Phase II study of perioperative chemotherapy for cStage II and III thoracic esophageal cancer

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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs051200048

Enrollment

Registered

2020-08-26

Start date

2020-12-08

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

esophageal cancer

Interventions

Adjuvant S-1 chemotherapy (50-120 mg/body/day, PO, day 1-28, every 42 days) is planned for 8 courses after surgery for patients with cStage II and III esophageal cancer who received two or more cour

Eligibility

Sex/Gender

All

Inclusion 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 (9) Patients with normal oral intake (10) Laboratory values as follows 1. Neutrophil count>=1,200/mm3 2. Hemoglobin>=8.0 g/dL 3. Platelet count>=75000/mm3 4. Total bilirubin =40 mL/min (11) Informed consent has been obtained

Exclusion criteria

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 11)Active infection 12)History of myocardial infarction or unstable angina within 6 months before the date of registration 13)Uncontrolled hypertension 14)Uncontrolled diabetes mellitus 15)Not recovering from postoperative complications by the time of registration 16)Patients who are considered ineligible to enroll

Design outcomes

Primary

Measure	Time frame
Recurrence-free survival	—

Secondary

Measure	Time frame
Overall survival Incidence of adverse events from adjuvant chemotherapy Treatment completion rate Total number of administered courses	—

Contacts

Public ContactJunya Kitadani

Wakayama Medical University Hospital

kitadani@wakayama-med.ac.jp+81-73-441-0613

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026