Clinical trials

Cancer Institute network and have access to many clinical trials. We tailor the clinical trials we offer with the needs of the community. We conduct phase II-IV drug trials some include surgical and radiation therapy. We also offer quality of life trials. Our affiliation with the Knight Cancer Institute means that that we can work closely with researchers to provide quality cancer care.

We use the same ethical and professional guidelines as larger academic medical centers and often exceed those standards. We are subject to the same federal standards and oversight as nationally recognized institutions.

Talk with your doctor to see if clinical trials are an option for you. To learn more, check out our frequently asked questions below or call our clinical research department at 503-814-1461.

Currently open clinical trials

Protocol: Aurora Research ADX02C

Title: Procurement of human bio-specimens for the discovery and validation or biomarkers for the prediction, diagnosis and management of oncologic disease
Treatment: No treatment. Tissue specimens are collected from remaining tissue obtained during standard treatment after all routine testing has been performed. Blood specimens are collected prior to routine surgery, and if possible collected during routine laboratory visit. If that is not possible, blood specimens are collected before surgery on the same day.
Eligibility:

Be at least 18 years of age or older
Be able to provide medical information relevant to the Collection Initiative in which they are participating.
Be capable of voluntarily signing, or have Legally Authorized Representative (LAR) sign the most current IRB/IEC approved Informed Consent and Authorization Form prior to participating.
Meet any additional inclusion criteria specified in all Core and peripheral collection initiatives.
Be able to provide the required bio-specimen types without compromising the current health status of the Subject OR alternatively have pre-existing bio-specimens suitable for inclusion in the Collection Initiative whereby additional collections are not necessary.

Protocol: Breast - A011202

Title: A Randomized Phase III Trial Comparing Axillary Lymph Node Dissection to Axillary Radiation In Breast Cancer Patients (cT1-3 N1) Who Have Positive Sentinel Lymph Node Disease After Neoadjuvent Chemotherapy.
Treatment: Patients will be randomized to two study groups if cancer-positive lymph nodes are identified during surgery or at final pathology. Patients will either have axillary lymph node dissection and radiation treatment combined, or only radiation treatment.
Eligibility:

Patients must be at least 18 years of age.
Clinical stage T1-3 N1 M0 breast cancer at diagnosis (prior to the start of neoadjuvant chemotherapy).
No inflammatory breast cancer.
No other malignancy within 5 years of registration with the exception of basal cell or squamous cell carcinoma of the skin treated with local resection only or carcinoma in situ of the cervix.
No neoadjuvant endocrine therapy.
No neoadjuvant radiation therapy.
More eligibility criteria must be met.

Protocol: CONNECT - AML/MDS

Title: The Myelodysplastic Syndromes (MDS) and Acute Myeloid Leukemia (AML) Disease Registry
Treatment: This is an observational study.
Eligibility:

Must be able to provide written informed consent form (ICF)
Newly diagnosed,* primary or secondary MDS or AML, or ICUS
Cohort assignment confirmed by Central Eligibility Review
AML patient must be at least 55 years of age at the time of ICF signature
MDS/ICUS patient must be at least 18 years of age at the time of ICF signature
Must be willing and able to complete enrollment and follow-up HRQoL instruments, for which patients must be proficient in either English or Spanish.

Protocol: CLL - EA9161

Title: A Randomized Phase III Study of the addition of Venetoclax to Ibrutinib and Obinutuzumab versus Ibrutinib and Obinutuzumab in Untreated Younger Patients with Chronic Lymphocytic Leukemia (CLL)
Treatment: Patients will be randomized to two study groups – either patients will be randomized to Arm A with Ibrutinib, obinutuzumab, venetoclax, or Arm B with Ibrutinib and obinutuzumab.
Eligibility:

Diagnosis of CLL according to the NCI/IWCLL criteria or SLL according to the WHO criteria.
No prior chemotherapy, BTK inhibitor therapy, venetoclax, small molecule signaling inhibitor, or monoclonal anti-body therapy for treatment of CLL or SLL
Age ≥ 18 years and < 70.
ECOG performance status between 0-2.
Life expectancy of ≥ 12 months.
More eligibility criteria must be met.

Protocol: Lung-MAP – LungMap Screening

Title: A Master Protocol to Evaluate Biomarker-Driven Therapies and Immunotherapies in Previously-Treated Non-Small Cell Lung Cancer
Treatment: After completing screening, participants have the option to be assigned to a sub-study based off the biomarker findings.
Eligibility Screening Criteria:

Patients must have pathologically proven non-small cell lung cancer (all histologic types) confirmed by tumor biopsy and/or fine-needle aspiration.
Patients must either be eligible to be screened at progression on prior treatment or to be pre-screened prior to progression on current treatment.
Patients must not have a known EGFR mutation or ALK fusion
Patients must be ≥ 18 years of age.
Patients must have adequate tumor tissue available, defined as ≥ 20% tumor cells and ≥ 0.2 mm3 tumor volume
More eligibility criteria must be met.

Protocol: Get Fit Prostate

For additional information, call 503-346-0444 ext. 2

E-mail: mailto:exercise@OHSU.edu/getfitprostate

WWW.ohsu.edu/getfitprostate

Salem Health exercise site will start in October 2019.

Get Fit Prostate (Group Exercise Training for Fall prevention and functional Improvements during and after Treatment for Prostate cancer). The study is a 3-group, single-blind, parallel design randomized controlled trial in prostate cancer survivors treated with ADT. Participants in each study group will attend supervised 1-hr classes, 3 days a week for 6 months.

ARM 1: Tai ji quan, an integrated exercise routine consisting of 8 purposeful movement forms and a set of therapeutic movements, specifically designed to challenge limits of stability and train gait patterns, as reflected in movements such as upright trunk positioning, displacement of body's center of mass over the weight-bearing leg, and step initiation, locomotion, and termination.

ARM 2: Strength training. Participants wear a weighted vest while performing exercises using functional movement patterns that challenge balance by using muscle groups and movement involved in everyday activities (chair rises, 90°squats, side-to-side squats, toe raises, lunges (forward, lateral, backward, walking), multi-directional step ups).

ARM 3: Stretching control. Participants in the control group will attend a supervised flexibility program of the same total weekly duration as the experimental arms (e.g., 3, 60-min sessions per week). Control participants will perform a series of whole body stretching exercises, according to the ACSM guidelines for flexibility training, with a focus on developing and maintaining a healthy back.

Six Month Follow-Up: Participants will be followed for an additional 6 months after the 6-month supervised intervention stops to track falls (using same monthly report used during intervention phase). Exercise questionnaires to track participation in home or community exercise programs and will be collected at the 9- and 12-month time periods.\

Inclusion Criteria:

Diagnosed with histologically confirmed prostate cancer.
Currently on ADT for >= 6 months OR not currently receiving ADT, but received >= 6-month course within the last 10 years.
Completed any surgery, radiation or chemotherapy ≥ 6 weeks prior to enrollment and no concurrent adjuvant therapy other than ADT for prostate cancer
Meets criteria for having experienced ≥1 fall in the last year (confirmed by self-report on Health History Questionnaire) or if no falls, meets criteria for slow TUG time (≥12.0 seconds) OR slow chair stand time (≥10.0 seconds).

Exclusion Criteria:

Current participation in moderate-vigorous intensity lower-body strength training two or more times per week for 30 minutes or more or participating in tai chi two or more times per week for 30 minutes or more.
Cognitive difficulties that preclude answering the survey questions, participating in the exercise classes or performance tests, or providing informed consent.
A medical condition, movement or neurological disorder, or medication use that contraindicates participation in moderate intensity exercise.
Not medically cleared for participation in moderate intensity exercise.

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Frequently asked questions about clinical trials

Frequently asked questions

What is a clinical trial?

Clinical trials are designed to answer specific questions and find better ways to prevent, diagnose and treat illness. Cancer clinical trials often compare the most accepted cancer treatment with a new type of treatment. The hope is that the new treatment will be better.

What doctors learn from these trials may help people with cancer in the future.

Talk with your doctor or call the Salem Health clinical research department (503-814-1461) to see if clinical trials are an option for you.

Why should I participate?

Being part of a clinical trial is to your advantage because:

Investigated treatments may turn out to have better results than the standard treatment.
A nurse trained in clinical research monitors each patient. This means you’ll get plenty of personal attention.
Depending on the study, medication may be provided by the sponsor of the trial.
Participation gives you the added satisfaction of knowing you’re helping future patients.
You’ll get the latest experimental treatments close to home while remaining in the care of your regular cancer specialist.

What are the risks of participation?

If you choose to take part in a clinical trial, please be aware of the following risks.

Lose time at work or home due to spending more time in the hospital or doctor’s office than usual.
You may need to provide sensitive or private information that is not normally provided.
The study doctors do not know who will or will not have side effects.
Some side effects may go away soon, last a long time, or never go away.
Some side effects may interfere with your ability to have children.

How do I know whether I can participate?

Each study has its own guidelines about who can participate.

Generally, participants in a study have things in common. These commonalities could include the type of cancer, age, gender, and previous treatments. To find out if you are eligible for a study, talk with your doctor or call the Salem Health clinical research department at 503-814-1461.

Is the care free?

No. Patients receive bills the same as if they are not participating in a study. In some cases:

Participating in a study can lead to higher costs. Potential patients should discuss cost with their insurance company.
The study sponsor may provide the study medication free of charge. Potential patients must sign an informed consent document before participation. This document thoroughly describes what is paid for by the study.

Are all the studies treatment studies?

No. There are a variety of types of studies, including prevention, tissue analysis and quality-of-life.

Are all patients on chemotherapy studies treated in the hospital?

No. Most patients receive their treatment in the outpatient setting.

Can I drop out of the clinical trial?

Yes. Patients have the right to stop their participation in a study at any time, for any reason. Patients considering dropping out should discuss it with their doctor before deciding. Written notification may be a requirement if you no longer want to participate. It is important to know that there are no penalties for withdrawing from a study. Your regular cancer care will continue. You will not be able to continue taking any study provided medications if you drop out.

In some cases, the principal investigator may end your participation in this study, whether you agree or not. Examples of this include, but are not limited to the following:

The principal investigator believes it is in your medical best interest.
New information becomes available about how to better treat your condition.
New information about the study treatment suggests it may be ineffective or unsafe for you.
It is unlikely, but the sponsor may end the study early.

What cancer clinical trials will Medicare pay for?

Medicare will pay for most cancer treatment clinical trials that are part of:

The National Cancer Institute (NCI)
Cooperative Group Studies
Federal Government Funded Studies

If you are in Medicare Advantage (Medicare managed care plan), you must revert to a regular Medicare plan. This is a requirement of the Centers for Medicare and Medicaid Services. You should contact someone at your plan before starting a clinical trial. They can provide information about any additional costs of participating in clinical trials.

Are clinical trials monitored?

Federal standards regulate clinical trials. For your safety, we conduct clinical trials under strict ethical and professional guidelines. In addition, physicians, scientists and community members monitor all studies. This helps ensure the least possible risk to volunteers.