A Phase II Trial of Neoadjuvant Chemotherapy for Stage II, III Esophageal Squamous Cell Carcinoma

Sun Yat-sen University1 site in 1 country80 target enrollmentOctober 2016

ConditionsStage II and III Esophageal Squamous Cell Carcinoma

InterventionsDCX surgery

DrugsDCX

Overview

Phase: Phase 2
Intervention: DCX
Conditions: Stage II and III Esophageal Squamous Cell Carcinoma
Sponsor: Sun Yat-sen University
Enrollment: 80
Locations: 1
Primary Endpoint: overall survival rate
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to determine whether docetaxel, cisplatin, and capecitabine (DCX) are effective as the neoadjuvant chemotherapy before esophagectomy in patients with loco-regional esophageal squamous cell carcinoma (ESCC).

Registry

clinicaltrials.gov

Start Date

October 2016

End Date

October 2018

Last Updated

9 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Sun Yat-sen University

Responsible Party

Principal Investigator

Yanhong Deng

MD, PHD

Sun Yat-sen University

Eligibility Criteria

Inclusion Criteria

•Histologic diagnosis of squamous cell thoracic esophageal carcinoma of Stage II or III, which is potentially resectable.
•Patients must not have received any prior anticancer therapy.
•More than 6 months of expected survival.
•Age ranges from 18 to 70 years.
•Absolute white blood cells count ≥4.0×109/L, neutrophil ≥1.5×109/L, platelets ≥100.0×109/L, hemoglobin ≥90g/L, and normal functions of liver and kidney.
•Karnofsky performance status (KPS) of 90 or more.
•Signed informed consent document on file.

Exclusion Criteria

•Patients are diagnosed or suspected to be allergic to docetaxol or cisplatin or capecitabine.
•Patients with concomitant hemorrhagic disease.
•Pregnant or breast feeding.
•Inability to use gastric conduit after esophagectomy because of a prior surgery.
•Patients with concomitant peripheral neuropathy, whose common toxicity criterion (CTC) status is 2 or even more.
•Have a prior malignancy other than esophageal carcinoma, carcinoma in situ of the cervix, nonmelanoma skin cancer or cured early stage of prostate cancer.

Arms & Interventions

DCX and surgery

docetaxol 60mg/m2 iv d1 and cisplatin 30mg/m2 iv d1-2 and capecitabine 850mg/m2 bid po d1-14 repeated every 21 days for 4-6 cycles, followed by surgery of Ivor Lewis Esophagectomy

Intervention: DCX

DCX and surgery

docetaxol 60mg/m2 iv d1 and cisplatin 30mg/m2 iv d1-2 and capecitabine 850mg/m2 bid po d1-14 repeated every 21 days for 4-6 cycles, followed by surgery of Ivor Lewis Esophagectomy

Intervention: surgery