Category: Interventional

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NRG-BR009 – Evaluating the Addition of Adjuvant Chemotherapy to Ovarian Function Suppression Plus Endocrine Therapy in Premenopausal Patients With pN0-1, ER-Positive/​HER2-Negative Breast Cancer and an Oncotype Recurrence Score Less Than or Equal to 25 (OFSET)

NCT#:NCT05879926
NCT QR Code
Title:NRG-BR009 – Evaluating the Addition of Adjuvant Chemotherapy to Ovarian Function Suppression Plus Endocrine Therapy in Premenopausal Patients With pN0-1, ER-Positive/​HER2-Negative Breast Cancer and an Oncotype Recurrence Score Less Than or Equal to 25 (OFSET)
Protocol:NRG-BR009
Cancer Type:Breast
Study Sponsor:NRG Oncology
Brief Summary:This Phase III Trial will determine whether adjuvant chemotherapy (ACT) added to ovarian function suppression (OFS) plus endocrine therapy (ET) is superior to OFS plus ET in improving invasive breast cancer-free survival (IBCFS) among premenopausal, early- stage breast cancer (EBC) patients with estrogen receptor (ER)-positive, HER2-negative tumors and 21-gene recurrence score (RS) between 16-25 (for pN0 patients) and 0-25 (for pN1 patients).
Study Type:Intervention
Date Opened at SVH:March 12, 2024
Recruitment Status:Recruiting
Study Population:See SCHEMA
Eligibility Criteria:See SCHEMA
Principal Investigators:Geetha N. Varma, MD, Oncology, Salinas Valley Health Cancer Care, (831) 755-1701
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, [email protected]
Link to ClinicalTrials.govhttps://clinicaltrials.gov/study/NCT05879926?term=NCT05879926&limit=10&rank=1
SummarySee Physician Material
See Patient-facing Material
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Observational Basket Trial to Collect Tissue to Train and Validate a Live Tumor Diagnostic Platform (CYBRID-02)

NCT#:NCT05520099
NCT QR Code
Title:Observational Basket Trial to Collect Tissue to Train and Validate a Live Tumor Diagnostic Platform (CYBRID-02)
Protocol:CYBRID-02
Cancer Type:multiple
Study Sponsor:Elephas
Brief Summary:The primary objective of this study is to determine the ex-vivo prognostic accuracy of the Cybrid live tumor diagnostic platform across a basket of solid tumors, using in-vivo RECIST 1.1 as the reference method.
Study Type:Intervention/Treatment
Date Opened at SVH:February 21, 2024
Recruitment Status:Recruiting
Study Population:See SCHEMA
Eligibility Criteria:See SCHEMA
Principal Investigators:Geetha N. Varma, MD, Oncology, Salinas Valley Health Cancer Care, (831) 755-1701
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, [email protected]
Link to ClinicalTrials.govhttps://clinicaltrials.gov/study/NCT05520099?term=elephas%20cybrid&rank=2
SummarySee Patient-Facing Material
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S2212 – Shorter Anthracycline-Free Chemo Immunotherapy Adapted to Pathological Response in Early Triple Negative Breast Cancer (SCARLET), A Randomized Phase III Study

NCT#:NCT05929768
NCT QR Code
Title:Shorter Anthracycline-Free Chemo Immunotherapy Adapted to Pathological Response in Early Triple Negative Breast Cancer (SCARLET), A Randomized Phase III Study
Protocol:S2212
Cancer TypeBreast
Study Sponsor:SWOG Cancer Research Network
Brief Summary:This phase III trial compares the effects of shorter chemotherapy (chemo)-immunotherapy without anthracyclines to usual chemo-immunotherapy for the treatment of early-stage triple negative breast cancer. Paclitaxel is in a class of medications called anti-microtubule agents. It stops cancer cells from growing and dividing and may kill them. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of cancer cells. Cyclophosphamide is in a class of medications called alkylating agents. It works by damaging the cell’s deoxyribonucleic acid (DNA) and may kill cancer cells. It may also lower the body’s immune response. Docetaxel is in a class of medications called taxanes. It stops cancer cells from growing and dividing and may kill them. Doxorubicin is an anthracycline chemotherapy drug that damages DNA and may kill cancer cells. Pembrolizumab may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Shorter treatment without anthracycline chemotherapy may work the same as the usual anthracycline chemotherapy treatment for early-stage triple negative breast cancer.
Study Type:Interventional
Date Opened at SVH:February 7, 2024
Recruitment Status:Recruiting
Study Population:
Eligibility Criteria:See SCHEMA
Principal Investigator:Geetha N. Varma, 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, [email protected]
Link to ClinicalTrials.govhttps://classic.clinicaltrials.gov/ct2/show/NCT05812807?term=NCT05812807&draw=2&rank=1
SummarySummary
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A012103 – Pembrolizumab vs. Observation in People With Triple-negative Breast Cancer Who Had a Pathologic Complete Response After Chemotherapy Plus Pembrolizumab

NCT#:NCT05812807
NCT QR Code
Title:OptimICE-PCR: De-Escalation of Therapy in Early-Stage TNBC Patients Who Achieve pCR After Neoadjuvant Chemotherapy With Checkpoint Inhibitor Therapy
Protocol:A012103
Cancer TypeBreast
Study Sponsor:Alliance/NCI
Brief Summary:The phase III trial compares the effect of pembrolizumab to observation for the treatment of patients with early-stage triple-negative breast cancer who achieved a pathologic complete response after preoperative chemotherapy in combination with pembrolizumab. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. This trial may help researchers determine if observation will result in the same risk of cancer coming back as pembrolizumab after surgery in triple-negative breast cancer patients who achieve pathologic complete response after preoperative chemotherapy with pembrolizumab.
Study Type:Interventional
Date Opened at SVH:August 3, 2023
Recruitment Status:Recruiting
Study Population:
Eligibility Criteria:See SCHEMA
Principal Investigator:Geetha N. Varma, 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, [email protected]
Link to ClinicalTrials.govhttps://classic.clinicaltrials.gov/ct2/show/NCT05812807?term=NCT05812807&draw=2&rank=1
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NRG-GI008 – Colon Adjuvant Chemotherapy Based on Evaluation of Residual Disease (CIRCULATE-US)

NCT#:NCT05174169
NCT QR Code
Title:NRG-GI008 – Colon Adjuvant Chemotherapy Based on Evaluation of Residual Disease (CIRCULATE-US)
Protocol:NRG-GI008
Cancer Type: Colon Cancer
Study Sponsor: NRG Oncology
Brief Summary:  This Phase II/III trial will evaluate the what kind of chemotherapy to recommend to patients based on the presence or absences of circulating tumor DNA (ctDNA) after surgery for colon cancer.
Study Type: Interventional
Date Opened at SVH:  opening soon
Recruitment Status:  opening soon
Study Population:  
Eligibility Criteria: See SCHEMA
Principal Investigator:  Geetha N. Varma, 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, [email protected]
Link to ClinicalTrials.gov:  https://clinicaltrials.gov/ct2/show/study/NCT05174169
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A022104 – Testing the Addition of an Anti-Cancer Drug, Irinotecan, to the Standard Chemotherapy Treatment (FOLFOX) After Long-Course Radiation Therapy for Advanced-Stage Rectal Cancers to Improve the Rate of Complete Response and Long-Term Rates of Organ Preservation (JANUS)

NCT#:NCT05610163
NCT QR Code
Title:A022104 – Testing the Addition of an Anti-Cancer Drug, Irinotecan, to the Standard Chemotherapy Treatment (FOLFOX) After Long-Course Radiation Therapy for Advanced-Stage Rectal Cancers to Improve the Rate of Complete Response and Long-Term Rates of Organ Preservation (JANUS)
Protocol:A022104
Cancer Type: Rectal Cancer
Study Sponsor: Alliance/NCI
Brief Summary:  This phase II trial compares the effect of irinotecan versus oxaliplatin after long-course chemoradiation in patients with stage II-III rectal cancer. Combination chemotherapy drugs, such as FOLFIRINOX (fluorouracil, irinotecan, leucovorin, and oxaliplatin), FOLFOX (leucovorin, fluorouracil, oxaliplatin, and irinotecan ), and CAPOX (capecitabin and oxaliplatin) 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. FOLFOX or CAPOX are used after chemoradiation as usual treatment for rectal cancer. Giving FOLFIRINOX after chemoradiation may increase the response rate and lead to higher rates of clinical complete response (with a chance of avoiding surgery) compared to FOLFOX or CAPOX after chemoradiation in patients with locally advanced rectal cancer.
Study Type: Interventional
Date Opened at SVH:  February 15, 2022
Recruitment Status:  Recruiting
Study Population:  
Eligibility Criteria: See SCHEMA
Principal Investigator:  Geetha N. Varma, 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, [email protected]
Link to ClinicalTrials.gov:  https://clinicaltrials.gov/ct2/show/record/NCT05610163?term=A022104&draw=2&rank=1
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CCTG MA.39 – Regional Radiotherapy in Biomarker Low-Risk Node Positive and T3N0 Breast Cancer (TAILOR RT)

NCT#:NCT03488693
NCT QR Code
Title:Regional Radiotherapy in Biomarker Low-Risk Node Positive and T3N0 Breast Cancer (TAILOR RT)
Protocol:CCTG MA.39
Cancer Type:Breast
Study Sponsor:Canadian Cancer Trials Group
NCI CIRB
Brief Summary:The purpose of this study is to compare the effects on low risk breast cancer receiving usual care that includes regional radiation therapy, with receiving no regional radiation therapy. Researchers want to see if not giving this type of radiation treatment works as well at preventing breast cancer from coming back.
Study Type:Interventional  
Date Opened at SVH:May 6, 2022
Recruitment Status:Recruiting
Study Population:
Eligibility Criteria:See SCHEMA
Principal Investigator:Jacob Andrade MD PhD, Coastal Radiation Oncology Salinas, (831) 758-2724
Participating Institution:Salinas Valley Health
SVH Clinical Research Program:Terri Nielsen, MSJ, RN, CCRP, Clinical Research Program Manager, [email protected]
Link to ClinicaTrials.govhttps://clinicaltrials.gov/ct2/show/record/NCT03488693?term=CCTG+MA.3&draw=2&rank=1
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A082002 – Testing the Addition of Radiation Therapy to the Usual Treatment (Immunotherapy With or Without Chemotherapy) for Stage IV Non-Small Cell Lung Cancer Patients Who Are PD-L1 Negative

NCT#:NCT04929041
NCT QR Code
Title:A082002 – Testing the Addition of Radiation Therapy to the Usual Treatment (Immunotherapy With or Without Chemotherapy) for Stage IV Non-Small Cell Lung Cancer Patients Who Are PD-L1 Negative
Protocol:A082002
Cancer Type: Lung Cancer
Study Sponsor: Alliance/NCI
Brief Summary:  This phase II/III trial compares the addition of radiation therapy to the usual treatment (immunotherapy with or without chemotherapy) vs. usual treatment alone in treating patients with non-small cell lung cancer that has spread to nearby tissue or lymph nodes (advanced) or has spread to other places in the body (metastatic) whose tumor is also negative for a molecular marker called PD-L1. Stereotactic body radiation therapy (SBRT) is a type of radiation therapy that uses high energy x-rays to kill tumor cells and shrink tumors. This method uses special equipment to position a patient and precisely deliver radiation to tumors with fewer doses over a shorter period and may cause less damage to normal tissue than conventional radiation therapy. Immunotherapy with monoclonal antibodies, such as nivolumab, ipilimumab and pembrolizumab, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as carboplatin, pemetrexed, paclitaxel and nab-paclitaxel, 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. The addition of radiation therapy to usual treatment may stop the cancer from growing and increase the life of patients with advanced non-small cell lung cancer who are PD-L1 negative.
Study Type: Interventional
Date Opened at SVH:  April 14, 2022
Recruitment Status:  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
SVH Clinical Research Program:  Terri Nielsen, MSJ, RN, CCRP, Clinical Research Program Manager,  [email protected]
Link to ClinicalTrials.gov:  https://clinicaltrials.gov/ct2/show/record/NCT04929041?term=a082002&draw=2&rank=1
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A011801 – T-DM1 and Tucatinib Compared With T-DM1 Alone in Preventing Relapses in People With High Risk HER2-Positive Breast Cancer, the CompassHER2 RD Trial

NCT#NCT04457596
NCT QR Code
Title:T-DM1 and Tucatinib Compared With T-DM1 Alone in Preventing Relapses in People With High Risk HER2-Positive Breast Cancer, the CompassHER2 RD Trial
Protocol:A011801
Cancer Type:Breast
Study Sponsor:NCI /Alliance
Brief Summary:This phase III trial studies how well trastuzumab emtansine (T-DM1) and tucatinib work in preventing breast cancer from coming back (relapsing) in patients with high risk, HER2 positive breast cancer. T-DM1 is a monoclonal antibody, called trastuzumab, linked to a chemotherapy drug, called DM1. Trastuzumab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as HER2 receptors, and delivers DM1 to kill them. Tucatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving T-DM1 and tucatinib may work better in preventing breast cancer from relapsing in patients with HER2 positive breast cancer compared to T-DM1 alone.
Study Type:Interventional
Date Opened at SVH:4-Jan-2022
Recruitment Status: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
SVH Clinical Research Program:Terri Nielsen, MSJ, RN, CCRP, Clinical Research Program Manager,  [email protected]
Link to ClinicalTrials.gov:https://clinicaltrials.gov/ct2/show/record/NCT04457596?term=A011801&draw=2&rank=1
Schema & ProtocolA011801-Schema

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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

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:  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,  [email protected]
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

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:  Recruiting
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,  [email protected]
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

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, [email protected]
Link to ClinicalTrials.gov:  https://clinicaltrials.gov/ct2/show/record/NCT02488967?term=NRG-BR003&draw=2&rank=1