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

JRCT ID: jRCTs051200048

Registered date:26/08/2020

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: esophageal cancer
• Date of first enrollment: 08/12/2020
• Target sample size: 27
• Study type: Interventional
• Intervention(s): 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 courses of docetaxel + cisplatin + S-1 (DCS therapy) as preoperative adjuvant chemotherapy and underwent curative esophagectomy.

Outcome(s)

• Primary Outcome: Recurrence-free survival

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 80age old
• Gender: Both

Include 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 <=2.0 mg/dL
5. AST<=100U/L
6. ALT<=100 U/L
7. Serum creatinine <=1.5 mg/dL
8. Creatinine clearance>=40 mL/min
(11) Informed consent has been obtained

Exclude 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

Related Information

• Primary Sponsor: Kitadani Junya