Clinical Trials

Please contact our specially-trained research nurse to find out what clinical trials may be appropriate for your needs:
Rebecca W. Buscanera RNC, BSN, OCN, CCRP
Clinical Research Nurse
Cape Cod Healthcare, Inc.
Phone: 508-862-5799
Fax: 774-552-6915

Many people are interested in learning about clinical trials and many people are volunteering to participate in them. Research is a scientific and systematic way to look at the outcomes of a particular drug, device or other process to see how well it works including how safe it is.  Participating in research is a voluntary process.  The investigators designing and conducting the research, the institutions where the research may be conducted, the sponsors of the research and the federal government are all interested in minimizing the risks to participants involved in research.

As a patient undergoing a treatment plan that is part of research or standard therapy, there is a certain amount of risk involved.  As a participant in a clinical trial, you are always exposing yourself to some risk.  You need to decide if the risk is acceptable to you or not. You need to be sure you understand the research and ask as many questions as you can to make an informed choice.  Talk over what you have learned with your family, friends and health care providers. Learn as much as you can before you decide to participate.
This site will help link you to other resources and will tell you what trials Cape Cod Healthcare is participating in.

Clinical Trials at CCHC

Medical Oncology at Cape Cod Hospital and Radiation Oncology at both Falmouth and Cape Cod Hospitals participate in national and regional clinical research trials. If you are interested in speaking with someone at CCHC about clinical trials in Oncology, please call Rebecca Buscanera, RN, BSN, Certified in Oncology & Research at 508-862-5799.

SITE

Eligibility

Chronic Lymphocytic Leukemia

Connect CLL: The Chronic Lymphocytic Leukemia Disease Registry

Patients diagnosed with CLL starting treatment; willing to do quality of life assessment upon enrollment and every 3 months thereafter, for 5 years

BREAST

DFCI 06-169: Helping ourselves, Helping others: The Young Women’s Breast Cancer Study

Women < 40 presenting within 4 weeks of new breast cancer diagnoses—Must speak English

 

RTOG 1014: A Phase II study of repeat breast preserving surgery and 3-D conformal partial breast re-irradiation (PBRI) for local recurrence of breast cancer.

Women > 18 years of age with recurrent breast cancer on the same side; Prior lumpectomy & radiotherapy over 1 year ago; no skin involvement; Negative surgical margins; < 3.0 cm carcinoma; < 3 positive nodes without extracapsular extension.

SWOG 1007:  A phase III, randomized clinical trial of standard adjuvant endocrine therapy +/- chemotherapy in patients with 1-3 positive nodes, hormone receptor positive and HER2 negative breast cancer with recurrence score (RS) of 25 or less.

 

Women, 18 yrs of age or older,  with Invasive breast cancer that is ER and/or PR positive, Her 2 neg, and has 1-3 nodes positive

Patients can not have inflammatory breast cancer, metastatic disease;  prior malignancy; chronic treatment with systemic steroids or other immunosuppressive agents; prior breast radiation; prior preventative treatment withTamoxifen or Raloxifene treatment; and can not be pregnant or nursing.
 

PROSTATE

DFCI 05-043: Docetaxel plus 6-month Androgen Surpression and Radiation Therapy vs 6 month Androgen Surpression and Radiation Therapy for Patients with High-Risk localized or locally advanced prostate cancer: A randomized controlled trial.

Patients > 30 years of age; Stage: T2c, T3a, T3b, or T4; or T1b to T2b plus meet one other condition (see protocol). No metastases; Negative bone scan/lymph node assessment; No prior radiotherapy; No radical prostectomy.

RTOG 0534: A Phase III trial of Short Term Androgen Deprivation with Pelvic Lymph Node or Prostate Bed Only Radiotherapy (SPPORT) in Prostate Cancer Patients with Rising PSA after radical prostatectomy.

Select Patients with prostate cancer and no distant metastases; Stage: T3/T2 with no node involvement and positive surgical margin.

No prior pelvic radiotherapy; No androgen deprivation started prior to prostatectomy for > 6 months; no androgen deprivation therapy started after prostatectomy and prior to registration.

RTOG 0815: A Phase III prospective randomized trial of dose escalated radiotherapy with or without short term androgen deprivation therapy for patients with intermediate risk prostate cancer

Select patients with stage T2b-T2c; Intermediate risk; Node negative and clinically localized prostate cancer.

RTOG 0924– Androgen deprivation therapy and high dose radiotherapy with or without whole-pelvic radiotherapy in unfavorable intermediate or favorable high risk prostate cancer: A phase III randomized trial.

Select patients with newly diagnosed prostate cancer, negative lymph nodes by imaging and not metastatic to the bone.

Patients must not have had radiation, hormonal therapy, chemotherapy or surgery for their prostate cancer.

Lung Cancer

RTOG 1012:  Phase II randomized trial of prophylactic Manuka Honey for the reduction of chemoradiation therapy induced esophagitis related pain during the treatment of lung cancer. For patients receiving combination chemo & once daily radiation for lung cancer with no mets;
must be able to swallow thick liquids prior to treatment;

Patients can not have had prior chemo or XRT or poorly controlled diabetes; they must be able to complete required forms.

Arm 1: Standard supportive care
Arm 2: 10cc liquid Manuka honey 4 x day
Arm 3: 10cc equivalent Manuka honey in lozenge form  4 x day

Multiple Myeloma

DFCI 08-273:  Phase II trial of combination Plerixafor (AMD3100), Bortezomib & Dexamethasone in relapsed or relapsed/refractory multiple myeloma.

 

Greater than 18 years of age; 
Must have received 1-5 prior therapies and have relapsed or refractory (prior therapy with bortexomib is allowed, as long as not refractory to it).
Monoclonal protein in serum of > 1 gm/dl, or monoclonal light chain in urine > 200mg/24hrs, or measurable light chains by free light chain assay of > 10 mg/dl, or measurable plasmacytoma.
ANC > 1000 uL; PLT > 75,000/uL; total bili < 2.0 mg/dl; AST & ALT < 3x ULN
Estimated creatinine clearance > 60mL/min or a creatinine < 2.2 mg/dL

   
DFCI 10-106: A randomized, phase III study comparing conventional dose treatment using a combination of lenalidomide, bortezomib and dexamethasone (RVD) to high dose treatment with peripheral stem cell transplant in the initial management of myeloma in patients up to 65 years of age.

 
> 10% monocolonal plasma cells in bone marrow, monocolonal protein in serum and/or urine and myeloma related organ dysfunction (1 or more of CRAB). Pts must by symptomatic with measurable disease
Ages 18-65; ECOG 0-2;
Negative HIV test
 
 
Connect MM: The Multiple Myeloma Disease Registry
 
Newly diagnosed-up to 2 months prior to enrollment, symptomatic:
Presence of an M-component in serum or urine, plus clonal plasma cells in marrow, and or documented clonal plasmacytoma, plus end organ damage –one or more of the following:
Calcium > 11.5, Creatinine > 2, Hgb < 10, lytic lesions or osteopenia; 18 years of age or older
 
 

Brain Metastasis

   
RTOG 0671: Phase III Randomized trial of the role of whole brain radiation in addition to radiosurgery in patients with one to three brain metastasis.  One to three brain mets; <3.0 cm in maximal extent by MRI (MRI < 28 days prior to randomization)
> 18 years of age; ability to complete questionnaire(s) by themselves or with assistance;
ECOG performance status 0-2.
 
 

Policies and Forms

This web page is designed for investigators who are interested in performing research at any Cape Cod Healthcare entity.
The policies and forms have been reviewed by the Cape Cod Healthcare Institutional Review Board (IRB) and the Office of Research Compliance. Please be certain to review the policies and forms that are listed as “Required.”

Any research including human subjects must be submitted to the Office of Research Compliance, who will confer with the CCHC IRB Chairman. The IRB Co-Chairman will determine if the research requires review by the IRB.

That decision may not be made by an investigator alone. This includes students or staff of a CCHC entity who may want to pursue a research project.

Other links provide forms that may assist you with your application.  If you have any questions about the process please e-mail LShields@capecodhealth.org

CCHC Institutional Review Board

The federal regulations dictate that a group called an Institutional Review Board (IRB) must approve and oversee the research being conducted. The IRB at Cape Cod Healthcare is composed of physicians, nurses, pharmacists and community members. The community members are critical to an IRB to review the research from the point of view of the patient. They often bring up issues that clinicians are not aware of, because they think from the patient’s point of view. The IRB plays a critical role in safeguarding subjects’ rights and welfare during the recruitment process, informed consent process and the conduct of the clinical trial.

Federal Agencies Involved in Clinical Trials

Federal Agencies that have the primary responsibility of helping to ensure the rights and welfare of human subjects participating in the clinical research:

DEPARTMENT OF HEALTH AND HUMAN SERVICES (DHHS)

The Office for Human Research Protections (OHRP)
OHRP is an office of the DHHS.  OHRP ensures the rights and welfare of human subjects, establishes standards for the organizations review of research through the Institutional Review Board process.  The OHRP provides guidance and training to help IRBs. Sponsors of trials and Physicians must meet the Federal requirements.

Food and Drug Administration (FDA)
An office of the DHHS that regulates research in the products it oversees. In clinical trials, those are usually a new drug or new medical device. The FDA requires evidence of drug and product safety in the form of an application process and has rules about reporting of safety issues during clinical trials.

The Office of Good Clinical Practice
The Office of Good Clinical Practice is part of the FDA.  Its mission is to establish consistency in policy. They are charged with ensuring FDA’s protective role in clinical research, from the design of a trial through how the trial is conducted and overseen.

Who to Contact at CCHC about Clinical Trials

The most critical person to speak with is your doctor.
Others at Cape Cod Healthcare who are involved with clinical trials and who will be able to assist you are:
Director of Research Compliance    508-862-5812
Co-Chair of the CCHC IRB    508-846-9076
Co-Chair of the CCHC IRB    508-778-8835
Cancer Clinical Research Nurse    508-862-5799

Find a Physician

More than 450 physicians and specialists delivering exceptional and compassionate care.

Highlights

1
Cape Cod Healthcare has been named one of the nation's top 15 health systems by Truven Health Analytics.
Cape Cod Healthcare named one of the Top 15 Health Systems in the nation.
two new facilities under
construction that will enhance
patient access to vital services.
More than 36 million
Americans have seasonal
allergy problems.
Now open for Radiation
Therapy Program at
Falmouth Hospital

Contact Us

Cape Cod Hospital
27 Park Street
Hyannis MA 02601
Phone: 508-771-1800
Directions

Falmouth Hospital
100 Ter Heun Drive
Falmouth, MA 02540
Phone: 508-548-5300
Directions