Active not recruitingPHASE3INTERVENTIONAL

PET Scan in Planning Treatment in Patients Undergoing Combination Chemotherapy For Stage IA or Stage IIA Hodgkin Lymphoma

This study is for people with early-stage Hodgkin lymphoma. Currently, many people receive chemotherapy followed by radiotherapy. This study wants to find out if a special scan, called a PET scan, can help doctors understand how well the chemotherapy has worked. By seeing the scan results, doctors might be able to decide if some patients can safely avoid having radiotherapy, which could reduce side effects. All patients will have chemotherapy. Afterwards, if their cancer has responded well, they'll have a PET scan. Depending on the scan results, some will definitely have radiotherapy. Others will be randomly split into two groups: one receiving radiotherapy and one receiving no further treatment, to compare the outcomes. This helps researchers learn the best way to treat this type of cancer.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

University College, London

Enrolment target

602

Start

01 Jul 2003

Estimated completion

01 Dec 2028

Lymphoma

What is this study about?

This study is investigating the best way to treat people who have early-stage Hodgkin lymphoma. Hodgkin lymphoma is a type of cancer that starts in white blood cells called lymphocytes.

Currently, many people with this type of cancer receive a combination of chemotherapy drugs. After this, doctors often recommend radiotherapy (using high-energy rays to kill cancer cells) to the affected areas. However, radiotherapy can have side effects, and doctors want to find out if it's always necessary for everyone. This is where the special PET scan comes in.

The main aim of this study is to see if a PET scan, done after a few cycles of chemotherapy, can tell doctors if the cancer has responded so well that radiotherapy can be safely skipped for some patients. If the scan shows no active cancer remaining, it might be possible for some patients to avoid further treatment. This could help improve their quality of life by reducing treatment-related side effects, while still making sure the cancer is controlled effectively.

Key takeaways

This study aims to personalise treatment for early-stage Hodgkin lymphoma.
It uses a PET scan after chemotherapy to guide further treatment decisions.
Some patients might be able to avoid radiotherapy, reducing side effects.
Participation involves chemotherapy, scans, and possibly radiotherapy or no further treatment.
You will be closely monitored through regular follow-up appointments.

Who may be eligible?

This study is for adults generally aged between 16 and 75 who have been diagnosed with Hodgkin lymphoma that is in its early stages (Stage IA or IIA). The cancer must be above the diaphragm (the breathing muscle below your lungs) and meet specific size criteria.

You cannot join if you have been pregnant or are breastfeeding. Women who can get pregnant must use effective birth control during the study and for at least 6 months after. You also can't have other serious health conditions that might make the treatment unsafe, like severe heart or lung problems.

Importantly, you must not have received any previous treatment for Hodgkin lymphoma before joining this study. You also need to be willing to travel to a PET scan centre and be able to attend all the scheduled follow-up appointments.

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 early-stage Hodgkin lymphoma (Stage IA or IIA)?
Is your cancer located above your diaphragm and not too big around your chest?
Are you between 16 and 75 years old?
Have you had no previous treatment for your Hodgkin lymphoma?
Are you able to travel for PET scans and attend all follow-up appointments?
Are you able to use contraception if you could become pregnant?

Answer every question to see your result.

What does participation involve?

If you join this study, you will first receive three cycles of chemotherapy, given over approximately three months. Each cycle involves infusions of four different medications on two specific days, spaced two weeks apart. After the third cycle, you'll have a CT scan. If your cancer hasn't responded, you'll leave the study. If it has, you'll then have a PET scan.

Based on your PET scan results, if there are still signs of active cancer, you will receive one more cycle of chemotherapy and then radiotherapy. If your PET scan shows no active cancer, you will be randomly placed into one of two groups: one group will receive radiotherapy to the areas where the cancer was previously, and the other group will receive no further treatment. After your treatment ends, you'll have regular follow-up appointments, starting every three months and gradually becoming yearly, for several years, to monitor your health.

Potential risks and benefits

Participating in this study might offer you the benefit of receiving treatment that is specifically tailored to how your cancer responds, potentially allowing you to avoid unnecessary radiotherapy and its associated side effects. However, there's also a chance that if you are in the group that doesn't receive radiotherapy, your cancer might return sooner. All treatments carry risks, and the chemotherapy drugs used have known side effects. You will be closely monitored for any health issues. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

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

Christie Hospital
Verified postcode
Manchester, United Kingdom

Common questions

What is a PET scan?

A PET scan is a special type of imaging test that can show how well your body's tissues and organs are working. In this study, it helps doctors see if there are still active cancer cells after chemotherapy.

What is Hodgkin lymphoma?

Hodgkin lymphoma is a type of cancer that starts in your white blood cells, which are part of your immune system. It can affect your lymph nodes and other parts of your body.

Will I definitely receive less treatment in this study?

Not necessarily. The study aims to see if some people can safely have less treatment, but not everyone will. Your treatment path will depend on how your cancer responds to chemotherapy and the results of your PET scan.

What are the main side effects of the chemotherapy used?

The chemotherapy regimen (ABVD) can cause side effects like hair loss, feeling sick, tiredness, and a higher risk of infection. Your healthcare team will discuss these with you in detail.

How long will I be followed up after treatment?

You'll be followed up for several years after your treatment finishes. This starts with more frequent checks (every few months) and then becomes once a year to ensure your health is stable.