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

Phase 2

Recruiting

• Conditions: esophageal cancer

• Registration Number: JPRN-jRCTs051200048
• Lead Sponsor: Kitadani Junya

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-08-26
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 27

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 <=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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified