Phase I trials are the first studies tested on a small group of up to 60 people. Researchers aim to determine the safest dosage, identify possible side effects, decide the best ways to administer the medication, and understand how the treatment works in the body.
Understanding Clinical Trials for Cancer
Cancer research and clinical trials are essential to improving cancer treatment results and the side effects that can come with various therapies. Every breakthrough treatment available today is a result of the patients who participated in cancer research studies.
At Hematology-Oncology Associates of CNY (HOA), we are committed to providing patients throughout Central New York with access to emerging cancer treatments right here in our community through clinical trials for eligible patients. Through our clinical research program, patients at our East Syracuse, Camillus, and Auburn, New York cancer centers have the opportunity to participate in trials that make promising new therapies available close to home while also helping shape the future of cancer treatment.
If you or a loved one received a cancer diagnosis, understanding how clinical trials work can help you make informed decisions about your care.
Cancer Research Trials for All Types of Cancer
Cancer research trials are carefully planned studies with the goal of developing new and better treatments, screening methods, and preventative options for all types of cancer. Before any new medication, treatment, or procedure can become part of standard care, it must be thoroughly tested to make sure it is safe and effective. Each trial is carefully planned by oncologists and reviewed by an independent committee to ensure it’s safe, ethical, and scientifically appropriate, before patients who meet specific requirements are asked to participate.
Clinical trials are not a last resort for patients who have tried other treatments without success. Trials are available to patients at all stages. There may be some open to those who have tried other treatments as part of the participation requirement.
As mentioned, today’s standard cancer treatments exist because patients participated in clinical trials, and ongoing research continues to broaden cancer treatment methods and improve survival rates.
Types of Clinical Trials
Not all clinical trials focus on new medications. Researchers conduct different types of clinical trials with different goals. Clinical trial types include:
- Treatment trials: These evaluate new drugs, medical procedures, or combinations of existing treatments, including surgery, chemotherapy, radiation therapy, immunotherapy, and targeted therapy.
- Prevention trials: These studies look at ways to reduce the risk of developing cancer through lifestyle changes, medications, or other preventive measures.
- Screening trials: These studies evaluate new ways to detect cancer earlier, when treatment may be more effective.
- Quality-of-life trials: These studies focus on reducing symptoms, managing treatment side effects, improving comfort, and helping patients maintain quality of life.
How Cancer Research Trials are Conducted
Clinical trials for cancer are conducted based on strict scientific and ethical principles. Before each study starts, a protocol must be developed. This outlines the study’s details, including its objectives, who is eligible to participate, which treatments will be administered, how patients will be monitored, safety measures, and what information researchers may collect.
Clinical Trial Phases
Every new treatment must go through several phases before it becomes part of standard cancer care. Each phase builds upon the knowledge gained in studies done during earlier phases.
What Do the Research Phases Mean?
Clinical trials are led by a lead investigator and are classified in one of four phases to evaluate new treatments. Most therapies progress through Phases I, II, and III to prove safety and effectiveness. Some treatments may also include a Phase IV study after approval to monitor long-term outcomes.
Phase I
Phase II
Phase II studies evaluate a treatment’s effectiveness for specific types of cancer, while continuing to monitor side effects. Phase II groups involve more people than Phase I trials, but fewer than 100, all of whom meet specific requirements set by the investigators.
Phase III
Phase III trials compare a new treatment with the current standard of care. These larger studies help determine whether the new therapy offers better outcomes, fewer side effects, or additional benefits for patients. Successful phase III trials often lead to FDA approval and wider availability of the treatment.
Phase IV
After the FDA approves a treatment for a specific use, Phase IV studies are conducted to monitor its long-term safety, effectiveness, and patient outcomes. These trials may also explore new combinations of approved therapies to determine if they lead to improved results.
Randomization
Randomization is the process of assigning patients, at random, to groups that receive different treatments. In a simple trial design, the investigational group receives the new treatment, and the control group receives the standard therapy. Researchers compare the groups at different times during the trial to see which treatment is more effective or has fewer side effects.
Randomization is important because it helps prevent bias. Bias occurs when a trial's outcomes are influenced by the patient's or oncologist’s decisions or preferences.
Randomization happens in all Phase III trials and some Phase II trials.
Placebo
Many patients worry they may receive a placebo, or inactive treatment, during a cancer clinical trial. Placebos are rarely used in cancer treatment clinical trials. All patients who participate will receive life-saving treatment. If a comparison is used, the trial will assign a group of participants to receive the new treatment and another group to receive the already approved standard treatment.
What to Expect When Participating in a Clinical Trial
Before you agree to participate in a clinical trial, your cancer care team will provide you with detailed information, including the trial’s procedures, risks, and benefits. You will need to sign an informed consent document, confirming your understanding of all the details regarding the trial and your willingness to participate, which allows you to withdraw from the trial at any time.
It is very important to follow the treatment protocol and attend all appointments. Talk with your care team about any side effects, as these are also being studied during the trial, and support can be provided to help manage them.
After completing the trial, you will be scheduled for follow-up care. Your team will continue to monitor you to make sure the tested treatment was safe and effective. Follow-up appointments could last for months or even years, as this information helps researchers understand the long-term results and impact on quality of life.
Successfully conducting a clinical trial calls for a diverse range of cancer experts. The Clinical Research Team at HOA includes dedicated oncologists, nurses, and research coordinators. Throughout a cancer clinical trial, patients may interact with different team members who collaborate to manage, implement, and oversee every aspect of the clinical research process.
Benefits of Participating in a Clinical Trial
Participating in a clinical trial can offer benefits for both current and future cancer patients.
Some potential advantages include:
Access to emerging treatments: You will have the chance to use the newest therapies before they become widely available to the general public.
Personalized medicine: Your individual genetic markers, mutations, or DNA sequencing will be taken into account when determining the best treatment strategies.
Careful monitoring: You will be closely monitored for your response to the therapy, paying attention to any side effects. Clinical trial participants generally receive more frequent monitoring than those receiving standard cancer treatments, and this continues even after the trial ends.
Safety assurance: Treatments are closely regulated by the Food and Drug Administration (FDA), with rigorous testing protocols in place before any therapy is approved for human testing.
Convenient treatment locations: You have the option to receive treatment at an HOA cancer center conveniently located near you in the Syracuse area.
While clinical trials can provide additional treatment options, no study can guarantee a better outcome than standard cancer treatment. The clinical trials team will discuss enrolling in a trial if that is recommended for your specific diagnosis and treatment goals.
Watch Dr. Ajeet Gajra, medical oncologist at HOA, discuss the benefits of cancer research and clinical trials on our segment of Bridge Street, “Cancer Q&A with HOA.”
Learn more about choosing HOA for cancer clinical trial participation.
Find a Cancer Clinical Trial in the Syracuse Area
HOA’s clinical research program gives eligible patients access to innovative therapies close to home while continuing to receive care from providers they know and trust.
We offer clinical trials at our cancer centers located throughout Central New York, including areas in and around Syracuse, such as Camillus and all of Onondaga County, as well as Auburn and Cayuga County; Madison County (including Oneida), Oneida County (including Utica and Verona), Jefferson (including Watertown), and Oswego County (including Oswego and Fulton).
If you are curious about a clinical trial, you can check out answers to frequently asked questions about cancer research and trials. You can also talk with your care team at any time. If you are not yet a patient at HOA, call us at 315-472-7504, extension 1350.
