Clinical Trials

Cancer treatment studies are under way at Saint Raphael’s. Most of our current clinical trials focus on cancer patient’s quality of life, and treatments for cancers of the breast, prostate, and lung. Our research team is committed to searching for new ways to improve cancer patients’ quality of life while preserving the dignity of those who are not cured. Our hope is to find additional, and perhaps even better cancer treatments for patients.

Sponsored by a national cooperative research organization called the Radiation Therapy Oncology Group (RTOC) and funded by the National Cancer Institute (NCI), these multi-institutional trials are part of a larger effort taking place at more than 250 major research institutes throughout the United States and Canada.

To learn about specific treatment guidelines for each trial, call the McGivney Center at (203) 789-3545 or e-mail Pat Garofolo, M.S., B.S.N., study coordinator.

What is a clinical trial?
A clinical trial is a research study performed to answer specific questions about new therapies or new combinations of therapies. Information learned from a clinical trial helps improve health care and treatment. Each trial follows a protocol (a written detailed plan) that explains why there is a need for the study, what it is intended to do and how it will be conducted. Carefully conducted clinical trials are the quickest and safest way to find treatments for specific illnesses.

Who can participate in a clinical trial?
Each trial has specific criteria (eligibility criteria or rules) that must be satisfied. Examples of eligibility criteria are age, type of disease, severity of disease, and a participant’s history prior to any study treatment. Participants must have a similar degree of illness, so there is a likelihood they will respond to treatment in similar ways

What is an Informed Consent Form (ICF)?
This document describes the rights of study participants and includes details about the study, such as its purpose, duration, required procedures and key contacts. Risks and potential benefits are explained. After reading this document carefully, the participant will decide whether or not to sign it. An informed consent form is not a contract and the participant can withdraw from the trial at any time. Informed consent is an ongoing process throughout the study.

For more information, call the McGivney Center (203) 789-3545 or e-mail Pat Garofolo, M.S., B.S.N., study coordinator.

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Clinical trials are conducted in 4 phases. The trials at each phase have a different purpose and help scientists and clinicians answer different questions.

In Phase I (Safety) trials, researchers test a new drug or treatment in a small group of people, usually 15 – 80 participants, for the first time to evaluate its safety, determine safe dosage, and identify side effects. A Phase 1 trial is the first step in testing a new cancer agent in humans. In these studies, researchers look for the best way to deliver the new agent. During the trial, the dose is usually increased group-by-group in order to find the highest dose that does not cause unacceptable harmful side effects, called toxicity. This process determines a safe and appropriate dose to use in a Phase 2 trial.

In Phase II (How Well It Works) trials, the drug or treatment under study is given to a larger group of people, usually 100-300 participants.  Phase 2 trials begin to evaluate how well the new agent works against a specific type of cancer. The new agent is given to groups of people with one type of cancer or related cancers, using the dosage found to be safe in Phase 1 trials. Participants usually all receive the same treatment.

In Phase III (Comparing the New Treatment to the Standards) trials, the drug or treatment under study is given to thousands of people, usually 1,000 – 3,000 participants, with the disease to confirm its effectiveness, monitor side effects, compare it to commonly used standard treatment, and collect information that will allow the drug or treatment to be used safely. Researchers want to learn whether the new treatment is better than, the same as, or worse than the standard treatment. In Phase 3 trials, participants are randomly assigned to one of two or more groups (also called “arms”). In a study with two groups, one gets the standard treatment (control group) and the other gets the new treatment being tested (investigational group). Participants in Phase 3 studies range from people newly diagnosed with cancer to those with extensive disease. Phase 3 trials usually have hundreds or thousands of participants.

In Phase IV (Continuing Evaluation) post-marketing studies trials look for additional information including the drug’s or treatment’s risks, benefits and optimal use. Phase 4 trials are used to further evaluate the long-term safety and effectiveness of a treatment.  Less common than phase 1, 2, and 3 trials, Phase 4 trials take place after the new treatment has been approved for standard use.

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For more information, call the McGivney Center at (203) 789-3545 at the Hospital of Saint Raphael or e-mail Pat Garofolo, M.S., B.S.N., study coordinator.

Page last updated on Mar. 24, 2009