RecruitingNAINTERVENTIONAL

ISRT 20 Gy for Indolent Localized Gastrointestinal (GI)-Lymphoma

This research trial is investigating a lower dose of radiation therapy (20 Gy) for people with specific types of early-stage lymphoma in their stomach or part of their small intestine (duodenum). These lymphomas are often slow-growing, also called "indolent." The main goal is to see if this gentler dose is as effective as the slightly higher dose (30 Gy) usually recommended in shrinking the lymphoma after six months. Researchers will also be checking how this treatment affects patients' quality of life, their survival, and any side effects. By using a lower dose, the hope is to achieve good results with potentially fewer side effects.

At a glance

Status

Recruiting

Phase

Sponsor

University Hospital Muenster

Enrolment target

Start

01 Sep 2019

Estimated completion

31 Aug 2025

Follicular Lymphoma (Gastric or Duodenal)Marginal Zone Lymphoma (Gastric or Duodenal)

What is this study about?

This clinical trial is designed for people who have a specific type of cancer called lymphoma, located in their stomach or the first part of their small bowel (called the duodenum). These particular lymphomas are known as "indolent," meaning they tend to grow slowly. The study is focusing on two types: follicular lymphoma and marginal zone lymphoma.

The main idea behind this trial is to see if a lower dose of radiation therapy can be just as effective as the standard, slightly higher dose. Radiation therapy uses high-energy rays to kill cancer cells or stop them from growing. By using a dose of 20 Gy (measured in Gray, a unit for radiation), compared to the usual 30 Gy, doctors hope to achieve the same good results while potentially reducing side effects and making the treatment easier for patients. The radiation will be given in 10 small daily treatments over two weeks.

Researchers will closely monitor how well the lymphoma responds to this treatment after six months. They'll also be collecting information on patients' overall health, how they feel (their quality of life), if any side effects occur, and how long people live after treatment. This will help them understand the full impact of this lower-dose radiation approach. They'll also be looking at certain markers in the blood to see if they can predict how well someone will respond to treatment.

Key takeaways

This study tests a lower, potentially gentler, radiation dose for stomach/duodenal lymphoma.
It aims to see if 20 Gy is as effective as the standard 30 Gy.
Researchers will monitor lymphoma response, quality of life, and side effects.
Open to adults 18+ with certain early-stage, slow-growing lymphomas.
Participation includes radiation sessions, follow-up tests, and questionnaires.
You can stop participating at any time.

Who may be eligible?

To be able to join this study, you would need to have certain types of slow-growing lymphoma (marginal zone or follicular) in your stomach or duodenum. Your lymphoma should be considered early-stage, meaning it hasn't spread widely. It's also important that you haven't received radiation treatment to your gut for lymphoma before.

You would need to be 18 years old or older and generally well enough to take part in the study activities. If you have serious health problems that might make radiation treatment unsafe, such as severe heart or lung disease, or certain infections like HIV or active hepatitis B or C, you wouldn't be able to join. Also, if you are pregnant or breastfeeding, or if you have a condition that prevents you from understanding the study information, you wouldn't be eligible.

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.

Do I have slow-growing lymphoma (marginal zone or follicular) in my stomach or duodenum?
Is my lymphoma considered early-stage (Ann Arbor Stage I or II)?
Am I 18 years old or older?
Have I NOT had radiation treatment to my gut for lymphoma before?
Do I have any serious health conditions like severe heart disease, lung disease, or certain infections that might prevent me from having radiation?
Am I pregnant or breastfeeding?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive low-dose radiation therapy over two weeks (10 sessions). After your treatment, you'll have regular follow-up appointments over time to check how you're doing. These will include check-ups with the doctor, blood tests, and scans to see how the lymphoma responds. Researchers will also ask you to fill out questionnaires about how you're feeling and your quality of life. The study involves close monitoring of your health, any side effects you might experience, and your lymphoma's progress over an extended period.

Potential risks and benefits

Taking part in this study might mean you receive an effective treatment for your lymphoma with a potentially lower risk of side effects compared to a higher radiation dose. The information gathered could also help future patients with similar conditions. However, as with any medical treatment, there are potential risks, including side effects from the radiation, which will be carefully monitored. There's no guarantee that the treatment will work for everyone. Remember, your participation is voluntary, and you are free to withdraw from the study at any time without affecting your medical care.

Locations (1)

Department of Radiation Oncology
Verified postcode
Münster, Germany· Recruiting

Common questions

What is 'indolent' lymphoma?

Indolent means the lymphoma is slow-growing and often less aggressive than other types of cancer.

What does a '20 Gy' dose of radiation mean?

20 Gy (Gray) is a unit that measures the amount of radiation given. In this study, it's a lower dose compared to the usual treatment.

Will I have to stay in the hospital for the radiation?

No, radiation therapy is typically an outpatient treatment, meaning you visit the hospital for each session and then go home.

What kind of side effects might I experience?

Side effects can vary, but generally, radiation to the gut can cause tiredness or some discomfort in the treated area. These will be closely watched.

How long will I be followed up after treatment?

You will have regular check-ups for an extended period after your treatment to monitor your health and the lymphoma.

How to find out more

Gabriele Reinartz, MD (Priv. Doz.)

gabriele.reinartz@ukmuenster.de +492518347358 Official trial record

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