well enough for surgery?
Has my doctor confirmed the tumour is likely removable with robotic surgery?
Do I have any other serious health conditions that might interfere with treatment?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first receive a chemotherapy drug called Docetaxel. The exact number of chemotherapy cycles and the schedule would be explained by your medical team. Following the chemotherapy, you would then undergo Transoral Robotic Surgery (TORS) to remove the tumour, along with a neck dissection to check and remove any affected lymph nodes.

Throughout the study, you would have regular appointments with your medical team for check-ups, blood tests, and scans to monitor your health and how the treatment is working. This will help them keep track of any side effects and ensure your safety. The total duration of your participation would depend on your individual treatment plan and follow-up schedule, which the study team would clearly explain to you.

Potential risks and benefits

Participating in this study might offer potential benefits, such as a chance to receive a treatment that could lead to fewer long-term side effects like swallowing difficulties compared to standard radiotherapy. The goal is also to achieve a similar or better cure rate for your cancer. However, as with all medical treatments, there are potential risks involved. Chemotherapy can have temporary side effects like tiredness, nausea, and changes in blood counts, and surgery always carries risks such as infection or bleeding. The study team will discuss all possible risks and side effects with you in detail. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

McGill University Health Centre
Verified postcode
Montreal, Canada· Recruiting

Common questions

What is oropharyngeal cancer?

Oropharyngeal cancer is a type of throat cancer that affects the middle part of your throat, including your tonsils and the base of your tongue.

What does 'HPV-related' mean?

It means the cancer is caused by the Human Papillomavirus, a common virus that can affect different parts of the body.

What is Transoral Robotic Surgery (TORS)?

It's a type of keyhole surgery where a surgeon uses robotic tools through your mouth to remove tumours from your throat, avoiding large cuts on your neck.

Why are doctors looking for new ways to treat this cancer?

Current treatments are effective but can cause significant long-term side effects, especially with swallowing. Doctors hope to find treatments that are just as effective but with fewer side effects.

What is 'neoadjuvant chemotherapy'?

This is chemotherapy given before the main treatment, like surgery, to try and shrink the tumour or make it easier to remove.

How to find out more

Nader Sadeghi, MD

nader.sadeghi@mcgill.ca 514-934-1934 Official trial record

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