clinical stage IA esphageal cancer
Conditions
Interventions
Conventional and magnifying endoscopy, Endoscopic ultrasonography (EUS)
Sponsors
Japan Clinical Oncology Group (JCOG)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1st registration 1. Histologically proven squamous cell carcinoma or diagnosed as esophageal cancer (EC) by endoscopy according to Japanese Classification of Esophageal Cancer, 11th Edition. Also eligible in histologically proven high grade intraepithelial neoplasia according to 10th Edition 2. cN0M0 if CT examination is performed. Also eligible without imaging examination 3. Primary tumor is located in the thoracic esophagus 4. Depth of invasion of the deepest tumor is diagnosed as cT1 EC by conventional endoscopy. But ineligible when evidently diagnosed as cEP or cLPM 5. Length of the lesion is estimated <= 5 cm in longitudinal axis 6. Aged 20 to 85 years old 7. ECOG PS of 0-2 8. No evident entire circumferential lesion for patients with PS 2 and/or aged >= 81 years old 9. Magnifying endoscopy or EUS is judged to pass through by the endoscopic examination before 1st registration. Endoscopic dilation is allowed to pass through the magnifying endoscopy or EUS 10. No prior history of thoracic radiotherapy for any cancers 11. No prior history of esophagectomy for EC 12. Prior history of ER for EC is allowed. Ineligible if the scar after ER is located within <= 10 mm from the lesion 13. No preference of chemoradiotherapy or radiotherapy for primary treatment 14. Written informed consent 2nd registration 1. cN0M0 if examination is performed by CT before 2nd registration. Also eligible without imaging examination at 2nd registration 2. Depth of invasion is diagnosed as cMM or cSM by conventional and magnifying endoscopy 3. The upper end of the tumor is located at >= 2 cm from esophageal orifice, and the lower end of the tumor is located at >= 1 cm from esophagogastric junction 4. Length of the lesion is <= 5 cm in longitudinal axis 5. No entire circumferential lesion for patients with PS 2 and/or aged >= 81 years old 6. The scar after ER is located >= 10 mm from the lesion if the patient has prior history of ER
Exclusion criteria
Exclusion criteria: 1. Active infection requiring systemic therapy 2. Body temperature >= 38 degrees Celsius 3. Pregnancy, possible pregnancy within 28 days after delivery or breastfeeding 4. Severe psychiatric disease 5. Poorly controlled hypertension 6. Unstable angina within 3 weeks, or with a history of myocardial infarction within 6 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of pathological SM1 or shallower lesions in those with a diagnosis of clinical SM2 or deeper. | — |
Secondary
| Measure | Time frame |
|---|---|
| The proportion of pathological SM2 or deeper lesions in those with a diagnosis of clinical SM1 or shallower, sensitivity, specificity, positive predictive value, negative predictive value, adverse events | — |
Countries
Japan
Contacts
Public ContactRyu Ishihara
JCOG1604 Coordinating Office Gastrointestinal Oncology Division, Osaka International Cancer Institute
Outcome results
None listed