Gastro-Intestinal CancerPhase 2NCT05332002
sFOLFOXIRI in Advanced Gastroesophageal Cancer, (SAGE)
A Phase 2 study testing Four week alternating FOLFOX and FOLFIRI (sFOLFOXIRI) in people with Gastro-Intestinal Cancer, run by Rutgers, The State University of New Jersey at 6 sites in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastro-Intestinal Cancer
- What is being tested?
- Four week alternating FOLFOX and FOLFIRI (sFOLFOXIRI)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 6 sitesUnited States
- Study dates
- 13 Jul 2022to 1 Aug 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
United States6 sites, 6 recruiting
- Recruiting
RWJBarnabas Health - Robert Wood Johnson University Hospital
Hamilton, New Jersey, 08690
Patrick Boland, MD
- Recruiting
RWJBarnabas Health - Monmouth Medical Center Southern Campus
Lakewood, New Jersey, 08701
Patrick Boland, MD
- Recruiting
RWJBarnabas Health - Monmouth Medical Center
Long Branch, New Jersey, 07740
Patrick Boland, MD
- Recruiting
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903
Patrick Boland, MD
- Recruiting
RWJBarnabas Health - Robert Wood Johnson University Hospital, Somerset
New Brunswick, New Jersey, 08903
Patrick Boland, MD
- Recruiting
RWJBarnabas Health - Newark Beth Israel Medical Center
Newark, New Jersey, 07112
Patrick Boland, MD
About this study
Official title: A Phase II Study of sFOLFOXIRI in Advanced Gastroesophageal Cancer (SAGE)
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.
Read the detailed description
The overall purpose of this protocol is to serve as a Single Arm Phase II trial of a four week alternating FOLFOX and FOLFIRI (sFOLFOXIRI), with or without nivolumab, in advanced human epidermal growth factor receptor two (HER2) negative gastric and esophageal cancers (GEC). This study evaluates the hypothesis that the use of sFOLFOXIRI in gastroesophageal cancer (GEC) will increase response rates beyond that expected with FOLFOX, while maintaining acceptable tolerability. The primary endpoint of this study is the objective response rate (ORR) while the key secondary endpoints include the progression free survival (PFS), overall survival (OS), and adverse event (AE) rates. The goal of this study is to establish the activity level of sFOLFOXIRI, with the thought that this could be further developed in the metastatic and/or peri-operative space if a sufficiently interesting degree of efficacy is observed.
- Conditions
- Gastro-Intestinal Cancer
- Being tested
- Four week alternating FOLFOX and FOLFIRI (sFOLFOXIRI)
- Keywords
- Gastric and esophageal cancers (GEC)
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Four week alternating FOLFOX and FOLFIRI (sFOLFOXIRI)Drug
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:
- mFOLFOX6: (Oxaliplatin 85 mg/m2 IV, leucovorin 400 mg/m2, 5-FU 400 mg/m2 bolus, then 5-FU 2400 mg/m2:
- FOLFIRI: (Irinotecan 180 mg/m2 IV, leucovorin 400 mg/m2, 5-FU 400 mg/m2 bolus, then 5-FU 2400 mg/m2
- Nivolumab(Optional) The chemotherapy combination of FOLFOX and FOLFIRI is a FDA approved treatment for advanced bowel and gastric
| Study group | Role | What they receive |
|---|---|---|
| 4week alternating FOLFOX and a combination chemotherapy regime FOLFIRI (sFOLFOXIRI), | Other | A cycle will constitute 28 days of treatment, which will consist of one chemotherapy combination, either FOLFOX or FOLFIRI as below:
1. Odd Cycles (e.g. 1, 3, 5, etc…) - mFOLFOX6 initiated on days 1 \& 15: (Oxaliplatin 85 mg/m2 IV, leucovorin 400 mg/m2, 5FU 400 mg/m2 bolus, then 5FU 2400 mg/m2 over 46 hours)
2. Even Cycles (e.g. 2,4,6, etc…) - FOLFIRI initiated on days 1 \& 15: (Irinotecan 180 mg/m2 IV, leucovorin 400 mg/m2, 5FU 400 mg/m2 bolus, then 5FU 2400 mg/m2 over 46 hours)
3. Nivolumab (optional, in-line with labelled approval) - 240 mg every 2 weeks Receives: Drug: Four week alternating FOLFOX and FOLFIRI (sFOLFOXIRI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR) as measured by Response Evaluation Criteria in Solid Tumors ( RECIST) criteria version 1.1
To determine the clinical efficacy of treatment regimen in terms of objective response rate.
Measured: Three Years
Progression Free Survival (PFS)
To determine the clinical efficacy of the study treatment in terms of progressive free survival.
Measured: Three Years
Overall Survival (OS)
To determine the clinical efficacy of the study treatment in terms of overall survival.
Measured: Three Years
Adverse Event Rates
Measured: Three Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2022
- Study start13 Jul 2022
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastro-Intestinal CancerStudies of the same condition, open and under way.
- More trials run by Rutgers, The State University of New JerseyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patrick M Boland, MD, Rutgers, The State University of New Jersey
- Investigators
- Patrick Boland, MD, Principal investigator, Rutgers Cancer Institute of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05332002
- Sponsor's protocol ID
- 072204
- Other IDs
- Pro2022000268
- Status last verified
- Sep 2026
- First submitted
- 29 Mar 2022
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of sFOLFOXIRI in Advanced Gastroesophageal Cancer (SAGE)
- ClinicalTrials.gov ID
- NCT05332002
- Acronym / sponsor ID
- 072204
- Conditions
- Gastro-Intestinal Cancer
- Keywords
- Gastric and esophageal cancers (GEC)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Study start
- 13 Jul 2022 (actual)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 18 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The overall purpose of this protocol is to serve as a Single Arm Phase II trial of a four week alternating FOLFOX and FOLFIRI (sFOLFOXIRI), with or without nivolumab, in advanced human epidermal growth factor receptor two (HER2) negative gastric and esophageal cancers (GEC). This study evaluates the hypothesis that the use of sFOLFOXIRI in gastroesophageal cancer (GEC) will increase response rates beyond that expected with FOLFOX, while maintaining acceptable tolerability. The primary endpoint of this study is the objective response rate (ORR) while the key secondary endpoints include the progression free survival (PFS), overall survival (OS), and adverse event (AE) rates. The goal of this study is to establish the activity level of sFOLFOXIRI, with the thought that this could be further developed in the metastatic and/or peri-operative space if a sufficiently interesting degree of efficacy is observed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 4week alternating FOLFOX and a combination chemotherapy regime FOLFIRI (sFOLFOXIRI), | Other | Drug: Four week alternating FOLFOX and FOLFIRI (sFOLFOXIRI)A cycle will constitute 28 days of treatment, which will consist of one chemotherapy combination, either FOLFOX or FOLFIRI as below: 1. Odd Cycles (e.g. 1, 3, 5, etc…) - mFOLFOX6 initiated on days 1 \& 15: (Oxaliplatin 85 mg/m2 IV, leucovorin 400 mg/m2, 5FU 400 mg/m2 bolus, then 5FU 2400 mg/m2 over 46 hours) 2. Even Cycles (e.g. 2,4,6, etc…) - FOLFIRI initiated on days 1 \& 15: (Irinotecan 180 mg/m2 IV, leucovorin 400 mg/m2, 5FU 400 mg/m2 bolus, then 5FU 2400 mg/m2 over 46 hours) 3. Nivolumab (optional, in-line with labelled approval) - 240 mg every 2 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Four week alternating FOLFOX and FOLFIRI (sFOLFOXIRI)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: 1. mFOLFOX6: (Oxaliplatin 85 mg/m2 IV, leucovorin 400 mg/m2, 5-FU 400 mg/m2 bolus, then 5-FU 2400 mg/m2: 2. FOLFIRI: (Irinotecan 180 mg/m2 IV, leucovorin 400 mg/m2, 5-FU 400 mg/m2 bolus, then 5-FU 2400 mg/m2 3. Nivolumab(Optional) The chemotherapy combination of FOLFOX and FOLFIRI is a FDA approved treatment for advanced bowel and gastric | Drug | 4week alternating FOLFOX and a combination chemotherapy regime FOLFIRI (sFOLFOXIRI), |
Primary outcome
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.
Progression Free Survival (PFS)
Time frame: Three Years
To determine the clinical efficacy of the study treatment in terms of progressive free survival.
Overall Survival (OS)
Time frame: Three Years
To determine the clinical efficacy of the study treatment in terms of overall survival.
Adverse Event Rates
Time frame: Three Years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Patrick Boland, MD principal investigator
Rutgers Cancer Institute of New Jersey
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Four week alternating FOLFOX and FOLFIRI (sFOLFOXIRI) in people with Gastro-Intestinal Cancer, run by Rutgers, The State University of New Jersey at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Patrick Boland, MD ((732)235-2465, pb564@cinj.rutgers.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) as measured by Response Evaluation Criteria in Solid Tumors ( RECIST) criteria version 1.1 (time frame: Three Years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.