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NRG-CC015: Harnessing E-Mindfulness Approaches for Living After Breast Cancer (HEAL-ABC)

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NCT#:NCT06748222
NCT QR Code
Title:Harnessing E-Mindfulness Approaches for Living After Breast Cancer (HEAL-ABC)
Protocol:NRG-CC015
Cancer Type: non-metastatic breast cancer which is Stage 0, I, II, or III
Study Sponsor: National Cancer Institute (NCI)
Brief Summary:  NRG-CC015 is a prospective, randomized phase III clinical trial to evaluate the efficacy of two distinct digital approaches for delivering a mindfulness-based intervention: a live, instructor-led version delivered over Zoom (MAPs LO), and an app-based, self-paced version (MAPs App). Participants will include younger breast cancer survivors (BCS) who were diagnosed with breast cancer at or before age 50 years, have completed their primary cancer treatment (i.e., surgery, radiation, and/or chemotherapy) at least 6 months earlier, and report elevated depressive symptoms.
Study Type: Interventional
Date Opened at SVMHS:  June 30, 2025
Recruitment Status:  Recruiting
Study Population:  18 Years to 50 Years (Adult )
Eligibility Criteria: The participant or a legally authorized representative must provide study-specific informed consent prior to pre-entry and, for participants treated in the U.S., authorization permitting release of personal health information.
The participant must have been greater than or equal to 18 or less than or equal to 50 years of age at the time of breast cancer diagnosis.
The participant must have a first-time diagnosis of non-metastatic breast cancer which is Stage 0, I, II, or III.
The participant must have a score of greater than or equal to 5 and less than or equal to 14 on the Patient Health Questionnaire-8 item (PHQ-8).
Participants must have completed all primary breast cancer treatments at least 6 months prior to and no more than 5 years prior to registration. Note: Primary treatments include surgery, radiation therapy, adjuvant chemotherapy, targeted therapies (e.g., PARP (poly-ADP ribose polymerase) inhibitors, CDK4/6 inhibitors, TDM-1, pertuzumab, or immunotherapy). (Participants may still be taking adjuvant therapy with trastuzumab or adjuvant endocrine therapy or completing minor reconstructive surgery.)
Participant must be able to understand, speak, read, and write in English or Spanish.
Participant must be willing to participate in a 6-week program to receive training in mindfulness.
Participant must be able to use a smartphone, tablet, or other digital device.
Sex assigned at birth must be female.
Principal Investigator:  Hong Zhao, MD, Oncology, Salinas Valley Health Cancer Care, (831) 755-1701
Participating Institution:  Salinas Valley Memorial Healthcare System & Salinas Valley Medical Clinics & Salinas Valley Memorial Hospital
SVMHS Clinical Research Program:  Terri Nielsen, MSJ, RN, CCRP, Clinical Research Program Manager, tnielsen2@svmh.com
Link to ClinicalTrials.gov:  https://clinicaltrials.gov/study/NCT06748222?cond=HEAL-ABC&rank=2#study-overview
SCHEMA:Schema
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National Cancer Institute “Cancer Moonshot Biobank”

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NCT#:NCT04314401
NCT QR Code
Title:National Cancer Institute “Cancer Moonshot Biobank”
Protocol:Moonshot
Cancer Type: Multiple cancer types:
Colorectal cancer: Stage IV;
Non-small cell or small cell lung cancer: Stage III/IV;
Prostate cancer: metastatic prostate cancer;
Gastric cancer, NOS: Stage IV;
Esophageal cancer, NOS: Stage IV;
Adenocarcinoma of gastroesophageal junction: Stage IV;
High Grade Serous ovarian cancer: Stage III/IV;
Invasive breast carcinoma: Stage III/IV;
Melanoma: Stage III/IV;
Acute myeloid leukemia;
Multiple myeloma.
Study Sponsor: National Cancer Institute (NCI)
Brief Summary:  This trial collects multiple tissue and blood samples, along with medical information, from cancer patients. The “Cancer Moonshot Biobank” is a longitudinal study. This means it collects and stores samples and information over time, throughout the course of a patient’s cancer treatment. By looking at samples and information collected from the same people over time, researchers hope to better understand how cancer changes over time and over the course of medical treatments.
Study Type: Observational
Date Opened at SVMHS:  January 24, 2025
Recruitment Status:  Recruiting
Study Population:   13 Years and older (Child,  Adult,  Older Adult)
Eligibility Criteria: Diagnosed with one of the following: Colorectal cancer: stage IV, Non-small cell or small cell lung cancer: stage III/IV, Prostate cancer: metastatic prostate cancer, Gastric cancer, not otherwise specified (NOS): stage IV, Esophageal cancer, NOS: stage IV, Adenocarcinoma of gastroesophageal junction: stage IV, High grade serous ovarian cancer: stage III/IV, Invasive breast carcinoma: stage III/IV, Melanoma: stage III/IV, Acute myeloid leukemia, Multiple myeloma
Principal Investigator:  Geetha N. Varma, MD, Oncology, Salinas Valley Health Cancer Care, (831) 755-1701
Participating Institution:  Salinas Valley Memorial Healthcare System & Salinas Valley Medical Clinics & Salinas Valley Memorial Hospital
SVMHS Clinical Research Program:  Terri Nielsen, MSJ, RN, CCRP, Clinical Research Program Manager, tnielsen2@svmh.com
Link to ClinicalTrials.gov:  https://clinicaltrials.gov/study/NCT04314401?cond=moonshot&rank=1#study-overview
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EA2183 – Testing the Addition of Radiotherapy to the Usual Treatment (Chemotherapy) for Patients With Esophageal and Gastric Cancer That Has Spread to a Limited Number of Other Places in the Body

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NCT#:NCT04248452
NCT QR Code
Title:Testing the Addition of Radiotherapy to the Usual Treatment (Chemotherapy) for Patients With Esophageal and Gastric Cancer That Has Spread to a Limited Number of Other Places in the Body
Protocol:EA2183
Cancer Type: Esophageal/Gastric
Study Sponsor: NCI / ECOG-ACRIN
Brief Summary:  This phase III trial studies how well the addition of radiotherapy to the usual treatment (chemotherapy) works compared to the usual treatment alone in treating patients with esophageal and gastric cancer that has spread to a limited number of other places in the body (oligometastatic disease). Radiotherapy uses high energy x-rays, gamma rays, or protons to kill tumor cells and shrink tumors. Drugs used in usual chemotherapy, such as leucovorin, 5-fluorouracil, oxaliplatin, and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Adding radiotherapy to the usual chemotherapy may work better compared to the usual chemotherapy alone in treating patients with esophageal and gastric cancer.
Study Type: Interventional
Date Opened at SVH:  2-Sep-2021
Recruitment Status:  Closed to Recruiting
Study Population:   
Eligibility Criteria: See Schema
Principal Investigator:  Hong Zhao, MD, Oncology, Salinas Valley Health Cancer Care, (831) 755-1701
Participating Institution:  Salinas Valley Health
Salinas Valley Health Clinical Research Program:  Terri Nielsen, MSJ, RN, CCRP, Clinical Research Program Manager,  Research@SalinasValleyHealth.com
Link to ClinicalTrials.gov:  https://clinicaltrials.gov/ct2/show/record/NCT04248452?term=EA2183&draw=2&rank=1
Physician Fact Sheet:EA2183
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EA5182 – Osimertinib With or Without Bevacizumab as Initial Treatment for Patients With EGFR-Mutant Lung Cancer

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NCT#:NCT04181060
NCT QR Code
Title:Osimertinib With or Without Bevacizumab as Initial Treatment for Patients With EGFR-Mutant Lung Cancer
Protocol:EA5182
Cancer Type: Lung
Study Sponsor: NCI / ECOG-ACRIN
Brief Summary:  This phase III trial compares the effect of bevacizumab and osimertinib combination vs. osimertinib alone for the treatment of non-small cell lung cancer that has spread outside of the lungs (stage IIIB-IV) and has a change (mutation) in a gene called EGFR. The EGFR protein is involved in cell signaling pathways that control cell division and survival. Sometimes, mutations in the EGFR gene cause EGFR proteins to be made in higher than normal amounts on some types of cancer cells. This causes cancer cells to divide more rapidly. Osimertinib may stop the growth of tumor cells by blocking EGFR that is needed for cell growth in this type of cancer. Monoclonal antibodies, such as bevacizumab, may interfere with the ability of tumor cells to grow and spread. Giving osimertinib with bevacizumab may control cancer for longer and help patients live longer as compared to osimertinib alone.
Study Type: Interventional
Date Opened at SVH:  2-Sep-2021
Recruitment Status:  Closed
Study Population:   
Eligibility Criteria: See SCHEMA
Principal Investigator:  Hong Zhao, MD, Oncology, SVMC Cancer Care, (831) 755-1701
Participating Institution:  Salinas Valley Memorial Healthcare System & Salinas Valley Medical Clinics & Salinas Valley Memorial Hospital
SVH Clinical Research Program:  Terri Nielsen, MSJ, RN, CCRP, Clinical Research Program Manager,  Research@SalinasValleyHealth.com
Link to ClinicalTrials.gov:  https://clinicaltrials.gov/ct2/show/record/NCT04181060?term=EA5182&draw=2&rank=1
Physician Fact Sheet:EA5182
SCHEMA
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Doxorubicin Hydrochloride and Cyclophosphamide Followed by Paclitaxel With or Without Carboplatin in Treating Patients With Triple-Negative Breast Cancer

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NCT#:NCT02488967
NCT QR Code
Title:Doxorubicin Hydrochloride and Cyclophosphamide Followed by Paclitaxel With or Without Carboplatin in Treating Patients With Triple-Negative Breast Cancer
Protocol:NRG-BR003
Cancer Type: Breast
Study Sponsor: NCI / ECOG-ACRIN
Brief Summary:  This randomized phase III trial studies how well doxorubicin hydrochloride and cyclophosphamide followed by paclitaxel with or without carboplatin work in treating patients with triple-negative breast cancer. Drugs used in chemotherapy, such as doxorubicin hydrochloride, cyclophosphamide, paclitaxel, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether doxorubicin hydrochloride and cyclophosphamide is more effective when followed by paclitaxel alone or paclitaxel and carboplatin in treating triple-negative breast cancer.
Study Type: Interventional
Date Opened at SVMHS:  28-Jan-2016
Recruitment Status:  Closed
Study Population:   
Eligibility Criteria: The tumor must be unilateral invasive adenocarcinoma of the breast on histologic examination
Principal Investigator:  Hong Zhao, MD, Oncology, SVMC Cancer Care, (831) 755-1701
Participating Institution:  Salinas Valley Memorial Healthcare System & Salinas Valley Medical Clinics & Salinas Valley Memorial Hospital
SVMHS Clinical Research Program:  Terri Nielsen, MSJ, RN, CCRP, Clinical Research Program Manager, tnielsen2@svmh.com
Link to ClinicalTrials.gov:  https://clinicaltrials.gov/ct2/show/record/NCT02488967?term=NRG-BR003&draw=2&rank=1