The goal of this trial is to learn if adding consolidative chemotherapy to routine chemoradiation can better control both local recurrence and metastasis and reduce the need for surgical intervention.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Modified-FOLFOX-6 or FLOT (Fluorouracil, Leucovorin, Oxaliplatin, Docetaxel)
Duke University Medical Center
Durham, North Carolina, United States
Number of participants with Clinical complete response (cCR)
cCR defined as absence of malignancy on endoscopic biopsies obtained at the time of reassessment following neoadjuvant therapy
Time frame: approximately 36 weeks
Number of participants with pathologic complete response (pCR)
Pathologic complete response (pCR) is defined as absence of detectable tumor of esophagectomy tissues.
Time frame: approximately 36 weeks
Number of participants who complete both chemoradiation and chemotherapy
Time frame: approximately 36 weeks
Number of participants with local control
Local control in participants achieving clinical complete remission (cCR) estimated using the Kaplan-Meier method. cCR is defined as the disappearance of all detectable signs and symptoms of a disease, such as cancer, have completely disappeared.
Time frame: up to 5 years
Number of participants with Disease free survival
Disease free survival in participants achieving cCR estimated using the Kaplan-Meier method. cCR is defined as the disappearance of all detectable signs and symptoms of a disease, such as cancer, have completely disappeared.
Time frame: up to 5 years
Time to distant metastasis
Time to distant metastasis in participants achieving cCR estimated using the Kaplan-Meier method. cCR is defined as the disappearance of all detectable signs and symptoms of a disease, such as cancer, have completely disappeared.
Time frame: up to 5 years
Overall survival
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Measured in participants achieving cCR and estimated using the Kaplan-Meier method. cCR is defined as the disappearance of all detectable signs and symptoms of a disease, such as cancer, have completely disappeared.
Time frame: up to 5 years
Number of participants with Local control
Measured in participants achieving pCR and estimated using the Kaplan-Meier method. pCR is defined as absence of detectable tumor of esophagectomy tissues.
Time frame: up to 5 years
Disease free survival
Disease free survival in participants achieving pCR. pCR is defined as absence of detectable tumor of esophagectomy tissues.
Time frame: up to 5 years
Time to distant metastasis
Time to distant metastasis in participants achieving pCR estimated using the Kaplan-Meier method. pCR is defined as absence of detectable tumor of esophagectomy tissues.
Time frame: up to 5 years
Overall survival
Measured in participants achieving pCR and estimated using the Kaplan-Meier method. pCR is defined as absence of detectable tumor of esophagectomy tissues.
Time frame: up to 5 years