Participants in this study will have esophageal cancer that has spread (metastasized) to other parts of the body either at initial diagnosis (synchronous) or after the cancer returned following treatment (recurrent). In Alberta, the current standard approach for treating esophageal cancer that has metastasized is to first give patients radiation to the main tumor in the esophagus to relieve symptoms. After that, they receive a combination of chemotherapy drugs (either CAPOX or FOLFOX) chosen by their doctor, along with immunotherapy drugs like Pembrolizumab or Nivolumab to fight the cancer. The study intends to add a treatment called stereotactic body radiation treatment (SBRT), which uses very high doses of radiation in a few sessions, to target small tumors which remain after the standard treatment. The goal of this study is to see if adding SBRT to chemotherapy and immunotherapy helps patients with newly diagnosed or recurrent esophageal cancer that has metastasized to a few other places. The study aims to improve survival and control the disease better.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
22
Standard of care 6-9 cycles of chemotherapy and immunotherapy, which will then be followed by stereotactic body radiation treatment to the residual oligometastatic lesion/s.
Progression free survival
Defined as time from enrollment into study to disease progression at any site or death.
Time frame: From the date of enrollment in the study for up to approximately 2 years and 7 months or death.
Local recurrence free survival
Defined as time from enrollment into study to disease progression at site of SBRT treatment or death.
Time frame: From the date of enrollment in the study for up to approximately 2 years and 7 months or death.
Overall Survival (OS)
Defined as the time from enrollment into study to death due to any cause.
Time frame: From the date of enrollment until the time of death due to any cause, assessed up to approximately 2 years and 7 months
Quality of Life (QOL)
To study the Quality of Life as measured by European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) (v3)
Time frame: Screening, 1 - 5 days before the start of each chemotherapy cycle (each cycle is 21 days), 14 - 28 days after completion of chemotherapy (chemotherapy is completed in about 4 months), and 3 monthly after SBRT until 2 years post SBRT
Cancer Specific Survival (CSS)
Defined as the time from time of enrollment into study to death due to the esophageal cancer.
Time frame: From enrollment until the time of death due to esophageal cancer, assessed up to about 2 years and 7 months.
Toxicity Assessment
Treatment related toxicity will be assessed using the Common Terminology Criteria for Adverse Events (CTCAE) Version 5
Time frame: 10 - 20 days after screening (if given), 1 - 5 days prior each cycle of chemotherapy (each cycle is 21 days), 14 - 28 days after end of chemotherapy which is about 4 months, 14-28 days after chemotherapy and 3 monthly after SBRT until 2 years post SBRT.
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