FOLFOX-6 Induction Chemotherapy Followed by Esophagectomy and Post-operative Chemoradiotherapy in… (NCT02037048) | Clinical Trial Compass
UnknownPhase 2
FOLFOX-6 Induction Chemotherapy Followed by Esophagectomy and Post-operative Chemoradiotherapy in Patients With Esophageal Adenocarcinoma
United States63 participantsStarted 2014-02-10
Plain-language summary
This phase II trial studies how well oxaliplatin, leucovorin calcium, and fluorouracil followed by surgery and response based concurrent chemotherapy and radiation therapy works in treating patients with cancer of the esophagus, gastroesophageal junction, or gastric cardia. Drugs used in chemotherapy, such as oxaliplatin, leucovorin calcium, fluorouracil, paclitaxel, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high energy x rays to kill tumor cells. Giving chemotherapy followed by surgery and response based chemotherapy and radiation therapy may kill more tumor cells.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients must have a histologic diagnosis of adenocarcinoma of the esophagus, GEJ, or GC based on biopsy material or adequate cytologic exam; tumors of the GC are defined as originating within 5 cm of the GEJ
* Patients must be clinically staged according to the 7th edition (2010) of the American Joint Committee on Cancer (AJCC) staging system and must have either clinical T3-4a, or ≥ N1 disease; staging should include upper endoscopy with endoscopic ultrasound and a fludeoxyglucose (FDG)-positron emission tomography (PET)/computed tomography (CT) scan (with diagnostic CT abdomen/pelvis preferred)
* Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
* Absolute neutrophil count ≥ 1,500/ul
* Platelet count ≥100,000/ul
* Serum creatinine (Scr) ≤ 1.5mg/dl; if the Scr \> 1.5, patients may still be eligible if the calculated glomerular filtration rate (GFR) (Cockroft-Gault) is ≥ 40ml/minute
* Serum total bilirubin ≤ 1.5X the institutional upper limit of normal (ULN)
* Alkaline phosphatase ≤ 3X the institutional ULN
* Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 3X the institutional ULN
* Patients with Gilbert's syndrome are eligible provided the total bilirubin is ≤ 3 and the remainder of the liver function tests (ALT, AST, alkaline phosphatase \[ALK Phos\]) are within the institutional normal range
* Patients must have a forced expiratory volume in one second (FEV-1) and diffusing capacity of the lu…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial uses a three-part treatment sequence — FOLFOX-6 chemotherapy first, then surgery, then chemoradiation after surgery — how does that approach compare to what would typically be recommended for my stage of esophageal or gastroesophageal junction cancer today?
2Since this is a Phase 2 trial measuring recurrence-free survival compared to historical averages rather than against a control group of patients treated right now, what does that mean for how confident we can be about whether this sequence actually works better than standard options?
3The trial's recruitment status is listed as unknown — is this study still actively enrolling patients, and if it has closed or paused, does that affect whether its results or approach might still be relevant to my treatment planning?
4FOLFOX-6 is a multi-drug chemotherapy regimen — given my overall health and the fact that surgery is also part of this plan, what are the main risks or side effects I should understand before considering whether this kind of intensive combined approach is right for me?
5Are there currently approved or more established treatment options for Stage III esophageal adenocarcinoma that my care team would recommend I consider alongside or before exploring a trial like this one?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Recurrence Free Survival (RFS) compared to historical averages