Metastatic esophageal carcinoma Metastatic esophageal cancer
Conditions
Interventions
Not applicable: This is an explorative prospective observational cohort study.
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Histologically proven carcinoma of the esophagusPatients with metastatic disease (M1), or patients that decline curative treatmentFit for palliative radiotherapyAge of 18 years and olderWritten informed consent according to local guidelines.
Exclusion criteria
Exclusion criteria: Sarcoma, melanoma, neuro-endocrine or small cell esophageal cancer.Patients with previous thoracic radiotherapy.Chemotherapy treatment in the last year.Patients with previous or current hematologic tumors.History of an autoimmune disease or other systemic intercurrent disease that might affect the immunocompetence of the patient, or current or prior use (6 months before start of the trial) of high dose immunosuppressive therapy. Active infection requiring systemic therapy. Current pregnancy.History or current evidence of any condition, therapy or laboratory abnormality that might confound the results of this trial, interfere with the subject’s participation for the full duration of this trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in absolute lymphocyte count (ALC), at the end of Radiotherapy, compared to baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| Lymphocyte nadirLymphopenia grade III according to the CTCAE v5.0 (<0.5 × 10^9/L)Lymphopenia grade IV according to the CTCAE v5.0 (<0.2 × 10^9/L)T-cells including CD4+ and CD8+ fractions and ratio, other T-cell subtypes like Treg, ga/d T-cell, their differentiation status (naïve, EM, exhausted), B-cells, NK cells, and myeloid suppressor cellsTumor-infiltrating lymphocytes (TILs), assessed using flow cytometry and immunohistochemistry (if applicable) tumor response at the first restaging scan (12 weeks post-treatment), using (i)RECIST criteria | — |
Countries
Netherlands
Contacts
Public ContactC.T. Muijs
Universitair Medisch Centrum Groningen
Outcome results
None listed