RECRUITING

sFOLFOXIRI in Advanced Gastroesophageal Cancer, (SAGE)

Conditions

Gastro-Intestinal Cancer Gastric and esophageal cancers (GEC)

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Phase II Study of sFOLFOXIRI in Advanced Gastroesophageal Cancer (SAGE)

Quick Facts

Study Start:2022-07-13

Study Completion:2025-08-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05332002

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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 * At least 18 years of age * Adequate bone marrow and organ functions as defined by: * Absolute neutrophil count ≥ 1500 cells/ μL * Hemoglobin ≥ 8 g/ dL * Platelets \> 100,000 / μL * Creatinine ≤ 1.5 x upper limit of normal (ULN) OR creatinine clearance ≥ 30 mL/min by Cockroft-Gault * Total bilirubin ≤ 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.	* 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

Inclusion Criteria

Exclusion 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
* At least 18 years of age
* Adequate bone marrow and organ functions as defined by:
* Absolute neutrophil count ≥ 1500 cells/ μL
* Hemoglobin ≥ 8 g/ dL
* Platelets \> 100,000 / μL
* Creatinine ≤ 1.5 x upper limit of normal (ULN) OR creatinine clearance ≥ 30 mL/min by Cockroft-Gault
* Total bilirubin ≤ 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.

* 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

Contacts and Locations

Study Contact

Patrick Boland, MD

CONTACT

(732)235-2465

pb564@cinj.rutgers.edu

Principal Investigator

Patrick Boland, MD

PRINCIPAL_INVESTIGATOR

Rutgers Cancer Institute of New Jersey

Study Locations (Sites)

RWJBarnabas Health - Robert Wood Johnson University Hospital

Hamilton, New Jersey, 08690

United States

RWJBarnabas Health - Monmouth Medical Center Southern Campus

Lakewood, New Jersey, 08701

United States

RWJBarnabas Health - Monmouth Medical Center

Long Branch, New Jersey, 07740

United States

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08903

United States

RWJBarnabas Health - Robert Wood Johnson University Hospital, Somerset

New Brunswick, New Jersey, 08903

United States

RWJBarnabas Health - Newark Beth Israel Medical Center

Newark, New Jersey, 07112

United States

Collaborators and Investigators

Sponsor: Rutgers, The State University of New Jersey

Patrick Boland, MD, PRINCIPAL_INVESTIGATOR, Rutgers Cancer Institute of New Jersey

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-07-13

Study Completion Date2025-08-01

Study Record Updates

Study Start Date2022-07-13

Study Completion Date2025-08-01

Terms related to this study

Keywords Provided by Researchers

Gastric and esophageal cancers (GEC)

Additional Relevant MeSH Terms

Gastro-Intestinal Cancer