Epirubicin, Oxaliplatin and Fluorouracil (EOF) in Cancer of the Esophagus, Gastroesophageal Junct… (NCT00601705) | Clinical Trial Compass
CompletedPhase 2
Epirubicin, Oxaliplatin and Fluorouracil (EOF) in Cancer of the Esophagus, Gastroesophageal Junction, or Stomach
United States61 participantsStarted 2008-01-05
Plain-language summary
RATIONALE: Drugs used in chemotherapy, such as epirubicin, oxaliplatin, fluorouracil, and cisplatin, 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 before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving chemotherapy and radiation therapy after surgery may kill any tumor cells that remain after surgery.
PURPOSE: This phase II trial is studying how well giving combination chemotherapy, surgery, and radiation therapy works in treating patients with locoregionally advanced cancer of the esophagus, gastroesophageal junction, or stomach.
Who can participate
Age range18 Years
SexALL
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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, gastroesophageal junction or gastric cardia, based on biopsy material or adequate cytologic exam.
* Patients must be clinically staged according to the AJCC 2002 staging system and must have either T3-4, or N1 or M1a disease. Staging should include at least an upper endoscopy with endoscopic ultrasound and an FDG-PET/CT scan.
* Patients must have an ECOG performance status of 0-1.
* Patients must have adequate bone marrow function as evidenced by: Absolute neutrophil count \> 1,500/uL Platelet count \> 100,000/uL
* Patients must have adequate renal function as evidenced by serum creatinine \< 1.6 mg/dL
* Patients must have adequate hepatic function as evidenced by:Serum total bilirubin \< 1.5 mg/dL Alkaline phosphatase \< 3X the institutional ULN AST/ALT \< 3X the institutional ULN
* Patients must have adequate pulmonary function as evidenced by an FEV1 \> 50% predicted.
* Patients or their legal representatives must be able to read, understand, provide and sign informed consent to participate in the trial.
* Patients of childbearing potential agree to use an effective form of contraception during the study and for 90 days following the last dose of study medication (an effective form of contraception is an oral contraceptive or a double barrier method)
* Age \> 18 years
Exclusion Criteria:
* Patients with any other diagnosis except for adenocarcinoma (squamous cell carcinom…
What they're measuring
1
Feasibility of Induction Chemoradiotherapy as Measured by Resectability Rate