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Clinical Research


Dignity Health Cancer Institute of Greater Sacramento believes in the benefits of clinical research and its ability to elevate the level of care for all.

Cancer Research At Dignity Health Cancer Institute Of Greater Sacramento

In addition to giving patients access to the latest treatment options, our physicians develop expertise in decisions and outcome data. A particular technology may eliminate the need for more drastic surgeries, changing the standard of care. This is the value of a comprehensive research program and why it is an important part of the medical services we provide.

Breast Cancer

SWOG S1207

This is a Phase III, multicenter, randomized, placebo-controlled, double-blind study evaluating the use of 54 weeks of everolimus in addition to endocrine therapy.  Eligible patients would have been diagnosed with HER2 negative, hormone receptor (ER or PR) positive breast cancer and would have completed surgery, chemotherapy and radiation, if indicated.  Patients would be randomized to 54 weeks of either everolimus or placebo, supplied by the study, in addition to the endocrine therapy prescribed by their physician.  This study hopes to show that adding everolimus prior to recurrence can help prevent or delay the breast cancer from coming back.

Sponsor: NRG Oncology

Principal Investigator: Sonia Reichert, MD

Dr Reichert

Clinical Trials Website: ClinicalTrials.Gov

ABC Study

This is a Phase III, multicenter, randomized, placebo-controlled, double-blind study looking at the use of aspirin in patients with HER2 negative breast cancer.  Patient who have node positive breast cancer and who have completed their surgery, chemotherapy and radiation, if indicated, would be eligible to participate in the study.  Patients would be randomized to 5 years of aspirin or placebo, supplied by the study.  The study hopes to show that women taking aspirin after treatment for their breast cancer have a lower rate of recurrence than those who do not.

Sponsor: NRG Oncology

Principal Investigator:  Sonia Reichert, MD

Dr Reichert

Clinical Trials Website: ClinicalTrials.Gov

NRG-BR003

This is a Phase III, multicenter, randomized study looking at adding another type of chemotherapy to the standard treatment given to women with triple negative breast cancer.  Eligible patients will be newly diagnosed with TNBC (estrogen receptor negative, progesterone receptor negative and HER2 negative) and will have completed surgery.  The standard treatment for these patient is doxorubicin plus cyclophosphamide followed by paclitaxel.  In this study women will be randomized to receive this treatment or to have carboplatin added during the weekly paclitaxel treatments.  The goal of the study is to determine if adding carboplatin can reduce the chance of recurrence in patients with this type of breast cancer.

Sponsor: NRG Oncology

Principal Investigator: Sonia Reichert, MD

Dr Reichert

Clinical Trials Website: ClinicalTrials.Gov

E2112

The E2112 study is a Phase III trial for patients who have recurrence of their breast cancer after treatment.  Eligible patients will have hormone-receptor positive, HER2 negative breast cancer that has come back while on (or after finishing) endocrine therapy.  All patients will receive exemestane for their cancer.  Half of the patients will receive an additional medication called entinostat.  The other half of the patients will receive a placebo.  The study hopes to determine if the addition of entinostat can prevent further progression of the cancer.  This study is blinded.

Sponsor: NRG Oncology

Principal Investigator: Sonia Reichert, MD

Dr Reichert

Clinical Trials Website: ClinicalTrials.Gov

 

Gynecologic Cancer

RTOG-0724

This is a Phase III, randomized study for patients who have been diagnosed with high-risk, early-stage cervical cancer.  Eligible patients would have had a hysterectomy for their cancer.  All patients will receive the standard treatment which is chemotherapy (cisplatin) and radiation at the same time over a period of several weeks.  This study will give half of the participants additional chemotherapy after they complete the standard treatment.  The study hopes to determine if additional chemotherapy (carboplatin and paclitaxel) will improve participants disease free survival compared to not receiving the additional chemotherapy.  This study is not blinded.
 
Sponsor: NRG Oncology
 
Principal Investigator: Wiley Fowler, MD

 Dr Fowler | Dignity Health

Clinical Trials Website: ClinicalTrials.Gov

GOG-0263

The GOG-0263 study is a Phase III, randomized study for patients who have been diagnosed with intermediate-risk, early-stage cervical cancer.  Eligible patients would have had a hysterectomy for their cancer.  The standard of care treatment for these patients is radiation alone.  Patients in this study will be randomized to receive either radiation alone or radiation plus chemotherapy.  The radiation and chemotherapy are given concurrently (at the same time).  The GOG-0263 study will give half of the patients radiation alone and the other half will receive radiation plus chemotherapy.  The study is trying to determine if adding chemotherapy to the radiation will improve participants disease free survival compared to those not receiving the chemotherapy.  This study is not blinded.
 
Sponsor: NRG Oncology
 
Principal Investigator: Wiley Fowler, MD

 Dr Fowler | Dignity Health

Clinical Trials Website: ClinicalTrials.Gov

NRG-GY009

The GY009 study is for women with recurrent ovarian, fallopian tube or primary peritoneal cancers.  Eligible patients will be platinum-resistant.  This means they have progressed while on, or within 6 months after, a platinum containing chemotherapy.  Patients will be randomized to receive one of three possible treatment arms.  The standard of care arm is Doxil plus Avastin.  The other two arms are experimental and consist of Doxil plus Tecentriq or Doxil plus Avastin plus Tecentriq.  Doxil, Avastin and Tecentriq are all medications that are given by IV infusion. Researchers hope to determine if either of the experimental arms are more effective at preventing the spread of cancer than the standard of care arm.  This study is not blinded.

Sponsor: NRG Oncology

Principal Investigator:  Delphine Ong, MD

Dr Ong

Clinical Trials Website: Clinicaltrials.gov

Re-opening soon:  NRG-GY005

The GY005 study is for women with recurrent ovarian, fallopian tube or primary peritoneal cancers.  Eligible patients will be platinum-resistant.  This means they have progressed while on, or within 6 months after, a platinum containing chemotherapy.  Patients will be randomized to receive one of four possible treatment arms.  The standard of care arm is a choice of 3 possible IV chemotherapy regimens.  You and your doctor will determine which one is best for you.  Experimental arms include Lynparza alone, Recentin alone or a combination of Lynparza and Recentin.  Both Lynparza and Recentin are oral medications. Researchers hope to determine if either of the experimental arms are more effective at preventing the spread of cancer than the standard of care arm.  This study is not blinded. 

Sponsor: NRG Oncology

Principal Investigator: Delphine Ong, MD

Dr Ong

Clinical Trials Website: Clinicaltrials.gov 

 

Prostate Cancer

RTOG 0924

The RTOG 0924 study is for men who have been diagnosed with prostate cancer and have selected to have radiation combined with hormone therapy as their treatment.  This is a multicenter, randomized study trying to determine if giving radiation to the whole pelvis is better at preventing recurrence than giving radiation to the prostate alone.  Men in this study will be randomized to one type of radiation or the other.  This study is not blinded.

Sponsor: NRG Oncology

Principal Investigator: John Stevenson, MD

 Dr Stevenson

Clinical Trials Website: ClinicalTrials.Gov

 

Brain Metastases

METIS

The METIS study is for patients who have brain metastases from NSCLC.  Patients will receive treatment for their NSCLC with the best possible care as determined by their physician.  All patients will receive radiotherapy with SRS initially to treat their brain mets.  Half the patients in this study will also receive Tumor Treating Fields (TTFields) applied to the head.  The other half of the patients will receive the best supportive care of their brain mets.  The study hopes to show that the addition of TTFields will slow or stop the progression of the cancer in their brain.  The METIS study will also evaluate the effects of SRS and TTFields on patients’ ability to think and remember.  This is evaluated through the use of neurocognitive testing throughout the study.  The METIS study is not blinded.

Sponsor: Novocure, Ltd

Principal Investigator: Melissa Lemieux, MD

Dignity Health

Clinical Trials Website: ClinicalTrials.Gov  


Lung Cancer

 ALCHEMIST

The ALCHEMIST group of studies are for patients with early stage NSCLC that has been completely resected (removed) by surgery.  These patients are normally initially treated with either chemotherapy, radiation therapy or both.  The ALCHEMIST screening study will evaluate some of the tumor removed during surgery to look for particular “markers” within the cells.  Depending on these markers, the patient will be provided with one of three different additional treatment options to be provided after their initial therapy.  The treatment options are all FDA approved in the setting of recurrence of their lung cancers.  ALCHEMIST hopes to show that recurrence can be prevented or delayed by providing these treatments early on.  Patients who prefer not to take part in the offered treatment study can remain on the screening study.  Each of the treatment studies is unblinded with half of the patients receiving the treatment.  The other half of the patients are followed by observation.  The ALCHEMIST group consists of the A151216, the E4512, the A081105 and the EA5142 studies.

Sponsor: NRB Oncology

Principal Investigator: Shahzad Siddique, MD

Dr Siddique

Clinical Trials Website:

A151216: ClinicalTrials.Gov  
A081105:ClinicalTrials.Gov  
E4512: ClinicalTrials.Gov  
EA5142: ClinicalTrials.Gov  

LUNAR

The LUNAR study is for patients with Stage 4 NSCLC who have failed treatment with a platinum containing chemotherapy.  All patients will receive treatment for their lung cancer with either Taxotere or an immunotherapy medication.  This decision will be made by your physician and is based upon the characteristics of your cancer.  In addition to this treatment, half of the patients will receive therapy with Tumor Treating Fields (TTFields).  The other half of the patients receive no TTFields therapy.  The study hopes to show that patients do better overall with the addition of the TTFields.  The LUNAR study is not blinded.

Sponsor: Novocure, Ltd

Principal Investigator: Sonia Reichert, MD

Dr Reichert

Clinical Trials Website: ClinicalTrials.Gov  


Pancreatic Cancer

Opening soon:  PANOVA-3

The PANOVA-3 study is for patients with locally advanced pancreatic cancer.  All patients will receive treatment with Abraxane and Gemzar.  Abraxane and Gemzar are chemotherapy medications given by IV infusion.  In addition to this treatment, half of the patients will receive therapy with Tumor Treating Fields (TTFields).  The other half of the patients receive no TTFields therapy.  The study hopes to show that patients do better overall with the addition of the TTFields.  The PANOVA-3 study is not blinded. 

Sponsor: Novocure, Ltd

Principal Investigator:  Samer Shihabi, MD

dignity health

Clinical Trials Website: ClinicalTrials.Gov   

 

Blood Cancer Registries

Miraca

The Miraca Registry is for patients who have been diagnosed with a blood cancer after having a bone marrow biopsy using the Miraca test kit.  The Registry collects information from these patients about their treatments, lab tests, side effects and disease state.  Miraca hopes to learn more about the best ways to diagnose, treat and manage patients with blood cancers.

Sponsor: Miraca Life Sciences

Principal Investigator: Gurvinder Shaheed, MD

Dr Gurvinder

This study is not listed on the ClinicalTrials.gov website

Connect MDS-AML

The Connect MDS-AML Registry is for patients who have been diagnosed with either MDS or AML.  The Registry collects information from these patient about their treatments, lab tests, side effects and disease state.  Connect MDS-AML hopes to learn more about the best ways to diagnose, treat and manage patients who have MDS or AML.

Sponsor: Celgene

Principal Investigator: Shahzad Siddique, MD

Dr Siddique

This study is not listed on the ClinicalTrials.gov website