Prospective trial to evaluate the safety and efficacy to treat esophageal cancer using 5-FU, Oxaliplatin, and Docetaxel

Phase 2

Active, not recruiting

• Conditions: Esophageal squamous cell carcinoma

• Registration Number: JPRN-jRCTs031200094
• Lead Sponsor: Kawakubo Hirofumi

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-08-24
• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Histologically diagnosed as esophageal squamous cell carcinoma (squamous, adenosquamous, basaloid)
2. Primary tumor is located mainly in the thoracic esophagus
3. cT1N1-3M0-1 (only supraclavicular LN metastasis is included as M1), cT2-3N0-3M0-1 (only supraclavicular LN metastasis is included as M1)
4. Twenty years old or older as of registration
5. Performance status (PS) 0 or 1
6. Patients have target lesions
7. No previous history of esophageal cancer except for the followings
1) pT1a-LPM (M2) or deeper following EMR/ESD
2) pT1a-MM (M3) with vascular invasion following EMR/ ESD
8. No previous history of chemotherapy/radiotherapy/endocrine therapy except for hormone therapy for prostate cancer after 5 years interval
9. Patients who meet the following criteria
1) Neutrophil>1,500 /mm3
2) Platelet>10.0x10^4 /mm3
3) Hb>=9.0 g/dL
4) Total bilirubin<=1.5 mg/dL
5) AST<=100 IU/L
6) ALT<=100 IU/L
7) SpO2>=95 %
8) Creatinine clearance<=50 mL/min
10. Patients who can undergo esophagectomy
11. Agree with the participation to the current study

Exclusion Criteria

1. Patients who received any treatment for cancer within 3 years
2. Patients who have active infectious diseases
3. HBs Ag positive or HIV Ab positive
4. Pregnant or breast feeding
5. Patients with psychological disorder
6. On systemic steroid therapy
7. Require flucytocine, phenytoin, warfarin
8. Allergic to iodine
9. Allergic to DTX, LOHP, polisorbate 80
10. Uncontrollable diabetes
11. Severe COPD or lung fibrosis
12. Severe hypertension
13. Unstable angina
14. Patients whom investigators evaluate as ineligible

Study & Design

• Study Type: Interventional
• Study Design: Not specified