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

Phase 2
18 Years
Not Enrolling
Esophageal Carcinoma

Thank you

Trial Information

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

Inclusion Criteria:

- Patients must be able to sign the informed consent document.

Exclusion Criteria:

- 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.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Determine pathologic complete response rate for subjects on study

Outcome Time Frame:

Conclusion of the study

Safety Issue:


Principal Investigator

David Ilson, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

November 2002

Completion Date:

December 2009

Related Keywords:

  • Esophageal Carcinoma
  • Esophageal Carcinoma
  • Cisplatin
  • Irinotecan
  • Radiation Therapy
  • 02-045
  • Carcinoma
  • Esophageal Diseases
  • Esophageal Neoplasms



Memorial Sloan Kettering Cancer Center New York, New York  10021