JCOG1217: A phase III study for the prevention of esophageal stricture after endoscopic submucosal dissection

JRCT ID: jRCTs031180118

Registered date:13/02/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Early stage esophageal cancer after endoscopic submucosal dissection (ESD)
• Date of first enrollment: 07/10/2014
• Target sample size: 280
• Study type: Interventional

Intervention(s)

A: Local steroid (triamcinolone acetonide) injection to the ulcer immediately after ESD. Total amount of injected triamcinolone is 100 mg.
B: Oral steroid (predonisolone) administration two days after ESD. Predonisolone is administered over 8 weeks, started at 30 mg/day and tapered to 20 mg/day by 5 mg per two weeks, and then to 0 mg by 5 mg per week

Outcome(s)

• Primary Outcome: stricture-free survival
• Secondary Outcome: the number of endoscopic balloon dilation for 12 weeks after ESD, adverse events, serious adverse events, and proportion of patients with dysphagia score =< 1 at the time of 12 weeks after ESD

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 85age old
• Gender: Both

Include criteria

1) Histologically proven esophageal squamous cell carcinoma or basaloid cell carcinoma
2) Primary tumor located in the thoracic esophagus confirmed by endoscopy
3) Primary tumor located in the epithelium or lamina propria mucosa or muscularis mucosa confirmed by endoscopy
4) Neither lymph node metastases nor distant metastases in neck, chest and abdomen confirmed by computed tomography
5) Circumferential spread of the major lesion is 1/2 or more, but not entire circumference by endoscopy
6) Length of major lesion is 50 mm or less in longitudinal axis by endoscopy.
7) Circumferential spread 1/2 or less in all sub-lesions in patients with multiple lesions
8) Aged 20 to 85 years old
9) ECOG performance status of 0 to 1
10) No prior radiotherapy to the neck, chest wall, lung, or mediastinum
11) No prior surgery for esophagus or mediastinum
12) No prior treatment for esophageal cancer except for the following:
(i)Major lesion located within 20 mm from past EMR/ESD scar.
(ii) Inability to pass a standard endoscope with a diameter of 9.6-10.4 mm through the stricture site due to past EMR/ESD scar.13) Dysphagia score of 0 14) Adequate organ functions
(i) White blood cell count >=2000/mm3 and <=12 000/mm3.
(ii) Hemoglobin >=8.0 g/dl.
(iii) Platelet >=100 000/mm3.
(iv) Total bilirubin <=2.0 mg/dl.
(v) Aspartate aminotransferase <=150 IU/l.
(vi) Alanine aminotransferase <=150 IU/l.
(vii) Creatinine <=2.0 mg/dl.
(viii) HbA1c < 7.0%.
15) Written informed consent

Exclude criteria

1) Synchronous or metachronous (within 1 years) malignancies
2) Active infection requiring systemic therapy
3) Body temperature >=38 degrees Celsius
4) Pregnancy, possible pregnancy, within 28 days after delivery or breastfeeding
5) Severe psychiatric disease
6) Patients requiring systemic steroid medication
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, proton pump inhibitor, and trimethoprim-sulfamethoxazole.
18) Glucose-6-phosphate dehydrogenase deficiency

Related Information

• Primary Sponsor: ONO Hiroyuki
• Source(s) of Monetary Support: National Cancer Center Japan
• Secondary ID(s): UMIN000015064