Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

ATTENUATION – A multicenter randomized phase II study of the efficacy and safety de-escalation versus standard adjuvant chemotherapy in patients with low risk localized gastroesophageal adenocarcinoma (study PRODIGE/FRENCH 39)

This research study, called ATTENUATION, is investigating new ways to treat stomach or gullet cancer after surgery. This type of cancer is called gastroesophageal adenocarcinoma. All patients in the study have had surgery to remove their cancer and have already received some chemotherapy before the operation. They also have a low risk of the cancer coming back. The study compares two groups: one group receives the standard amount of chemotherapy after surgery, and the other group receives a reduced amount. The main goal is to see how many people are still alive three years after starting the study. Researchers will also look at side effects, quality of life, and if the cancer comes back. This helps doctors learn if less treatment can be just as effective while causing fewer side effects.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Centre Leon Berard

Enrolment target

120

Start

23 Jul 2024

Low risk of disease recurrence defined by the following criteria: - Absence of lymph node involvement (ypN0)assessed on a min. of 15 lymph nodes and - Either ypT0-2 ( all TRG grade) or ypT3 (with TRG 1a-b according to Becker classification or TRG1-2 according to Mandard’s classification)Completed both pre-operative chemotherapy with a fluoropyrimidine-platinum containing regimen (FLOT 4 cycles) and microscopically complete (R0) resection prior to randomization non-metastatic (M0) gastric esophageal or gastroesophageal junction adenocarcinoma

What is this study about?

This study, known as ATTENUATION, is specifically for people who have been diagnosed with stomach, gullet (oesophagus), or gastroesophageal junction cancer. This is the area where the gullet joins the stomach. All patients taking part have had their cancer completely removed by surgery. They also received chemotherapy before their operation, which included medicines called fluoropyrimidine and platinum. Importantly, their doctors have determined they have a low risk of the cancer returning, meaning it hasn't spread to their lymph nodes (small glands that are part of the immune system) or beyond.

The main idea behind this study is to explore if a reduced amount of chemotherapy after surgery is as effective and safe as the standard amount. For years, doctors have used a specific course of chemotherapy after surgery for these types of cancers. However, chemotherapy can have significant side effects. This study aims to find out if giving less chemotherapy might still manage the cancer well, but with fewer unpleasant side effects, potentially improving patients' quality of life without increasing the risk of the cancer coming back.

Researchers will carefully compare the two groups of patients – those receiving less chemotherapy and those receiving the standard amount. They will look at how long people live, if the cancer returns, any side effects experienced, and how patients' general health and well-being are affected. They will also consider the cost implications and even how emotional well-being plays a part. The ultimate goal is to find the best way to treat these cancers, balancing effectiveness with how well patients cope with their treatment.

Key takeaways

This study compares standard chemotherapy after surgery with a reduced amount for certain stomach/gullet cancers.
It aims to find out if less chemotherapy can be just as effective and cause fewer side effects.
All participants have already had chemotherapy before surgery and a complete cancer removal.
The study focuses on patients with a low risk of their cancer returning.
Researchers will monitor survival, side effects, and quality of life over three years.

Who may be eligible?

To be considered for this study, you would need to be an adult, aged 18 or older.

You must have been diagnosed with cancer of the stomach, gullet, or the area where they meet. Before joining the study, you would have already undergone chemotherapy and then had surgery to completely remove the cancer. It's important that your doctors determined your cancer had a low risk of coming back, meaning it hadn't spread to your lymph nodes and was contained within the original area or nearby.

All patients in this study have had specific checks after their surgery to confirm these points, including looking at at least 15 lymph nodes and assessing how much the cancer had spread locally. Your medical team would discuss all these details with you to see if your specific situation fits the study's requirements.

Quick self-check

Are you 18 years old or older?
Have you been diagnosed with stomach, gullet, or gastroesophageal junction cancer?
Have you already had chemotherapy before your surgery?
Was your cancer completely removed by surgery?
Have your doctors told you that your cancer has a low risk of coming back (e.g., no spread to lymph nodes)?
Are you able to attend regular hospital visits for check-ups and treatment?

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

What does participation involve?

If you join this study, you will be randomly assigned to one of two groups, like flipping a coin. One group will receive the standard course of chemotherapy after your surgery, and the other will receive a reduced course. The chemotherapy involves a combination of medicines: Docetaxel, Oxaliplatin, Calcium Folinate, and Fluorouracil. You will receive these treatments at regular intervals over a set period.

Throughout the study, you will have regular hospital visits for check-ups, blood tests, and to assess any side effects you might experience. You will also be asked to complete questionnaires about your quality of life and how you are feeling generally. Doctors will keep track of your health over approximately three years to see how well the treatment is working and if the cancer returns. Some patients might also be asked to take part in additional questionnaires about their emotional well-being.

Potential risks and benefits

Taking part in this study may offer potential benefits, such as contributing to medical knowledge that could improve future treatments for people with similar cancers. If you are in the reduced chemotherapy group, you might experience fewer side effects compared to the standard treatment. However, all medical treatments carry potential risks, and chemotherapy can cause side effects like feeling sick, tiredness, or hair loss. The research team will carefully monitor you for any side effects. You have the right to withdraw from the study at any time, for any reason, without affecting your usual medical care.

Locations (1)

—
France

Common questions

What kind of cancer is this study for?

This study is for cancer of the stomach, gullet (oesophagus), or the point where they meet, after you've had surgery.

What is the main goal of this study?

The main goal is to see if giving less chemotherapy after surgery is just as good as the usual amount, by looking at how long people live after three years.

What are the two treatment groups?

Patients will be randomly put into one of two groups: one gets the standard amount of chemotherapy, and the other gets a reduced amount.

Will I still get my normal care if I leave the study?

Yes, you can leave the study at any time, and it will not affect the medical care you receive.

What do they mean by 'low risk' cancer?

It means your doctors believe your cancer is less likely to come back because it was completely removed by surgery and hadn't spread significantly.