Preoperative Combined Modality Therapy for Esophageal Carcinoma: Cisplatin-Irinotecan Followed by Radiation Therapy With Concurrent Cisplatin and Irinotecan.
- 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.