- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05332002
sFOLFOXIRI in Advanced Gastroesophageal Cancer, (SAGE)
A Phase II Study of sFOLFOXIRI in Advanced Gastroesophageal Cancer (SAGE)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Patrick Boland, MD
- Phone Number: (732)235-2465
- Email: pb564@cinj.rutgers.edu
Study Locations
-
-
New Jersey
-
Hamilton, New Jersey, United States, 08690
- Recruiting
- RWJBarnabas Health - Robert Wood Johnson University Hospital
-
Contact:
- Patrick Boland, MD
-
Lakewood, New Jersey, United States, 08701
- Recruiting
- RWJBarnabas Health - Monmouth Medical Center Southern Campus
-
Contact:
- Patrick Boland, MD
-
Long Branch, New Jersey, United States, 07740
- Recruiting
- RWJBarnabas Health - Monmouth Medical Center
-
Contact:
- Patrick Boland, MD
-
New Brunswick, New Jersey, United States, 08903
- Recruiting
- Rutgers Cancer Institute of New Jersey
-
Contact:
- Patrick Boland, MD
-
New Brunswick, New Jersey, United States, 08903
- Recruiting
- RWJBarnabas Health - Robert Wood Johnson University Hospital, Somerset
-
Contact:
- Patrick Boland, MD
-
Newark, New Jersey, United States, 07112
- Recruiting
- RWJBarnabas Health - Newark Beth Israel Medical Center
-
Contact:
- Patrick Boland, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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 ≥ 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.
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: 4week alternating FOLFOX and a combination chemotherapy regime FOLFIRI (sFOLFOXIRI),
A cycle will constitute 28 days of treatment, which will consist of one chemotherapy combination, either FOLFOX or FOLFIRI as below:
|
This is a Single Arm Phase II trial of q4week alternating FOLFOX and FOLFIRI (sFOLFOXIRI), with or without nivolumab, in advanced human epidermal growth factor receptor 2 (HER2) negative gastric and esophageal cancers (GEC). The study treatment is a chemotherapy combination of either FOLFOX or FOLFIRI as below:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Objective Response Rate (ORR) as measured by Response Evaluation Criteria in Solid Tumors ( RECIST) criteria version 1.1
Time Frame: Three Years
|
To determine the clinical efficacy of treatment regimen in terms of objective response rate.
|
Three Years
|
Progression Free Survival (PFS)
Time Frame: Three Years
|
To determine the clinical efficacy of the study treatment in terms of progressive free survival.
|
Three Years
|
Overall Survival (OS)
Time Frame: Three Years
|
To determine the clinical efficacy of the study treatment in terms of overall survival.
|
Three Years
|
Adverse Event Rates
Time Frame: Three Years
|
Three Years
|
Collaborators and Investigators
Investigators
- Principal Investigator: Patrick Boland, MD, Rutgers Cancer Institute of New Jersey
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 072204
- Pro2022000268 (Other Identifier: Rutgers Cancer Institute of New Jersey)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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