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.
Age ≥ 18
Eastern Cooperative Oncology Group performance status ≤ 2.
Histologically confirmed adenocarcinoma or squamous cell carcinoma of the esophagus.
Diagnosed with stage IVB disease (according to UICC TNM version 8) with up to five metastatic lesions in up to three organs.
Progression was confirmed after completion of 4 to 6 cycles of standard chemotherapy and anti-PD1 treatment and not amenable to SBRT.
Known or suspected allergy or hypersensitivity to monoclonal antibodies and the chemotherapeutic drugs: Capecitabine, paclitaxel, or platinum.
Patients have spinal bone metastases combined with spinal cord compression.
A history of malignancies other than esophageal cancer before enrollment, excluding non-melanoma skin cancer, in situ cervical cancer, or cured early prostate cancer.
Single group
Stereotactic body radiation treatment (SBRT)
RadiationStandard 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.
Local recurrence free survival
Defined as time from enrollment into study to disease progression at site of SBRT treatment or death.
Overall Survival (OS)
Defined as the time from enrollment into study to death due to any cause.
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)
Cancer Specific Survival (CSS)
Defined as the time from time of enrollment into study to death due to the esophageal cancer.
To identify blood biomarkers that can correlate with disease events
Blood samples will be compared between the baseline and subsequent samples for changes in the expression levels of specific markers that may be associated with metastases and treatment response. These include circulating cell free DNA and exosomes.
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This trial is not recruiting at the moment. You can still explore other options:
