Esophageal cancer
Conditions
Interventions
None listed
Sponsors
OKI Eiji
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. The subject is 20 years of age or older at the time of obtaining informed consent. 2. Written informed consent to participate as a study subject for the examinations specified in this protocol has been obtained directly from the subject. 3. The subject has been judged by the site principal investigator to be eligible for treatment under this protocol (appropriate for enrollment). 4. Esophageal cancer has been histologically confirmed as squamous cell carcinoma, adenosquamous carcinoma, or basaloid carcinoma. 5. The clinical stage is Stage I to IV according to the TNM classification (UICC-TNM, 8th edition), with the following conditions: For cStage I, the subject must be cN1. For cStage IVA (T4a, T4b), the subject must be diagnosed as resectable with R0 resection following preoperative treatment. For cStage IVB, M1 limited to supraclavicular lymph node (station 104) metastasis is eligible if lymph node dissection is performed and no macroscopic residual disease remains. 6. The subject is scheduled to undergo curative resection (R0) by McKeown or Ivor-Lewis esophagectomy. Surgical approaches such as robot-assisted surgery, thoracoscopic surgery, or mediastinoscopic surgery are permitted. 7. One-stage esophagectomy and reconstruction is planned or has been performed. 8. The subject has no prior history of any surgical treatment for esophageal cancer. 9. The regimen of preoperative chemotherapy or chemotherapy as part of chemoradiotherapy is not restricted. 10. ECOG Performance Status is 2 or less. 11. The subject has no severe impairment of major organ function and is considered capable of undergoing surgery and postoperative follow-up. If multiple test results are available within the specified period, the results obtained closest to the time of enrollment shall be used.
Exclusion criteria
Exclusion criteria: 1.Endoscopic treatment as prior therapy is excluded, except in cases where an advanced cancer is present as the primary lesion. 2.Transabdominal resection and reconstruction are excluded. 3.Subjects with a history of, or comorbid, clinically significant psychiatric disorders or central nervous system disorders that make regular hospital visits difficult (including conditions judged to make regular examinations such as blood tests difficult) are excluded. 4.Subjects with active double cancers are excluded, except for those with completely resected basal cell carcinoma, Stage I squamous cell carcinoma, carcinoma in situ, intramucosal carcinoma, superficial bladder cancer, or a history of other cancers with no recurrence for at least 5 years. 5.Any other subjects deemed inappropriate for participation in this study by the site principal investigator or treating physician are excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Predictive accuracy for recurrence-free status in the postoperative day 28 ctDNA-negative group | — |
Secondary
| Measure | Time frame |
|---|---|
| Recurrence-free predictive accuracy in ctDNA-negative patients at postoperative day 28 who did not receive adjuvant therapy Two-year recurrence-free survival rate in the ctDNA-positive group at postoperative day 28 Overall survival rate in the ctDNA-positive group at postoperative day 28 | — |
Contacts
Public ContactYasue KIMURA
NHO Kyushu Cancer Center
Outcome results
None listed