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New treatment option for Gastro-Intestinal Cancer
Official title sFOLFOXIRI in Advanced Gastroesophageal Cancer, (SAGE)
ClinicalTrials.gov ID: NCT05332002
What this study is testing
What is Four week alternating FOLFOX and FOLFIRI (sFOLFOXIRI)?
Four week alternating FOLFOX and FOLFIRI (sFOLFOXIRI) is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for gastro-intestinal cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
You likely can't join if
- 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...
- 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
See the full eligibility 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Hamilton, New Jersey, United States
- Lakewood, New Jersey, United States
- Long Branch, New Jersey, United States
- New Brunswick, New Jersey, United States
- Newark, New Jersey, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hamilton, New Jersey, United States; Lakewood, New Jersey, United States; Long Branch, New Jersey, United States; New Brunswick, New Jersey, United States; Newark, New Jersey, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.