RecruitingNAINTERVENTIONAL

A Study Involving Neoadjuvant Chemoradiotherapy with Hypofractionated Radiotherapy in Patients with Esophageal and Gastroesophageal Junction Adenocarcinoma

This study is for people with esophageal cancer or cancer at the junction of the esophagus and stomach. It's testing a new approach called 'hypofractionated radiotherapy' alongside standard chemotherapy before surgery. This means the radiotherapy is given in fewer, stronger doses over a shorter period (one week), instead of the usual longer course. Researchers want to see if this quicker treatment is just as effective as the current, longer method. The aim is to make treatment more convenient for patients while still achieving good results. This is a Phase II study, meaning it's exploring the treatment's effectiveness and safety in a small group of people.

At a glance

Status

Recruiting

Phase

Sponsor

AHS Cancer Control Alberta

Enrolment target

Start

08 Feb 2023

Estimated completion

03 Feb 2028

Esophageal Cancer

What is this study about?

This study is for people who have been diagnosed with esophageal cancer or cancer at the point where the food pipe (esophagus) meets the stomach. This type of cancer is called adenocarcinoma. Doctors are always looking for ways to make treatments better and easier for patients, and this study focuses on the treatment given before surgery.

Currently, many patients receive a combination of chemotherapy and radiotherapy before their surgery. Radiotherapy usually involves several weeks of daily treatments. This study is exploring a newer way to give radiotherapy called 'hypofractionated radiotherapy.' This means you would receive the same total dose of radiation, but spread out over fewer, stronger treatment sessions – typically just one week, instead of several. The chemotherapy part of the treatment would stay the same. The main goal is to see if this shorter, more intense course of radiotherapy is just as effective at shrinking the tumour as the standard, longer course, while also being safe.

By shortening the radiotherapy period, the hope is to reduce the overall treatment time before surgery, potentially making it less disruptive to your life and easier to manage. This study compares this shorter radiotherapy approach with the standard treatment, to ensure it offers similar benefits in fighting the cancer before surgery.

Key takeaways

This study tests a quicker way to give radiotherapy with chemotherapy for esophageal cancer before surgery.
The new radiotherapy is given over one week instead of several, aiming to be just as effective.
It's for specific types of esophageal or gastroesophageal junction cancer.
Participation involves chemotherapy, one week of radiotherapy, followed by surgery.
You'll have regular checks and follow-ups throughout the study.

Who may be eligible?

This study is for adults generally aged between 18 and 80 who have been diagnosed with a specific type of esophageal cancer or cancer at the junction of the esophagus and stomach (adenocarcinoma). The cancer must be found in the lining of the food pipe or the top part of the stomach, and doctors must believe that surgery could potentially remove it entirely. This means the cancer shouldn't have spread to other distant parts of the body.

To join, you need to be well enough to go through the treatment, with your body's main organs (like your heart, lungs, kidneys, and blood) working adequately. Your cancer shouldn't be too large, and you must be able to start radiotherapy within 30 days of agreeing to take part. Women who could become pregnant must be using effective contraception.

There are also some reasons why you might not be able to join. For example, if you've had other cancers recently (unless it was a very minor skin cancer or a completely cured cervical cancer over 5 years ago), or if you've had previous chemotherapy or radiotherapy for this cancer. Certain heart conditions, significant nerve damage, active infections, or losing a lot of weight recently would also prevent you from taking part, as would mental health conditions that make it difficult to understand and agree to the study.

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.

Are you between 18 and 80 years old?
Do you have adenocarcinoma of the esophagus or gastroesophageal junction?
Has your doctor told you that your cancer has not spread to distant parts of your body and could potentially be removed by surgery?
Are your heart, lungs, kidneys, and blood counts generally healthy enough for treatment?
Are you able to start radiotherapy within 30 days of agreeing to join the study?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first sign a consent form. Within 30 days of this, you would begin a combination of chemotherapy and radiotherapy. The chemotherapy involves receiving two specific drugs through a drip into your vein once a week for five weeks.

The radiotherapy part, which is the focus of this study, would be given over just one week, sometime between the 3rd and 5th week of your chemotherapy. Doctors will aim for it to be in the 3rd week. After completing this combined treatment, you would have scans to see how the treatment has worked. Then, a few weeks later (ideally 6-8 weeks after your treatment finishes, but up to 12 weeks), you would have surgery to remove the cancer.

During your treatment, doctors and nurses will check on you weekly to monitor any side effects. After treatment and before surgery, you'll have checks every two weeks. About a month after your surgery, you will have a final follow-up appointment with the radiotherapy specialist to see how you are recovering.

Potential risks and benefits

Participating in this study might offer potential benefits, such as receiving a shorter course of radiotherapy, which could mean less time spent at the hospital for treatments. However, it's important to understand that this is a research study, and there's no guarantee the new approach will be better or even equal to standard care. As with all medical treatments, there are potential risks and side effects from both the chemotherapy drugs and radiotherapy, such as feeling unwell, fatigue, or soreness in the treated area. These will be carefully explained to you by the study team. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Tom Baker Cancer Centre/Arthur J.E. Child Comprehensive Cancer Centre
Verified postcode
Calgary, Canada· Recruiting

Common questions

What is 'hypofractionated radiotherapy'?

It means receiving a higher dose of radiation per treatment, but over fewer treatment sessions, so the whole course is shorter – in this study, it's just one week.

Will I still have surgery?

Yes, if you are suitable for this study, surgery to remove the cancer is still a planned part of your treatment after the chemotherapy and radiotherapy.

What kind of cancer is this study for?

This study is specifically for adenocarcinoma of the esophagus or the area where the esophagus joins the stomach.

How long will the treatment part of the study last?

The combined chemotherapy and radiotherapy treatment will last for about 5 weeks, with the radiotherapy part happening over one of those weeks. Then there's recovery time before surgery.

Can I choose not to have the new radiotherapy?

This study is testing this specific radiotherapy approach. If it's not right for you or you prefer standard treatment, your doctor will discuss other suitable options.

How to find out more

Sanjune Laurence Lee, MD

sangjune.lee@albertahealthservices.ca 587-231-6117 Official trial record

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