Status:
COMPLETED
Preoperative Therapy With Oxaliplatin/Docetaxel/Capecitabine and Radiation in Resectable Esophagus Cancer
Lead Sponsor:
SCRI Development Innovations, LLC
Collaborating Sponsors:
Sanofi-Synthelabo
Aventis Pharmaceuticals
Conditions:
Esophagus Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
In this phase I/II trial, we will evaluate a novel combination of chemotherapy, used concurrently with radiation therapy, in the preoperative therapy of locoregional carcinoma of the esophagus and gas...
Detailed Description
Upon determination of eligibility, patients will be receive: Oxaliplatin + Docetaxel + Capecitabine + Radiation therapy If the three-drug chemotherapy regimen, with radiation therapy, is tolerable, ...
Eligibility Criteria
Inclusion
- To be included in this study, you must meet the following criteria:
- Adenocarcinoma or squamous cell carcinoma of the esophagus or G/E junction.
- Must be surgical candidates
- No previous treatment for esophageal cancer
- Must have measurable or evaluable disease
- Able to perform activities of daily living with minimal to no assistance
- Adequate bone marrow, liver and kidney function
- Provide written informed consent
Exclusion
- You cannot participate in this study if any of the following apply to you:
- Tumor location in the proximal esophagus
- Metastatic disease or locally advanced cancer
- Moderate to severe peripheral neuropathy
- Serious pre-existing medical illnesses
- Significant heart disease
- Treated for an invasive cancer within the previous 5 years
- Women who are pregnant or breast-feeding
- Age \< 18 years
- 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 :
April 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2009
Estimated Enrollment :
59 Patients enrolled
Trial Details
Trial ID
NCT00193128
Start Date
April 1 2004
End Date
January 1 2009
Last Update
November 24 2021
Active Locations (7)
Enter a location and click search to find clinical trials sorted by distance.
1
Tower Oncology
Beverly Hills, California, United States, 90211
2
Integrated Community Oncology Network
Jacksonville, Florida, United States, 32256
3
Atlanta Cancer Care
Atlanta, Georgia, United States, 30342
4
Northeast Georgia Medical Center
Gainesville, Georgia, United States, 30501