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โ† Trials
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sFOLFOXIRI in Advanced Gastroesophageal Cancer, (SAGE)

RecruitingPhase 2Ages 18 Years - anyAllRutgers, The State University of New Jersey
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In plain words

What the trial is, and whether it could suit you

The primary objective is to determine the clinical efficacy of treatment regimen in terms of objective response rate (ORR). The secondary objectives is to determine the clinical efficacy of the study treatment in terms of progression free survival (PFS) and overall survival (OS). Additionally, to characterize the safety and toxicity profile of the study treatment as measured by the adverse event rates.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Histologically and/or cytologically confirmed metastatic or unresectable adenocarcinoma of esophageal, gastroesophageal junction or gastric origin * Tumor is HER2 negative by standard local testing methodology * Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 - 2 * Measurable disease by response evaluation criteria in solid tumors (RECIST) v1.1 * No prior systemic therapy for the present cancer given in the metastatic setting and \> 6 months from administration of peri-operative chemotherapy, if applicable o Note: up to two prior cycles of mFOLFOX6 for the present illness is permitted if patients otherwise qualify for the study with adequate baseline imaging * At least 18 years of age * Adequate bone marrow and organ functions as defined by: * Absolute neutrophil count โ‰ฅ 1500 cells/ ฮผL * Hemoglobin โ‰ฅ 8 g/ dL * Platelets \> 100,000 / ฮผL * Creatinine โ‰ค 1.5 x upper limit of normal (ULN) OR creatinine clearance โ‰ฅ 30 mL/min by Cockroft-Gault * Total bilirubin โ‰ค ULN * Aspartate aminotransferase (AST)/ Alanine aminotransferase (ALT) \< 2.5 x ULN, unless with liver metastases and then must be \<5 x ULN of normal * Women and men of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect pregnancy on study, she must notify her treating physician immediately. * Ability to understand the nature of this study protocol and give written informed consent. * Willingness and ability to comply with scheduled visits, treatment plans laboratory tests and other study procedures. Exclusion Criteria: * Receipt of any investigational agents at the time of registration * Known, untreated brain metastases * Grade two or greater peripheral neuropathy * Presence of any additional active malignancy within the past three years where the malignancy is at least reasonably likely to later the course of therapy, require systemic therapy or interfere with imaging assessments * For those patients who are going to receive nivolumab * No active use of systemic corticosteroids at the time of enrollment, at a dose equivalent of 10 mg/day or prednisone * Clinically significant autoimmune disease which is active or has required systemic immunosuppression within the last two years * Prior organ transplant or bone marrow transplant * History of interstitial lung disease or pneumonitis * Uncontrolled intercurrent illness, including significant active infection, symptomatic congestive heart failure, unstable angina or active arrhythmia * Major surgery within the four weeks prior to initiation of study treatment * A history of allergy or hypersensitivity to any of the study drugs * Any additional significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from fully participating in the study
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What it tests

  • Four week alternating FOLFOX and FOLFIRI (sFOLFOXIRI)
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Where

6 sites
RWJBarnabas Health - Robert Wood Johnson University Hospital
Hamilton, United States
RWJBarnabas Health - Monmouth Medical Center Southern Campus
Lakewood, United States
RWJBarnabas Health - Monmouth Medical Center
Long Branch, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, United States
RWJBarnabas Health - Robert Wood Johnson University Hospital, Somerset
New Brunswick, United States
RWJBarnabas Health - Newark Beth Israel Medical Center
Newark, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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