Esophageal cancer
Conditions
Interventions
None listed
Sponsors
National Cancer Center Hospital East
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) The esophageal primary lesion has been diagnosed histologically as either adenocarcinoma, squamous cell carcinoma, adenosquamous carcinoma, or basaloid carcinoma based on endoscopic biopsy. 2) The primary esophageal lesion must be located within the thoracic esophagus, as defined by the UICC TNM-8th edition. However, cases in which the tumor center is located distal to a line 1 cm oral to the esophagogastric junction-identified endoscopically as either the lower edge of the palisade vessels or the upper margin of the gastric-folds are excluded, as these correspond to Siewert type II/III tumors. 3) The esophageal lesions may be single or multiple. Secondary lesions in the cervical esophagus are eligible if endoscopic treatment (EMR/ESD) is applicable, even if present. 4) The clinical stage is II (T3N0M0), III, or IVA, or IVB with M1a (supraclavicular lymph node metastasis) according to the JES classification, based on UICC TNM 8th edition. However, if preoperative therapy is performed, the following conditions must be met: The clinical stage before treatment is II (T3N0M0), III, or IVA, or IVB with M1a (supraclavicular lymph node metastasis) according to the JES classification. The regimen is not limited. No distant metastasis is observed after preoperative treatment. 5) The patient's age at the time of surgery is between 20 and 80 years. 6) The Performance Status (PS) is 0 or 1 according to the ECOG criteria. 7) No prior treatment for esophageal cancer. However, the following treatment history is acceptable: Endoscopic treatment (EMR/ESD) for the primary lesion was performed but did not result in curative resection (pT1a LPM or superficial with negative resection margins). The patient has undergone preoperative chemotherapy.
Exclusion criteria
Exclusion criteria: The patient has active multiple cancers (synchronous or metachronous multiple cancers, with a disease-free interval of less than 5 years). However, carcinoma in situ or lesions equivalent to mucosal carcinoma, which are considered cured by local treatment, are not included as active multiple cancers. The patient is undergoing continuous systemic administration of steroids or other immunosuppressive agents. The patient has uncontrolled diabetes despite continuous use of insulin. The patient has severe emphysema or pulmonary fibrosis as detected by pulmonary function tests or CT scans. The patient has unstable angina (angina that has occurred or worsened within the past 3 weeks) or has a history of myocardial infarction within the past 6 months. The patient has renal dysfunction (dialysis, creatinine 1.5), or severe liver dysfunction (total bilirubin >1.5, AST >100, ALT >100). The patient who underwent salvage surgery after definitive chemoradiotherapy will be excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Superiority of the 3-year recurrence-free survival rate | — |
Secondary
| Measure | Time frame |
|---|---|
| 3-year overall survival rate, rate of curative resection, rate of reoperation, conversion rate, complication rate, recurrent laryngeal nerve palsy rate, respiratory complication rate, postoperative surgical invasiveness (postoperative CRP), number of upper mediastinal lymph node dissections, local control rate (presence or absence of local recurrence), 3-year recurrence-free survival rate by TNM stage | — |
Countries
Japan
Contacts
Public ContactTakeo Fujita
National Cancer Center Hospital East Department of Esophageal Surgery
Outcome results
None listed