Pre-operative Chemotherapy and Radiation Therapy for Esophageal Carcinoma

Esophageal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00230451
• Other study ID #: UMCC 9740
• Status: Completed
• Phase: Phase 2
• First received: September 28, 2005
• Last updated: January 14, 2010
• Start date: November 1997
• Est. completion date: July 2008

Study information

• Verified date: January 2010
• Source: University of Michigan Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: July 2008
• Est. primary completion date: December 1999
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms

Intervention

Procedure:
• Radiation

Drug:
• Paclitaxel

• Cisplatin

• 5-Fluorouracil

Locations

Country	Name	City	State
United States	University of Michigan Cancer Center	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the rate of complete histologic response induced by this neoadjuvant chemotherapy and radiation therapy regimen.
Secondary	To determine the overall survival and time to relapse in patients treated with preoperative chemotherapy and radiation therapy followed by adjuvant combination chemotherapy.
Secondary	To assess the qualitative and quantitative toxicities of this regimen.