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.
Subject must be able to provide study specific informed consent prior to study entry
Must be newly diagnosed, histologically proven diagnosis of adenocarcinoma of the thoracic esophagus or gastroesophageal junction (Siewert I-II);
Stage II-IVA, excluding T4b, according to the American Joint Committee on Cancer (AJCC) 8th edition;
Complete history and physical examination within 21 days of signing consent;
Cervical esophageal cancers arising 15-18 cm from the incisors.
Esophageal squamous cell carcinoma.
Patients with T4b disease according to the AJCC 8th Edition.
Definitive clinical or radiologic evidence of metastatic disease.
Single group
FOLFOX (5-fluorouracil, Leucovorin, Oxaliplatin)
DrugModified-FOLFOX-6 or FLOT (Fluorouracil, Leucovorin, Oxaliplatin, Docetaxel)
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
Number of participants with pathologic complete response (pCR)
Pathologic complete response (pCR) is defined as absence of detectable tumor of esophagectomy tissues.
Number of participants who complete both chemoradiation and chemotherapy
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.
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.
Click on the lead sponsor to view all of their trials.
