Status:
COMPLETED
Chemotherapy With or Without Surgical Resection in Locally Advanced Esophageal Cancer
Lead Sponsor:
SCRI Development Innovations, LLC
Collaborating Sponsors:
Bristol-Myers Squibb
Conditions:
Esophagus Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
In this randomized study, we plan to address the important question of optimum local treatment for patients with localized esophageal cancer. All patients will receive our previously studied neo-adjuv...
Detailed Description
Upon determination of eligibility, all patients will receive neo-adjuvant therapy with: Paclitaxel + Carboplatin + 5-Fluorouracil + Radiation After neo-adjuvant therapy and restaging are completed, ...
Eligibility Criteria
Inclusion
- To be included in this study, you must meet the following criteria:
- Cancer of the esophagus or gastroesophageal junction confirmed by biopsy (squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma) clinical stage I, II, or III.
- Received no previous treatment for esophageal cancer.
- Measurable or evaluable disease
- Able to perform activities of daily living with minimal assistance
- Adequate bone marrow, liver and kidney function
- Be at least 3 weeks from any major surgical procedures.
- Have an indwelling central venous access catheter.
- Patients must be able to understand the nature consent of the study and give written informed consent.
Exclusion
- You cannot participate in this study if any of the following apply to you:
- Age \< 18 years
- History of a prior malignancy within the past 5 years
- History of significant heart disease
- Inoperable on the basis of co-existent medical problems
- Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.
Key Trial Info
Start Date :
October 1 1999
Trial Type :
INTERVENTIONAL
End Date :
July 1 2007
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00193141
Start Date
October 1 1999
End Date
July 1 2007
Last Update
May 3 2011
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.