What is a clinical trial?
Cancer (or oncology) clinical trials are research studies in which cancer patients help find better ways to prevent, diagnose, and treat cancer. Clinical trials can be another treatment option for cancer patients. Nearly all treatments we now have for cancer were discovered as a result of clinical trials. Clinical trials only include patients who choose to take part.
What are the possible benefits of participating in a clinical trial?
The benefits for patients participating in a clinical trial may include:• access to the most recent treatments
• the hope for a cure for their condition
• the hope for a longer life
• the possibility of an improved quality of life
• minimizing side effects of certain treatments
• second opinions by the national research cancer doctors working on the studies
• intense monitoring and follow-up of the disease and treatment
• making an important contribution to the advancement of cancer treatments and knowledge
Who can participate in a clinical trial?
Each study has specific requirements that patients must fit in order to participate in a clinical trial. Eligibility for a clinical trial may depend on the type or stage of cancer, as well as the patient’s general health status. Patients who are interested in clinical trials will be evaluated based on the requirements of the study to see if they are eligible.
What are the different types of clinical trials?
There are many types of clinical trials. Your doctors, nurses, and clinical research team can help you decide what types of clinical trials may be right for you. Some types of clinical trials include:
- Prevention trials use new approaches to preventing cancer in people who have never had cancer or to prevent cancer from coming back. Many of these approaches use medicines, vitamins, minerals, or other supplements.
- Treatment trials test new cancer drugs, new combinations of drugs, new schedules of drugs, or new approaches to radiation therapy or surgery.
- Screening trials try to find the best way to find cancer, especially in the early stages when it is most curable.
- Symptom-control trials test new approaches, medicines, or supplements to manage or prevent some of the side-effects of standard cancer treatments.
- Quality-of-Life trials look at different ways to improve a patient’s comfort and overall quality of life throughout the course of treatment.
What are the phases of clinical trials?
Phase I Trials: These initial studies look at how a drug should be given to patients (injection, by mouth, etc.). They also look at what the correct dose is and how often a drug should be given, as well as the safety of a drug. These trials usually enroll only a small number of patients.
Phase II Trials: These studies further test the safety of the drug and how well it works. These studies usually focus on a specific type of disease i.e., breast cancer.
Phase III Trials: These trials will test a new drug, a combination of drugs, or a new approach to a standard procedure (radiation therapy or surgery, for example). These studies usually enroll a much larger number of patients than Phase I or II studies. Patients are usually randomly assigned (like flipping a coin) into a treatment group. Many Phase III studies are conducted nationwide and sometimes internationally.
Source: National Cancer Institute (NCI) – www.cancer.gov
Available Oncology Clinical Trials
For breast cancer:
- S0800: Chemotherapy to reduce the cancer before surgery for inflammatory and locally advanced HER 2 negative breast cancer.
- NSABP B-39 / RTOG 0413: Partial breast irradiation for breast cancer patients treated with lumpectomy
- NSABP B-43: Radiation therapy with the addition of Herceptin for early stage, HER 2 positive ductal carcinoma in-situ treated with lumpectomy.
- SWOG S0221: Comparison of two schedules of approved chemotherapy drugs for the treatment of breast cancer.
- SWOG S1007: Evaluates the use of a tumor gene assay to identify patients for post-operative chemotherapy.
- NSABP B-47: Approved chemotherapy with or without Herceptin for patients after the breast cancer has been surgically removed.
- NCCTG MA-32: Postoperative use of metformin to reduce risk of breast cancer recurrence.
- CALGB 40502: Comparison of 3 different chemotherapy agents with or without the addition of Avastin for treatment of advanced stage breast cancer.
- NSABP DMP-1: Study regarding decision making of women who do not have breast cancer but are at high risk. The study consists of a questionnaire about factors that affect the decision of whether or not to take medications to reduce the cancer risk.
- KUMC: Questionnaire study to learn more about symptoms of breast cancer and side effects of chemotherapy in order to better understand what women with breast cancer may experience.
For gastrointestinal cancer:
- CALGB 80702: Standard chemotherapy for patients with colon cancer whose cancer has been surgically removed to prevent recurrence. Standard chemotherapy of 6 or 12 cycles are given to determine if fewer cycles (6) are as effective in preventing return of the cancer as the standard 12 cycles.
- CALGB 80405: Standard chemotherapy with the addition of either Avastin or Erbitux for the treatment of metastatic colon cancer.
- SWOG S0713: Chemotherapy and radiation followed by surgery for rectal cancer.
For renal cancer:
- SWOG S0931: Study to determine if Everolimus prevents return of kidney cancer after surgical removal.
For lung cancer:
- E1505: Standard chemotherapy with or without Avastin for the treatment of surgically removed non-small cell lung cancer.
- CALGB 50303: Comparison of two different chemotherapy regimens in the treatment of large B Cell lymphoma.
- Novartis CRAD001N2301: Follow up treatment with Everolimus for patients whose cancer has been successfully treated but the patient is at high risk for recurrence.
- John Wayne Institute MSLT-II: Comparison of sentinel lymph node removal with completion axillary node removal to sentinel lymph node removal alone.
- ECOG E1609: Comparison of ipilimumab to interferon to prevent recurrence of melanoma that has been surgically removed.
For primary liver cancer:
- ECOG E1208: Delivery of chemotherapy directly to the liver with or without the addition of Sorafenib for patients whose liver cannot be surgically removed.
For cancer in the bone:
- CALGB 70604: Comparison of 2 different dosing schedules of Zometa for the treatment of breast or prostate cancer that has spread to the bones or for treatment of multiple myeloma.
- SWOG S0702: Observation study to assess the incidence of osteonecrosis of the jaw in patients receiving Zometa for the treatment of bone cancer.
- Cancer Thriving and Surviving: Study for cancer patients who have completed treatment to determine if programs that have been proven to be effective to help people cope with fatigue, frustration, pain and stress are also effective for self-management of cancer.
Contact our clinical research staff
For questions about our oncology clinical trials program, please call 719-365-2406.
Schedule an appointment
If you, or someone you love, has been diagnosed with cancer, or you think there is a high risk of cancer, schedule a consultation or find a cancer doctor by calling 719-365-5800.
Please note: a consultation may require a physician's referral. Contact your doctor for more information about the diagnosis or treatment of a medical condition.
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Nurse Advice Line
For questions about cancer or for a list of available community health classes, ask our nurses at HealthLink by calling 719-444-CARE (2273).
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