In cases of esophageal cancer, should surgery always be performed after successful preliminary treatment (“as a matter of principle”)—or only when it is truly still necessary (“as needed”)?

Esophageal cancer (esophageal carcinoma) is a malignant disease caused by the uncontrolled growth of cells in the esophagus. The most common symptoms include difficulty swallowing, pain when swallowing, weight loss, hoarseness, and coughing. However, most symptoms do not appear until the later stages of the disease. For non-metastatic esophageal cancer—that is, cancer that has not spread to other organs—standard treatment begins with neoadjuvant therapy, which involves chemotherapy or a combination of radiation and chemotherapy (radiochemotherapy). This is followed by surgery to remove the affected portion of the esophagus. Chemotherapy or chemoradiotherapy prior to surgery can further improve treatment outcomes by destroying microscopic, invisible tumor deposits. The surgery is therefore performed even if no tumor cells are detectable after the preoperative treatment (complete remission). This treatment strategy is referred to as “on principle” (in every case). Surgery is often associated with increased risks. In addition, removal of the esophagus is a major procedure that can be very physically and emotionally taxing for patients—with possible consequences such as difficulty swallowing, a prolonged recovery period, and limitations in daily life. A novel alternative to this is “as-needed” surgery. In this approach, patients are closely monitored after completing chemotherapy or chemoradiotherapy and undergo surgery only if tumor cells are detected again. In addition to computed tomography (CT), endoscopic ultrasound and gastroscopy are also used for this purpose.

The goal of the ESORES study is to investigate whether the “as needed” treatment strategy, following a response to chemotherapy or chemoradiotherapy, is superior to “on principle” surgery in terms of quality of life and survival rate. As part of the study, patients are randomly assigned to two groups. Group 1 is treated according to the “as needed” strategy. Ten weeks after completion of chemotherapy or chemoradiotherapy, the response to treatment is assessed using various tests. Complete surgical removal of the esophagus is performed only if cancer cells are detected again. In the event of complete remission (no detectable tumor cells), surgery is not performed, and frequent follow-up examinations are scheduled. In the event of tumor recurrence, treatment of the patients continues with surgery. Group 2 undergoes surgery as standard following pre-treatment (regardless of the response to the pre-treatment). The study is open-label, meaning that medical staff and patients know which group they have been assigned to. Treatments and follow-up examinations as part of the study will continue for up to 7 years. The primary endpoint of the study is overall survival.

Women and men aged 18 and older with non-metastatic esophageal cancer who have completed neoadjuvant chemotherapy or combined chemoradiotherapy are eligible to participate in this study.