sFOLFOXIRI in Advanced Gastroesophageal Cancer, (SAGE)
ConditionGastro-Intestinal Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorRutgers, The State University of New Jersey
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Four week alternating FOLFOX and FOLFIRI (sFOLFOXIRI)
Treatment groups
38 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov