Loyola University Medical Center

Gottlieb Memorial Hospital

MacNeal Hospital

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NCT00086996

S0356 Oxaliplatin, 5-FU, Radiation Therapy (RT), Surgery for Pts With Stage II or III Cancer of Esophagus or Gastroesophageal (GE) Junction

Official Title:

Oxaliplatin (NSC-266046) Plus Protracted Infusion 5-Fluorouracil And Radiation For Potentially Curable Esophageal Cancer: A Phase II Trial With Molecular Correlates

Summary

RATIONALE: Drugs used in chemotherapy, such as oxaliplatin and fluorouracil, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Oxaliplatin and fluorouracil may make tumor cells more sensitive to radiation therapy and may kill more tumor cells. Giving chemotherapy and radiation therapy before surgery may shrink the tumor so that it can be removed.

PURPOSE: This phase II trial is studying how well giving oxaliplatin together with fluorouracil and radiation therapy works in treating patients who are undergoing surgery for stage II or stage III cancer of the esophagus or gastroesophageal junction.

Eligibility

DISEASE CHARACTERISTICS:

* Histologically confirmed primary adenocarcinoma of the thoracic esophagus or gastroesophageal junction

* No recurrent disease
* Primary esophageal tumor at least 20 cm below the incisors (if \< 26 cm below the incisors, a bronchoscopy must be performed and cytology must be negative)
* Esophageal disease confined to esophagus and peri-esophageal soft tissue
* Gastroesophageal junction disease extending ≤ 2 cm into the gastric cardia
* Clinical stage II or III disease by CT scan or MRI

* If no esophageal mass is detected by these methods, esophageal endoscopic ultrasound is required to determine stage
* Positron-emission tomography scan is required to confirm stage
* Measurable or non-measurable disease by x-ray, scanning, or physical examination
* No celiac axis nodes ≥ 1.5 cm

* Measurable regional lymph nodes ≥ 1.5 cm at stations 2-10=N1 OR subdiaphragmatic lymph nodes at stations 15-19 ≤ 1.5 cm by CT scan or MRI allowed
* Palpable supraclavicular lymph nodes must be free of metastatic esophageal cancer by biopsy

PATIENT CHARACTERISTICS:

Age

* Over 18

Performance status

* Zubrod 0-2

Life expectancy

* Not specified

Hematopoietic

* Absolute neutrophil count ≥ 1,500/mm\^3
* White blood cell (WBC) count ≥ 3,000/mm\^3
* Hemoglobin ≥ 10.0 g/dL (transfusion allowed)

Hepatic

* Albumin ≥ 3 g/dL
* Bilirubin normal

Renal

* Creatinine ≤ 1.5 times upper limit of normal

Cardiovascular

* No myocardial infarction or cerebrovascular event within the past 6 months

Pulmonary

* No active pneumonia or inflammatory lung infiltrate

Other

* No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
* No peripheral neuropathy ≥ grade 2
* Not pregnant or nursing
* Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Not specified

Chemotherapy

* No prior chemotherapy for esophageal cancer

Endocrine therapy

* Not specified

Radiotherapy

* No prior radiotherapy for esophageal cancer
* No concurrent intensity-modulated radiotherapy

Surgery

* No prior surgical resection or attempted surgical resection of esophageal cancer

Disease(s) and\or Condition(s)

Esophageal Cancer

Primary Purpose
  • TREATMENT
Intervention/Treatment
    • Type: DRUG
    • Name: fluorouracil
    • Description: Before surgery: 180 mg/m2/day by 24-hour infusion days 8 through 43. After surgery:180 mg/m2/day by 24-hour infusion days 1 through 36.
    • Arm Group Labels: Chemo Plus RT, Surgery, Chemo
    • Type: DRUG
    • Name: oxaliplatin
    • Description: Before surgery: 85 mg/m2 by 2-hour IV infusion days 1, 15, and 29. After surgery: 85 mg/m2 by 2-hour IV infusion days 1, 15, and 29.
    • Arm Group Labels: Chemo Plus RT, Surgery, Chemo
    • Type: PROCEDURE
    • Name: conventional surgery
    • Description: The surgical technique will depend upon the location and extent of tumor and individual surgeon preference.
    • Arm Group Labels: Chemo Plus RT, Surgery, Chemo
    • Type: RADIATION
    • Name: radiation therapy
    • Description: Starting Day 8, patients will be treated 5 days/week at 180 centigray (cGy)/day times 25 fractions to a total dose of 4,500 cGy.
    • Arm Group Labels: Chemo Plus RT, Surgery, Chemo
Sponsor
  • SWOG Cancer Research Network