superficial esophageal cancer
Conditions
Interventions
None listed
Sponsors
Osaka International Cancer institute
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Histologically confirmed squamous cell carcinoma or basaloid squamous cell carcinoma after endoscopic resection (ER) for esophageal cancer. After ER for esophageal cancer, the primary lesion is pathologically diagnosed as pVM0 and either pMM with lymphovascular invasion or pSM. In patients with multiple lesions, the lesion with the deepest invasion is defined as the primary lesion. En bloc resection has been achieved. Within 60 days after ER of the primary lesion. No additional treatment is planned after ER. No evidence of lymph node metastasis or distant metastasis on cervical, thoracic, and abdominal CT performed within 90 days before ER or after ER for esophageal cancer. No prior history of radiotherapy to the cervical region, thorax, lung fields, or mediastinum before the target ER, including radiotherapy for other malignancies. No prior treatment history for esophageal cancer before the target ER. However, prior ER for esophageal cancer is permitted if the pathological findings were pT1a-EP/LPM with negative lymphovascular invasion and negative vertical margin. Age >= 20 years at registration. Patients must agree to undergo either of the following surveillance strategies: a. Recommended surveillance 0-3 years after ER: contrast-enhanced CT of the neck, chest, and abdomen every 4 (3-5) months, and EGD (+EUS) at least once yearly 3-5 years after ER: contrast-enhanced CT of the neck, chest, and abdomen every 6 (4-8) months, and EGD (+EUS) at least once yearly Non-contrast CT is permitted in patients unable to receive contrast agents because of renal dysfunction, contrast allergy, or other reasons. b. Outpatient follow-up at least once yearly with CT examinations as clinically indicated. Written informed consent for study participation has been obtained from the patient.
Exclusion criteria
Exclusion criteria: Presence of a prior or synchronous double cancer within the past 3 years; however, this does not include cancers with an estimated 5-year relative survival rate of >=95%. Presence of psychiatric disorders or psychiatric symptoms that significantly interfere with activities of daily living and are judged to make study participation difficult. Judged by the principal investigator or sub-investigator to be inappropriate for inclusion in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 3-year overall survival in the primary analysis population | — |
Secondary
| Measure | Time frame |
|---|---|
| 5-year overall survival in the primary analysis population Distant recurrence-free survival and esophagus-preservation survival at 3 and 5 years in the primary analysis population Treatment for recurrent lesions and recurrence-free survival after recurrence treatment in patients with recurrence in the primary analysis population Patterns of metastatic recurrence in the recommended surveillance cohort Metastatic recurrence rates at 3 and 5 years in the overall study population | — |
Countries
Japan
Contacts
Public ContactShunsuke Yoshii
Osaka International Cancer Institute Department of Gastrointestinal Oncology
Outcome results
None listed