JPRN-jRCTs051200048
Recruiting
Phase 2
Phase II study of adjuvant chemotherapy with S-1 for cStage II and III thoracic esophageal cancer following neoadjuvant chemotherapy and curative esophagectomy - SUNSHINE Trial
Kitadani Junya0 sites27 target enrollmentAugust 26, 2020
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Kitadani Junya
- Enrollment
- 27
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •(1\) Histologic confirmation of squamous cell carcinoma or adenocarcinoma
- •orbasaloid carcinoma by endoscopic biopsy
- •(2\) Carcinoma are all localized in the thoracic esophagus
- •(3\) TMN clinical stage II, III
- •(4\) 20 years and older, under 80 years old
- •(5\) ECOG performance status 0\-1
- •(6\) Patients who received more than 2 courses of docetaxel \+ cisplatin \+
- •S\-1 (DCS therapy) as preoperative adjuvant chemotherapy
- •(7\) Patients who underwent curative esophagectomy (R0\) with any surgical approach
- •(8\) Patients who can start adjuvant chemotherapy
Exclusion Criteria
- •1\)Patients with concurrent other primary cancer requiring treatment
- •2\)Patients whose recurrence has already been confirmed at the time of registration
- •3\)Pregnancy, possibly pregnant, or breast feeding
- •4\)Patients with psychosis or psychiatric symptoms
- •5\)Patients requiring systemic administration of steroids
- •6\)Positive HBs antigen
- •7\)Severe hypersensitivity to S\-1
- •8\)Under treatment with flucytosine, phenytoin or warfarin
- •9\)Complication with interstitial pneumonia, pulmonary fibrosis, or severe emphysema
- •10\)Dementia
Outcomes
Primary Outcomes
Not specified
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