Active not recruitingNAINTERVENTIONAL

Randomized, Open-label, Two-arms, Phase III Comparative Study Assessing the Role of Involved Mediastinal Radiotherapy After Rituximab Containing Chemotherapy Regimens to Patients With Newly Diagnosed Primary Mediastinal Large B-Cell Lymphoma

This study is for people with a type of lymphoma called Primary Mediastinal Large B-Cell Lymphoma, which affects a specific area in the chest. After initial treatments like chemotherapy, doctors often use radiation. However, scans can sometimes show what looks like cancer but is actually just scar tissue. This trial uses special PET/CT scans to identify if the cancer is truly gone. If the scan shows no active cancer, patients will either receive radiation treatment or be carefully watched without radiation. The goal is to see if avoiding radiation is as effective as having it, potentially sparing some patients from unnecessary treatment while making sure their cancer stays away.

At a glance

Status

Active not recruiting

Phase

Sponsor

International Extranodal Lymphoma Study Group (IELSG)

Enrolment target

540

Start

01 Oct 2012

Estimated completion

17 Dec 2029

Primary Mediastinal B-cell Lymphoma

What is this study about?

This study is focusing on a specific type of cancer called Primary Mediastinal Large B-Cell Lymphoma. This is a type of blood cancer that starts in a gland located in the chest area, between your lungs. This cancer is usually treated with a combination of powerful medicines, often including chemotherapy and another drug called rituximab.

After these initial treatments, doctors usually consider giving radiation therapy. Radiation therapy uses high-energy rays to kill any remaining cancer cells. The challenge is that sometimes, even when the cancer is gone, the treatment area can still show changes on regular scans that look like leftover cancer, but are actually just harmless scar tissue.

In recent years, a special type of scan called a PET/CT scan has become very good at telling the difference between active cancer cells and scar tissue. This study wants to find out if patients who have had their initial treatments and whose PET/CT scan shows no active cancer actually need to have radiation therapy. They will compare giving radiation with just carefully watching these patients to see if both approaches are equally good at keeping the cancer from coming back. This could mean that some patients might avoid radiation if it's not truly needed.

Key takeaways

Focuses on a specific type of chest lymphoma.
Compares radiation therapy to careful monitoring after initial treatment.
Uses advanced PET/CT scans to check for active cancer.
Aims to see if radiation can be avoided for some patients.
Participants are randomly assigned to treatment groups.
Goal is to reduce unnecessary treatment while maintaining good outcomes.

Who may be eligible?

This study is for adults, aged 18 and over, who have been recently diagnosed with Primary Mediastinal Large B-Cell Lymphoma. You must not have received any previous treatment for this specific type of lymphoma. The cancer needs to be confirmed by special tests on tissue samples, and it should be mainly located in the chest, without spreading to other distant parts of the body like the spleen or bone marrow.

You also need to be fit enough to receive both chemotherapy and potentially radiation treatment. You must have already completed a specific type of chemotherapy that includes rituximab and another commonly used drug called an anthracycline (like CHOP or similar), and you must have had at least six cycles of rituximab. If you've had certain other cancers or specific heart problems in the past five years, or have HIV, you wouldn't be able to join. Pregnant or breastfeeding women cannot participate, nor can anyone whose personal circumstances might make it difficult to follow the study plan.

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 18 years old or older?
Have you been newly diagnosed with Primary Mediastinal Large B-Cell Lymphoma?
Is your lymphoma mainly in your chest and hasn't heavily spread to other distant body parts?
Are you generally fit enough for cancer treatments?
Have you completed at least 6 cycles of specific chemotherapy including rituximab?
Are you not currently pregnant or breastfeeding?

Answer every question to see your result.

What does participation involve?

If you join this study, after your initial chemotherapy and rituximab treatment, you will have a special scan called a PET/CT scan. If this scan shows no active cancer, you will then be randomly put into one of two groups. One group will receive radiation treatment to the affected area in your chest. The other group will be carefully monitored with regular check-ups and scans, but without radiation.

Both groups will be closely followed to see how well they do over time. The exact number of visits, specific tests, and total length of follow-up will be explained by the study team, but it will involve regular appointments to check your health and ensure the cancer has not returned. All patients will be followed for a duration to properly assess the effects of the intervention.

Potential risks and benefits

The potential benefit of taking part in this study is that you might be able to avoid radiation therapy if it turns out not to be necessary for your condition. This could mean fewer side effects associated with radiation. However, there is a small potential risk that, in the observation group, a hidden cancer might be missed, leading to a delay in appropriate treatment. The study is designed to carefully monitor all participants for this. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (85)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Norton Cancer Institute
Verified postcode
Louisville, United States
Mayo Clinil Rocheser
Verified postcode
Rochester, United States
MD Anderson Cancer Center
Verified postcode
Houston, United States
Centro de Hematologia y Oncologia Pavlovsky
Verified postcode
Buenos Aires, Argentina
Princess Margaret Hospital
Verified postcode
Toronto, Canada
Ruijin Hospital
Verified postcode
Shanghai, China
Faculty Hospital Brno
Verified postcode
Brno, Czechia
University Hospital
Verified postcode
Hradec Králové, Czechia
Faculty Hospital Kralovske Vinohrady
Verified postcode
Prague, Czechia
General University Hospital
Verified postcode
Prague, Czechia
University of Duisburg-Essen, Campus Essen
Verified postcode
Essen, Germany
A.O. SS. Antonio e Biagio e Cesare Arrigo
Verified postcode
Alessandria, Italy

Common questions

What is Primary Mediastinal Large B-Cell Lymphoma?

It's a type of blood cancer that starts in a gland located in your chest, between your lungs.

What is a PET/CT scan?

It's a special scan that helps doctors see if there are any active cancer cells in your body, different from harmless scar tissue.

Why are you comparing radiation to just watching?

We want to see if some patients can avoid radiation if their cancer appears to be gone after chemotherapy, as found by the PET/CT scan, potentially reducing side effects.

Will I get to choose which group I'm in?

No, you will be randomly assigned to either the radiation group or the observation group, like flipping a coin for fairness.

What if my cancer comes back during the study?

You will be carefully monitored, and if your cancer returns, you will receive appropriate medical treatment. The study team will discuss this with you.