JCOG2315: A randomized controlled phase III study comparing local steroid injection alone versus combination therapy of local steroid injection and oral steroid administration for the prevention of esophageal stricture after wide-spreading endoscopic submucosal dissection (E-COMBI)
- Conditions
- Widespread superficial esophageal cancer
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 420
1st inclusion criteria (1) Meet either of the following. (a) Histologically proven squamous cell carcinoma, basaloid carcinoma, adenosquamous carcinoma, or adenocarcinoma. (b) Histologically proven squamous intraepithelial neoplasia and endoscopically diagnosed as esophageal cancer. (c) No histologically proven esophageal cancer, but endoscopically diagnosed as esophageal cancer. (2) Major lesion and adjacent sub-lesions located in the cervical esophagus to the esophagogastric junction diagnosed by endoscopy. (3) The depth of invasion of the major lesion and sub-lesions is diagnosed as cT1a by endoscopy. (4) Neither lymph node metastases nor distant metastases in neck, chest and abdomen confirmed by contrast-enhanced CT. (5) Circumferential spread of the major lesion is 3/4 or more, but not entire circumference diagnosed by endoscopy (6) Length of major lesion is 80 mm or less in longitudinal axis diagnosed by endoscopy. (7) Circumferential spread is 1/2 or less in all sub-lesions in patients with multiple lesions (8) Aged 18 to 85 years old (9) Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. (10) No prior radiotherapy to the neck, chest wall, lung, or mediastinum (11) No prior surgery for esophagus or mediastinum. (12) No plan of treatment other than protocol treatment for pharyngolarynx and esophagus within 13 weeks after first registration. (13) No prior treatment for esophageal cancer unless all of the following are met. (a) Curative resection (pT1a,Ly0,V0,pVM0) was performed by EMR/ESD. (b) No stricture after EMR/ESD. (c) No past EMR/ESD scar contact with major lesion and adjacent sub-lesions. (14) Dysphagia score >=1. (15) Sufficient organ function (a) White blood cell count >=2,000/mm3 and <=12,000/mm3. (b) Hemoglobin >=8.0 g/dL. (c) Platelet >=100,000/mm3. (d) Total bilirubin <=2.0 mg/dL. (e) Aspartate aminotransferase <=150 U/L. (f) Alanine aminotransferase <=150 U/L. (g) Creatinine <=2.0 mg/dL. (h) HbA1c <7.0% (16) Written informed consent
2nd inclusion criteria (1) After first registration in this study. (2) ESD and local steroid injection have been performed for esophageal cancer and within 6 days from the date of ESD. (3) En bloc endoscopic resection with no endoscopically evident residual tumor. (4) Circumferential spread of the post-ESD mucosal defect is more than 7/8 but not entire circumference, and the longitudinal diameter of the post-ESD mucosal defect is 100 mm or less. (5) Oral steroid administration is possible. (6) Meet all the following within 1 day. (a) Body temperature <38.0 degrees Celsius (b) Infection <=Grade 0
(1) Synchronous or metachronous (within 1 year) malignancies. (2) Active infection requiring systemic therapy. (3) Body temperature >=38.0 degrees Celsius. (4) Pregnancy, possible pregnancy, within 28 days after delivery or breastfeeding. (5) Severe psychiatric disease. (6) Receiving continuous systemic steroid or immunosuppressant treatment. (7) Uncontrollable diabetes mellitus. (8) Patients requiring continuous anticoagulant or antiplatelet drug. (9) Poorly controlled hypertension. (10) History of unstable angina within 3 weeks or myocardial infarction within 6 months. (11) Patients with respiratory disease requiring continuous supplemental oxygen. (12) Active gastroduodenal ulcer. (13) Glaucoma, posterior capsule opacification or herpetic keratitis, examination by ophthalmologist is not necessarily required. (14) History of any surgery within 3 months. (15) Positive HBs antigen. (16) Allergy to Iodine. (17) Hypersensitivity for triamcinolone acetonide, prednisolone, trimethoprim-sulfamethoxazole, proton pump inhibitor, and potassium competitive acid blocker. (18) Glucose-6-phosphate dehydrogenase deficiency.
Study & Design
- Study Type
- Interventional
- Study Design
- parallel assignment
- Primary Outcome Measures
Name Time Method - Stricture-free survival
- Secondary Outcome Measures
Name Time Method The number of endoscopic balloon dilation 12 weeks after ESD The number of endoscopic balloon dilation for 12 weeks after ESD
Proportion of patients with dysphagia score =<1 12 weeks after ESD Proportion of patients with dysphagia score =<1 at the time of 12 weeks after ESD