Active not recruitingPHASE3INTERVENTIONAL

RT or No RT Following Chemotherapy in Treating Patients With Stage III/IV Hodgkin's Disease

This study, for people aged 15 to 70 with advanced Hodgkin's disease, explores whether having radiation therapy after a specific combination of chemotherapy drugs (MOPP/ABV) helps patients more than chemotherapy alone. Hodgkin's disease is a type of cancer that affects the lymphatic system. The chemotherapy drugs work to stop cancer cells from growing. Researchers want to find out if adding radiation therapy helps prevent the disease from returning and improves how long people live overall. Participants will be grouped by chance to either receive radiation after chemotherapy or to have no further treatment, allowing doctors to compare the outcomes fairly.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

European Organisation for Research and Treatment of Cancer - EORTC

Enrolment target

615

Start

01 Sep 1989

Lymphoma

What is this study about?

This clinical trial is designed for people who have advanced Hodgkin's disease, which is a type of cancer affecting the body's lymphatic system. Doctors are trying to find the best way to treat this condition. All patients in this study will first receive a specific type of strong chemotherapy, which is a combination of several drugs like bleomycin, doxorubicin, and others. These drugs work by attacking and killing cancer cells.

Once the initial chemotherapy is finished, if the disease has improved, patients will be randomly assigned to one of two groups. One group will then receive additional treatment called radiation therapy. Radiation therapy uses high-energy rays to destroy any remaining cancer cells. The other group will not receive any further treatment and will be closely watched. The main goal is to see if adding radiation therapy after chemotherapy helps prevent the Hodgkin's disease from coming back and if it helps people live longer compared to only having chemotherapy.

By comparing these two groups, doctors hope to learn if radiation therapy provides an extra benefit for people with advanced Hodgkin's disease. This information will help them decide on the best treatment plans for future patients. This is a "Phase III" study, which means it's a large trial aiming to compare a new treatment approach with current standards.

Key takeaways

This study is for advanced Hodgkin's disease.
It compares chemotherapy plus radiation versus chemotherapy alone.
All participants receive initial chemotherapy.
Patients are randomly put into radiation or no radiation groups.
The goal is to see if radiation helps prevent cancer return and improves life expectancy.
Participants must be 15-70 years old and have good general health.

Who may be eligible?

To join this study, you need to have been diagnosed with advanced Hodgkin's disease (specifically Stage III or IV) that has been confirmed by examining tissue samples. Your general health should be good enough to go through the treatments, meaning you shouldn't have any severe heart, lung, kidney, or liver problems that would make these treatments unsafe for you.

You must be between 15 and 70 years old. You cannot have had any previous treatment for your Hodgkin's disease. Also, you shouldn't have any other serious health conditions that might interfere with taking part in the study, and you must not have had other cancers in the past, except for certain types of skin cancer or early-stage cervical cancer.

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.

Have you been diagnosed with advanced Hodgkin's disease (Stage III or IV)?
Are you between 15 and 70 years old?
Have you NOT had any previous treatment for your Hodgkin's disease?
Do you feel generally well enough to undergo cancer treatments, without severe heart, lung, or other major health issues?
Do you have no other serious cancers (except specific types of skin or cervical cancer)?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will first receive a combination of seven chemotherapy drugs. This chemotherapy is given in cycles. After completing the chemotherapy, if your disease has responded well, you will then be randomly assigned to one of two groups. One group will receive radiation therapy to the area where the disease was present. The other group will not have any further treatment but will be carefully monitored.

Throughout the study, you will have regular visits with the medical team. These visits will involve check-ups, blood tests, and scans to see how you are responding to treatment and to monitor for any side effects. The exact number of visits, tests, and the total duration of your participation will depend on which group you are in and how you respond to treatment, but the team will explain the full schedule to you.

Potential risks and benefits

Taking part in this study could potentially offer benefits, such as receiving treatment that might be more effective in preventing your Hodgkin's disease from returning or helping you live longer. However, there are also potential risks involved. Chemotherapy drugs can cause side effects like feeling sick, tiredness, hair loss, and an increased risk of infection. Radiation therapy can also cause side effects, depending on the area treated, such as skin irritation or fatigue. Your medical 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 future medical care.

Locations (56)

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

Algemeen Ziekenhuis Middelheim
Verified postcode
Antwerp, Belgium
A.Z. St. Jan
Verified postcode
Bruges, Belgium
Hopital Universitaire Erasme
Verified postcode
Brussels, Belgium
C.H.U. Saint-Pierre
Verified postcode
Brussels (Bruxelles), Belgium
Institut Jules Bordet
Verified postcode
Brussels (Bruxelles), Belgium
Centre Hospitalier Universitaire Brugmann
Verified postcode
Brussels (Bruxelles), Belgium
Centre Hospitalier Universitaire de Tivoli
Verified postcode
La Louvière, Belgium
U.Z. Gasthuisberg
Verified postcode
Leuven, Belgium
U.Z. Sint-Rafael
Verified postcode
Leuven, Belgium
National Cancer Institute of Egypt
Verified postcode
Cairo, Egypt
Institut Bergonie
Verified postcode
Bordeaux, France
Centre Regional Francois Baclesse
Verified postcode
Caen, France

Common questions

What is Hodgkin's disease?

Hodgkin's disease is a type of cancer that starts in white blood cells called lymphocytes, which are part of the body's immune system. It can develop in lymph nodes, spleen, liver, bone marrow, and other areas.

What is 'Stage III/IV' Hodgkin's disease?

This means the cancer is advanced. Stage III means it's in lymph nodes on both sides of the diaphragm, or in one area and the spleen. Stage IV means it has spread beyond the lymph nodes to other organs, like the liver or bone marrow.

What is chemotherapy?

Chemotherapy uses powerful drugs to kill fast-growing cells in the body, including cancer cells. It's often given through a drip into a vein.

What is radiation therapy?

Radiation therapy uses high-energy rays, like X-rays, to destroy cancer cells and shrink tumours. It's usually given by a machine outside the body.

Can I choose not to have the radiation?

If you take part in the study and your disease responds well to chemotherapy, you'll be randomly assigned to either the group receiving radiation or the group receiving no further treatment. This 'random' assignment helps ensure the study is fair and accurate in comparing the different approaches.