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?
- What are the phases of a clinical trial?
- Breast cancer study
- Prostate cancer study
- Brain cancer study
- Lung cancer study
- National Quality of Life Study
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.
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. La Fase 1 del ensayo es el primer paso para probar un nuevo agente contra el cáncer en seres humanos. En estos estudios, los investigadores buscan la mejor forma de proporcionar el nuevo agente. 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. Este proceso determina una dosis segura y apropiada para usar en la Fase 2 del ensayo.
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. El nuevo agente se suministra a grupos de personas con un tipo de cáncer o tipos de cáncer relacionados, utilizando la dosis segura descubierta en la Fase 1 de los ensayos. Usualmente, todos los participantes reciben el mismo tratamiento.
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. Los investigadores quieren saber si el nuevo tratamiento es mejor, igual o peor que el tratamiento estándar. En la Fase 3 de los ensayos, los participantes son asignados al azar a uno o más grupos (también llamado "brazos"). En un estudio con dos grupos, a uno se le suministra el tratamiento estándar (grupo de control) y al otro se le suministra el nuevo tratamiento que está siendo probado (grupo de investigación). Los participantes de la Fase 3 de los estudios abarcan desde personas a las que recientemente se les diagnosticó el cáncer hasta aquellos con una enfermedad de consideración. La Fase 3 de los ensayos, en general, cuenta con cientos o miles de participantes.
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. La Fase 4 de los ensayos es utilizada para seguir evaluando la seguridad y efectividad a largo plazo de un tratamiento. La Fase 4 de los ensayos es menos común que las fases 1, 2 y 3 y se lleva a cabo después de que el nuevo tratamiento es aprobado para un uso estándar.
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.
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