Every clinical trial is designed to answer specific questions about cancer treatment and its effect on patients.  Each study will have certain criteria that must be met by patients wishing to take part in the trial.  Your doctor / medical team will guide you to the most appropriate trials based on your type of lymphoma, its stage, prior treatments, and your general health.

Many patients feel that if they are involved in a clinical trial they are receiving the cutting edge treatment for their particular disease.  Others see this as an opportunity to help others by being a part of the research.  If you choose to participate, you must understand there are risks as well as possible benefits that will be involved in your treatment.

Before becoming involved in a trial, the doctors should explain to their best knowledge the possible risks associated with the treatment.  All the risks will not be known but most trials are based on previous experience with the treatment to be tested (or similar treatments) and do have expected side effects that need to be discussed.

Trials are grouped into three phases depending on where the treatment is in the path to becoming mainstream therapy:

Phase I - This phase studies the best way to give a treatment and how much treatment can be given safely. Typically the treatment has been laboratory tested with animals but scientists need to see how it works with human patients. This phase has the most risks; it is usually only offered to a small number of people who have not been helped by standard treatment or whose cancer has spread. Patients are monitored very carefully through treatment.

Phase II - This phase looks at the effect of the treatment on the cancer and the patient.

Phase III - Treatment at phase III has been shown to be safe and effective. In this phase the treatment is tested on a large group of patients to confirm the results found in phases I and II. The new treatment is also compared with the standard treatment.

Trial patients are carefully monitored throughout treatment which may include more examinations and tests than usual.  The patient will have certain responsibilities throughout the trial.  Accurate records and all appointments must be kept.  If the patient has problems or is not benefiting from the trial the medical team may suggest leaving the trial or the patient may leave for their own reasons.

Patients should be informed about the treatment and risks.  Some questions that should be asked include:

• Exactly what is being studied?  What are the projected outcomes / benefits?
• Who is sponsoring this trial (cancer organization, drug company, etc)?
• What kind of tests and treatments are involved?
• What is the expected outcome of my lymphoma with this treatment, without this treatment, and with the standard treatment? Also a comparison of treatment lengths.
• How long will the study last?
• How will it affect my daily life?  What are the side effects?
• Will I have to be hospitalized?
• What will this cost me?  Will it be covered by insurance?  Many times the treatment used in the trial is available at no cost to the patient.  Other times there will be costs involved and they may or may not be covered (to include hospitalization). Is the cost more than standard treatment?
• What type of long-term follow-up care will be provided and at what cost?
• What are my options if I am harmed by this treatment?

Informed consent is required for trial participation.  Informed consent means the patient has been informed of the expected risks and benefits of the trial and has been told about the nature of the treatment and what tests and examinations are to be expected.   For the patient to give informed consent these must be made clear before signing the consent form.  The form should be read carefully.  Ask questions.  It is important to remember that even if the patient signs the informed consent form the patient may, at any time, quit the trial.

Once the patient makes the decision to join a trial they will be randomly assigned to a group either receiving the standard treatment or the new treatment being studied.   The group receiving the standard treatment is called the control group.  The results of the study are based on a comparison of the control group and the group receiving the new treatment.

Knowledge gained from clinical trials has led to longer survival times and improved quality of life.  trials continue to be the link between standard treatments and new discoveries.

Children

NCI recommends all children be generally considered for clinical trials and be cared for by a multidisciplinary team of pediatric oncologists.

More Information

The US National Cancer Institute

Centerwatch

Centerwatch is a site is designed to be a resource both for patients interested in participating in clinical trials and for research professionals.

• Centerwatch listing of trials for lymphoma
• Centerwatch main page

Lymphoma Research Foundation Trial Information

• Information on Clinical Trials Hotline 
• Understanding Clinical Trials

HIV associated Lymphoma Resources

• UCSF HIV Cancer Clinical Trials Page

Other Resources

• The Coalition of National Cancer Cooperative Groups has a their TrialCheck™ tool 
• European Clinical Trials http://www.EORTC.be/

For more information on lymphoma, please see the following pages:

• Childhood Non-Hodgkin's Lymphoma: Chemotherapy
• Childhood Non-Hodgkin's Lymphoma: Treatment
• Childhood Hodgkin's Disease: Chemotherapy
• Childhood Hodgkin's Disease: Treatment

• Adult Non-Hodgkin's Lymphoma: Chemotherapy
• Adult Non-Hodgkin's Lymphoma: Treatment
• Adult Hodgkin's Disease: Chemotherapy
• Adult Hodgkin's Disease: Treatment

The Home Page - gateway to support and more:

• The Lymphoma Information Network