Patients with surgically resectable T1N1M0 or T2-4N any M0 esophageal carcinoma will receive
six weeks of induction chemotherapy with weekly irinotecan and cisplatin given weeks 1, 2, 4
and 5. Patients will then receive weekly irinotecan, cisplatin, and concurrent radiotherapy
with chemotherapy given once weekly, weeks 8,9,11 and 12 during the six weeks of
radiotherapy. Patients will be referred for surgery 4-8 weeks after completion of
- Patients must be able to sign the informed consent document.
- Tis (in-situ carcinoma) and tumors determined to be TIN0 following endoscopy,
endoscopic ultrasound, or CT scanning.
- Cervical esophageal tumors,
- Gastric cancers with minor involvement of the gastroesophageal junction or distal
- Prior chemotherapy or radiation.
- Patients with evidence of metastatic disease are not eligible. This includes:
- Positive malignant cytology of the pleura, pericardium or peritoneum.
- Radiographic evidence of distant organ involvement including lung, liver, bone, or
- Patients with involvement of non-regional lymph nodes including supraclavicular or
celiac lymph node metastases.
- Biopsy proven tumor invasion of the tracheobronchial tree or presence of
tracheoesophageal fistula. Recurrent laryngeal nerve or phrenic nerve paralysis,
- New York Heart Association Class III or 1V heart disease. Angina or myocardial
infarction within the last 6 months, history of significant ventricular arrhythmia
requiring medication with antiarrhythmics, or a history of a clinically significant
conduction system abnormality.
- Severe co-morbid conditions including severe uncontrolled diabetes, uncontrolled
hypertension, cerebral vascular disease, uncontrolled infection, or nonmalignant
illness whose control may be jeopardized by the complications of this study
- Pregnant or lactating women are ineligible as the effect of the drugs used in this
study on a fetus or newborn child are unknown. Premenopausal fertile females require
a negative pregnancy test prior to study entry. Treatment may not begin until the
results of the pregnancy tests are ascertained. Both sexes must use contraception
while on this study.
- History of prior malignancy (other than basal cell/squamous carcinoma of the skin,
in-situ cervical carcinoma, or superficial transitional cell bladder carcinoma)
diagnosed and/or treated within three years of entrance into this study.
- Patients with known Gilbert's Disease.
- Clinically significant hearing loss.
- Serum calcium_>12 mg/dl.
- Patients with a history of seizure disorder who are receiving phenytoin,
phenobarbital, or other antiepileptic medication.
- Patients who cannot fully comprehend the therapeutic implications of the protocol or
comply with the requirements.
- Patients with any other concurrent medical or psychiatric condition or disease,
which, in the investigator's judgment, would make the patient inappropriate for entry
into this study.