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 gastroesophageal junction. In the brief phase I portion of this trial, we will determine whether 2 drugs (docetaxel/oxaliplatin) or 3 drugs (docetaxel/oxaliplatin/capecitabine) can be used concurrently with radiation therapy. If the 3-drug regimen is tolerated, the phase II portion will proceed with this regimen. If the 3-drug combination is considered too toxic, the phase II study will proceed with docetaxel/oxaliplatin in combination with radiation therapy.
Upon determination of eligibility, patients will be receive: Oxaliplatin + Docetaxel + Capecitabine + Radiation therapy If the three-drug chemotherapy regimen, with radiation therapy, is tolerable, this regimen will be taken forward into the phase II portion of the trial. If the three-drug regimen is too toxic, the phase II portion will proceed with the two-drug regimen Oxaliplatin + Docetaxel + Radiation therapy
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
59
40 mg/m2 IV over 2 hours on days 1, 8, 15, 22, and 29 in both treatment cohorts
20 mg/m2 IV over 30 minutes was administered on days 1, 8, 15, 22, and 29 in both cohorts
In Cohort 2, capecitabine was administered 1000 mg/m2 orally twice daily on days 1 to 7, 15 to 21, and 29 to 35.
In both cohorts, radiation therapy began concurrently with day 1 of chemotherapy at a dose of 1.8 Gy/d Monday through Friday to a total of 45 Gy (25 fractions).
Tower Oncology
Beverly Hills, California, United States
Integrated Community Oncology Network
Jacksonville, Florida, United States
Atlanta Cancer Care
Atlanta, Georgia, United States
Northeast Georgia Medical Center
Gainesville, Georgia, United States
Wellstar Cancer Research
Marietta, Georgia, United States
Consultants in Blood Disorders and Cancer
Louisville, Kentucky, United States
Tennessee Oncology
Nashville, Tennessee, United States
Pathologic Complete Response Rate (PCRR), the Percentage of Patients Who Have No Evidence of Cancer in Their Surgical Specimen Following Surgery
The absence of any residual tumor cells in a histologic evaluation of a tumor specimen following surgery is defined as a complete pathologic response
Time frame: 18 months
Disease-Free Survival (DFS)
Defined as the interval between the start date of treatment and the date of occurrence of progressive disease or death from any cause.
Time frame: 18 months
Overall Survival (OS)
Length of time, in months, that patients were alive from their first date of protocol treatment until death.
Time frame: 36 months
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