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 range18 Years
SexALL
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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…
What they're measuring
1
Recurrence Free Survival (RFS) compared to historical averages