Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Esophageal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00005638
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : June 19, 2013
National Cancer Institute (NCI)
Information provided by:
Memorial Sloan Kettering Cancer Center

Brief Summary:

RATIONALE: Drugs used in chemotherapy use 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. Combining chemotherapy with radiation therapy may kill more tumor cells.

PURPOSE: Phase I trial to study the effectiveness of chemotherapy plus radiation therapy in treating patients who have advanced cancer of the esophagus.

Condition or disease Intervention/treatment Phase
Esophageal Cancer Gastric Cancer Drug: cisplatin Drug: irinotecan hydrochloride Radiation: radiation therapy Phase 1

Detailed Description:


  • Determine the dose limiting toxicity of irinotecan when given weekly with cisplatin and concurrent external beam multifield radiotherapy in patients with locally advanced carcinoma of the esophagus or gastroesophageal junction.
  • Determine the maximum tolerated dose and the recommended phase II dose of irinotecan in this regimen in this patient population.
  • Evaluate the complete response rate in these patients to one course of induction chemotherapy followed by concurrent chemotherapy and radiotherapy.

OUTLINE: This is a dose escalation study of irinotecan.

Patients receive induction chemotherapy with cisplatin IV over 30 minutes followed by irinotecan IV over 30 minutes on days 1, 8, 15, and 22. Following 2 weeks of rest, patients begin chemoradiation. Patients receive cisplatin and irinotecan as above on days 1, 8, 22, and 29 and radiotherapy once daily 5 days a week for 5-6 weeks.

Cohorts of 3-6 patients receive escalating doses of irinotecan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicities.

Patients are followed every 3 months for 2 years, every 6 months for 2 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 3-24 patients will be accrued for this study.

Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: Phase I Trial of Combined Modality Irinotecan, Cisplatin, and Concurrent Radiation Therapy for Patients With Locally Advanced Esophageal Cancer
Study Start Date : October 1999
Actual Primary Completion Date : April 2004
Actual Study Completion Date : April 2004

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed squamous cell carcinoma or adenocarcinoma of the esophagus or gastroesophageal junction

    • T1, N1, M0 or T2-4, Nx, M0

      • No supraclavicular or celiac lymph nodes
  • Previously untreated, newly diagnosed tumors OR
  • Prior resection without adjuvant therapy with local regional failure

    • Positive microscopic margin on resection of all gross disease allowed provided no metastatic disease
  • No positive malignant cytology of the pleura, pericardium, or peritoneum
  • No biopsy proven tumor invasion of the tracheobronchial tree or tracheoesophageal fistula



  • 18 and over

Performance status:

  • Karnofsky 70-100% OR
  • ECOG 0-2

Life expectancy:

  • Not specified


  • Absolute neutrophil count greater than 1,500/mm^3
  • Platelet count at least 100,000/mm^3
  • Hemoglobin at least 9.0 g/dL


  • Bilirubin no greater than 1.5 mg/dL
  • No known Gilbert's disease


  • Creatinine no greater than 1.5 mg/dL
  • No hypercalcemia


  • No New York Heart Association class III or IV heart disease
  • No myocardial infarction within the past 6 months
  • No uncontrolled hypertension


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No other severe concurrent conditions (e.g., severe uncontrolled diabetes, uncontrolled infections, or cerebral vascular disease)
  • No other malignancy within the past 5 years except basal cell carcinoma of the skin or carcinoma in situ of the cervix
  • No history of seizure disorder currently receiving phenytoin, phenobarbital, or other antiepileptic medication
  • No other concurrent medical or psychiatric condition or disease that would preclude study entry


Biologic therapy:

  • Not specified


  • No prior chemotherapy for esophageal cancer including adjuvant chemotherapy

Endocrine therapy:

  • Not specified


  • No prior radiotherapy for esophageal cancer including adjuvant radiotherapy
  • No prior mantle, chest, pelvic, or hemibody radiotherapy


  • See Disease Characteristics


  • No concurrent prochlorperazine on day of irinotecan administration

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00005638

United States, California
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States, 90033-0804
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
National Cancer Institute (NCI)
Study Chair: David H. Ilson, MD, PhD Memorial Sloan Kettering Cancer Center

Publications of Results: Identifier: NCT00005638     History of Changes
Other Study ID Numbers: 99-081
CDR0000067794 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: June 19, 2013
Last Verified: June 2013

Keywords provided by Memorial Sloan Kettering Cancer Center:
stage II gastric cancer
stage III gastric cancer
stage II esophageal cancer
stage III esophageal cancer
adenocarcinoma of the stomach
squamous cell carcinoma of the esophagus
adenocarcinoma of the esophagus

Additional relevant MeSH terms:
Stomach Neoplasms
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Head and Neck Neoplasms
Esophageal Diseases
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action