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Pre-operative Chemotherapy and Radiation Therapy for Esophageal Carcinoma

Primary Purpose

Esophageal Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Radiation
Paclitaxel
Cisplatin
5-Fluorouracil
Sponsored by
University of Michigan Rogel Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Patient Eligibility: Histologically confirmed squamous cell carcinoma, adenocarcinoma, or mixed adeno/squamous of the the esophagus or gastroesophageal junction. 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. Disease must be able to be encompassed in a single radiation field. No medical contraindication to surgery. All treatment is to be administered at the University of Michigan Medical Center Karnofsky Performance Status > 60% Ages 18-75 Adequate renal function (BUN <1.5 x N; creatinine <1,5 mg/dl, or measured creatinine clearance>60 ml/min.). Adequate bone marrow reserve (WBC>3500/ul; Platelets>100,000/ul.). Adequate hepatic function (Bilirubin<1.5x N; AST <2 x upper limit of normal). Prior malignancy is acceptable if the patient is considered to be cured. In most cases this will mean a 5 year disease-free period. Ability to give informed consent. Exclusion Criteria: 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. No prior treatment allowed. No prior thoracic radiation.

Sites / Locations

  • University of Michigan Cancer Center

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

First Posted
September 28, 2005
Last Updated
January 14, 2010
Sponsor
University of Michigan Rogel Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT00230451
Brief Title
Pre-operative Chemotherapy and Radiation Therapy for Esophageal Carcinoma
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 Type
Interventional

2. Study Status

Record Verification Date
January 2010
Overall Recruitment Status
Completed
Study Start Date
November 1997 (undefined)
Primary Completion Date
December 1999 (Actual)
Study Completion Date
July 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Michigan Rogel Cancer Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Radiation
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Type
Drug
Intervention Name(s)
5-Fluorouracil
Primary Outcome Measure Information:
Title
To determine the rate of complete histologic response induced by this neoadjuvant chemotherapy and radiation therapy regimen.
Secondary Outcome Measure Information:
Title
To determine the overall survival and time to relapse in patients treated with preoperative chemotherapy and radiation therapy followed by adjuvant combination chemotherapy.
Title
To assess the qualitative and quantitative toxicities of this regimen.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Patient Eligibility: Histologically confirmed squamous cell carcinoma, adenocarcinoma, or mixed adeno/squamous of the the esophagus or gastroesophageal junction. 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. Disease must be able to be encompassed in a single radiation field. No medical contraindication to surgery. All treatment is to be administered at the University of Michigan Medical Center Karnofsky Performance Status > 60% Ages 18-75 Adequate renal function (BUN <1.5 x N; creatinine <1,5 mg/dl, or measured creatinine clearance>60 ml/min.). Adequate bone marrow reserve (WBC>3500/ul; Platelets>100,000/ul.). Adequate hepatic function (Bilirubin<1.5x N; AST <2 x upper limit of normal). Prior malignancy is acceptable if the patient is considered to be cured. In most cases this will mean a 5 year disease-free period. Ability to give informed consent. Exclusion Criteria: 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. No prior treatment allowed. No prior thoracic radiation.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan Urba, M.D.
Organizational Affiliation
University of Michigan Rogel Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan Cancer Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48197
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Pre-operative Chemotherapy and Radiation Therapy for Esophageal Carcinoma

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