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


Phase 2
18 Years
75 Years
Not Enrolling
Both
Esophageal Cancer

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Trial Information

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

Inclusion Criteria


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Principal Investigator

Susan Urba, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Michigan Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

UMCC 9740

NCT ID:

NCT00230451

Start Date:

November 1997

Completion Date:

July 2008

Related Keywords:

  • Esophageal Cancer
  • Carcinoma
  • Esophageal Diseases
  • Esophageal Neoplasms

Name

Location

University of Michigan Cancer CenterAnn Arbor, Michigan  48109