Pre-operative Chemotherapy and Radiation Therapy for Esophageal Carcinoma

A Phase II Trial of Preoperative Chemotherapy and Radiation Therapy Followed by Adjuvant Combination Chemotherapy for Patients With Loco-Regional Esophageal Carcinoma

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.

Study Overview

• Status: Completed
• Conditions: Esophageal Cancer
• Intervention / Treatment: Drug: Cisplatin; Drug: 5-Fluorouracil; Drug: Paclitaxel; Procedure: Radiation

• Study Type: Interventional
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48197
      • University of Michigan Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
To determine the rate of complete histologic response induced by this neoadjuvant chemotherapy and radiation therapy regimen.

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Michigan Rogel Cancer Center
• Investigators: Principal Investigator: Susan Urba, M.D., University of Michigan Rogel Cancer Center

Study record dates

Study Major Dates

• Study Start: November 1, 1997
• Primary Completion (Actual): December 1, 1999
• Study Completion (Actual): July 1, 2008

Study Registration Dates

• First Submitted: September 28, 2005
• First Submitted That Met QC Criteria: September 28, 2005
• First Posted (Estimate): September 30, 2005

Study Record Updates

• Last Update Posted (Estimate): January 15, 2010
• Last Update Submitted That Met QC Criteria: January 14, 2010
• Last Verified: January 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Esophageal Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Paclitaxel; Fluorouracil
• Other Study ID Numbers: UMCC 9740