Docetaxel and S-1 for Advanced Esophageal Cancer

• Status: Unknown status
• Trial end date: 2018-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will evaluate the efficacy of docetaxel and S-1 combination chemotherapy in Korean patients with esophageal cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hallym University Medical Center
• Collaborator: Jeil Pharmaceutical Co., Ltd.
• Treatments: Docetaxel

Criteria

Inclusion Criteria:

• Pathologically confirmed squamous cell carcinoma or adenocarcinoma of esophagus.

• Unresectable locally advanced, recurrent or metastatic disease.

• Measurable or evaluable disease by RECIST criteria 1.1.

• Minimum age of 18 years.

• ECOG Performance status 0-2.

• Prior chemotherapy is not allowed.

• More than 4 weeks since completion of prior radiotherapy (measurable or evaluable lesions are outside the radiation field)

• Adequate organ functions

• Patients must sign an informed consent indicating that they are aware of the investigational nature of the study in keeping with the policy of the hospital

Exclusion Criteria:

• Other tumor type than squamous cell carcinoma and adenocarcinoma

• Previous history of chemotherapy except neoadjuvant or adjuvant chemotherapy without docetaxel and S-1

• Obvious bowel obstruction unrelieved by proper management

• Evidence of serious gastrointestinal bleeding

• Patients with CNS metastases

• Patients with active infection, severe heart disease, uncontrollable hypertension or diabetes mellitus, myocardial infarction during the preceding 6 months, pregnancy, or breast feeding

• Any previous or concurrent malignancy other than non-melanoma skin cancer or in situ cancer of uterine cervix

• Known history of cerebral or leptomeningeal metastases or neurologic disease