Paclitaxel, Carboplatin, Infusional 5-Fluorouracil, and Radiation Therapy With or Without Surgical Resection in Locally Advanced Esophageal Cancer
18 Years
N/A
Both
Esophagus Cancer
Trial Information
Paclitaxel, Carboplatin, Infusional 5-Fluorouracil, and Radiation Therapy With or Without Surgical Resection in Locally Advanced Esophageal Cancer
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, patients will be randomized to
receive one of two treatments:
- Surgical resection (Arm A)
- Paclitaxel + Carboplatin + Radiation (Arm B)
Inclusion Criteria:
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 Criteria:
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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
To compare the efficacy of full dose radiation therapy versus preoperative radiation therapy plus surgical resection, when used in combination with neo-adjuvant chemotherapy, in the treatment of localized esophageal cancer
Principal Investigator
John D. Hainsworth, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Sarah Cannon Research Institute
Authority:
United States: Food and Drug Administration
Study ID:
SCRI GI 23
NCT ID:
NCT00193141
Start Date:
October 1999
Completion Date:
July 2007
Related Keywords:
- Esophagus Cancer
- Esophageal Neoplasms
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