Cancer Research & Clinical Trials

Cancer research through clinical trials has paved the way to make great strides in the treatment of cancer. Willamette Valley Cancer Institute and Research Center (WVCI) participates in clinical trials through Sarah Cannon Research Institute (SCRI), one of the world’s leading oncology research organizations conducting community-based clinical trials. SCRI has contributed to pivotal research that has led to the majority of new cancer therapies approved by the FDA today. Through our collaboration, we can provide patients with access to the latest in cancer treatment options through available clinical trials.

Several of our physicians here at Willamette Valley Cancer Institute and Research Center serve on SCRI research committees to help develop new protocols and to determine future studies. 

Purpose of Cancer Research Trials 

Clinical trials are research studies designed to develop new and better treatment therapies for all types of cancer. They are the centerpiece of the therapy-testing system in the United States. A clinical trial is often used to learn if a new cancer treatment is more effective and/or has fewer harmful side effects than the current, standard treatment. Because all new cancer treatment therapies must be evaluated through clinical trials, the more people who participate in cancer research trials, the sooner other cancer patients can benefit from life-saving treatment options.

There are four different types of cancer clinical trials, which include:

• Treatment trials, which test new drugs, medical procedures, or combinations of treatments
  
  
• Prevention trials, which look for better ways to prevent diseases by either doing something (called action studies) like making lifestyle changes, or taking something (called agent studies) such as certain medicines, vitamins, minerals, or dietary supplements (or a combination of them)
  
  
• Screening trials, which test new ways to find disease early, when it may be more easily treated
  
  
• Quality of life trials, which explore ways to improve comfort and quality of life for cancer patients 

How Clinical Trials are Conducted

Physicians and cancer researchers design clinical trials, and these trials are conducted according to strict scientific and ethical principles. Before each study begins, a protocol is developed describing both the process and the necessity of each part of the study. To ensure the study is conducted fairly, and patients are well-informed of their rights, third-party experts will review the protocol. Each study has eligibility criteria for who can or cannot participate in the study, which may include the type of cancer, past cancer treatment regimens, age, gender, medical history, and current health status.

Use of Placebos

A concern among patients is whether they may be given an inactive treatment, called a placebo. The use of placebos in cancer clinical trials is rare, but it does happen. In most trials, cancer research participants are either given the new treatment or they are given an existing treatment already approved to treat their cancer.

Randomization

Clinical trial randomization is the process of assigning patients by chance to groups that receive different treatments. A select number of people will receive the new treatment being tested (the investigational group), while others will receive the standard treatment (the control group) that is already available. Oftentimes, neither the doctor nor the patient knows which cancer treatment they are receiving. This is so the results cannot be influenced by conscious or unconscious bias. At several points during and at the end of the clinical trial, researchers compare the groups to see which treatment is more effective or has fewer side effects.

Randomization happens in all Phase III trials and some Phase II trials. 

Clinical Trial Phases 

Clinical trials are conducted in a series of steps, called phases, and each phase is designed to answer a separate research question. Most new cancer treatments only go through Phases I, II, and III, as Phase IV is not always necessary for proving a new cancer treatment safe and effective.

• Phase I: In Phase I cancer clinical trials, researchers test a study drug for the first time to primarily evaluate the safety of the new drug. This typically involves a small group of 15-30 people who are monitored very closely. No placebo is used in this phase.
  
  This phase may also look at:

• • Dosage range
  • How the new treatment should be administered (by mouth, vein, etc.)
  • The effects the treatment has on the body
    
    
• Phase II: In Phase II cancer clinical trials, special emphasis is given to determining whether the therapy has an effect on a certain cancer. While there is no placebo given, participants may be divided into groups, with each group receiving a slightly different dose or schedule that will tell the investigators which way appears to work best with tolerable side effects.

Phase II trials usually involve more people than the Phase I trials, but less than 100 people all meet specific requirements set by the investigators. 

• Phase III: In Phase III cancer clinical trials, the new treatment (or new use of a treatment) is compared with the current standard treatment for that type of cancer. In this phase, patients may be broken into smaller groups and randomized into different treatment groups. The number of people taking part in Phase III can range anywhere from 100 to several thousand.
  
  
• Phase IV: In Phase IV cancer clinical trials, the cancer therapy is tested after it has been approved for a specific use. They are used to collect information about a therapy’s long-term effect on the patient’s quality of life, length of life, and any unexpected long-term side effects.
  Phase IV trials may also be used to try new combinations of approved therapies to determine if there are better outcomes. 

Deciding if a Clinical Trial is Right for You

Our patients come first. If you qualify for an available clinical trial, our research specialists will reach out to talk to you. You will be given all of the information about potential benefits and risks, and provided a detailed explanation of the treatment being tested. Those who take part in clinical trials receive close, personal attention and careful monitoring. Participation is voluntary, and patients can withdraw from a clinical trial at any time. If your oncologist feels that it’s not effective for you, s/he may also elect to stop your participation. 

If you’re interested in participating in a clinical trial, your WVCI oncologist can help determine if you’re a candidate. Any cancer patients considering a clinical trial should know as much about it as possible, including what is being studied and what they can expect during the trial.