Pre-operative Chemotherapy and Radiation Therapy for Esophageal Carcinoma

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: NCT00230451
Recruitment Status : Completed
First Posted : September 30, 2005
Last Update Posted : January 15, 2010
Information provided by:
University of Michigan Cancer Center

Brief Summary:
Surgery (esophagectomy or removal of the esophagus)has been the standard treatment for cancer of the esophagus. However, evidence suggests that preoperative chemotherapy and radiation therapy may add benefit. The purpose of this study is to determine if a treatment program of combined chemotherapy and radiation therapy prior to surgery and chemotherapy after surgery will delay or eliminate recurrence of the cancer.

Condition or disease Intervention/treatment Phase
Esophageal Cancer Procedure: Radiation Drug: Paclitaxel Drug: Cisplatin Drug: 5-Fluorouracil Phase 2

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial of Preoperative Chemotherapy and Radiation Therapy Followed by Adjuvant Combination Chemotherapy for Patients With Loco-Regional Esophageal Carcinoma
Study Start Date : November 1997
Actual Primary Completion Date : December 1999
Actual Study Completion Date : July 2008

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. To determine the rate of complete histologic response induced by this neoadjuvant chemotherapy and radiation therapy regimen.

Secondary Outcome Measures :
  1. To determine the overall survival and time to relapse in patients treated with preoperative chemotherapy and radiation therapy followed by adjuvant combination chemotherapy.
  2. To assess the qualitative and quantitative toxicities of this regimen.

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Patient Eligibility:

  1. Histologically confirmed squamous cell carcinoma, adenocarcinoma, or mixed adeno/squamous of the the esophagus or gastroesophageal junction.
  2. Disease limited to the esophagus and regional lymph nodes. However, celiac node enlargement will be acceptable for tumors of the distal esophagus, because they will be included in the radiation field.
  3. Disease must be able to be encompassed in a single radiation field.
  4. No medical contraindication to surgery.
  5. All treatment is to be administered at the University of Michigan Medical Center
  6. Karnofsky Performance Status > 60%
  7. Ages 18-75
  8. Adequate renal function (BUN <1.5 x N; creatinine <1,5 mg/dl, or measured creatinine clearance>60 ml/min.).
  9. Adequate bone marrow reserve (WBC>3500/ul; Platelets>100,000/ul.).
  10. Adequate hepatic function (Bilirubin<1.5x N; AST <2 x upper limit of normal).
  11. Prior malignancy is acceptable if the patient is considered to be cured. In most cases this will mean a 5 year disease-free period.
  12. Ability to give informed consent.

Exclusion Criteria:

  1. Patients with active infection, pregnancy, lactating females, serious inter-current medical conditions including congestive heart failure, cardiac arrhythmias, or symptomatic coronary artery diseases are ineligible.
  2. No prior treatment allowed. No prior thoracic radiation.

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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): NCT00230451

United States, Michigan
University of Michigan Cancer Center
Ann Arbor, Michigan, United States, 48197
Sponsors and Collaborators
University of Michigan Cancer Center
Principal Investigator: Susan Urba, M.D. University of Michigan Cancer Center

Responsible Party: Susan G. Urba, M.D., University of Michigan Identifier: NCT00230451     History of Changes
Other Study ID Numbers: UMCC 9740
First Posted: September 30, 2005    Key Record Dates
Last Update Posted: January 15, 2010
Last Verified: January 2010

Additional relevant MeSH terms:
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs