A Randomized Phase III Study: Paclitaxel Plus Radiation Therapy With or Without Erlotinib in Treating Patients With Esophageal Squamous Carcinoma

The Affiliated Hospital of the Chinese Academy of Military Medical Sciences1 site in 1 country120 target enrollmentNovember 2012

ConditionsEsophageal Squamous Carcinoma

InterventionsPaclitaxel Radiation therapy Erlotinib

DrugsPaclitaxel Erlotinib

Overview

Phase: Phase 3
Intervention: Paclitaxel
Conditions: Esophageal Squamous Carcinoma
Sponsor: The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
Enrollment: 120
Locations: 1
Primary Endpoint: Progression free survival
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to test the safety and effectiveness of erlotinib and chemoradiotherapy in patients with unresectable esophageal or gastro-esophageal squamous cancer .

Registry

clinicaltrials.gov

Start Date

November 2012

End Date

November 2014

Last Updated

13 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

The Affiliated Hospital of the Chinese Academy of Military Medical Sciences

Responsible Party

Principal Investigator

Xu jianming

The Affiliated Hospital of the Chinese Academy of Military Medical Sciences

Eligibility Criteria

Inclusion Criteria

•Histologically confirmed squamous cell carcinoma of esophagus or Esophagogastric Junction
•ECOG PS 0-2
•Ineligibility for surgery
•No prior palliative therapy
•At least one bidimensionally measurable disease as defined by RECIST ver 1.1
•Adequate organ function for treatment
•Absolute neutrophil count (ANC)\>=1000cells/mm3
•Platelets \>=100000 cells/mm3
•Estimated creatinine clearance\>=50mL/min, or serum creatinine\<1.5 x institution upper limit of normal
•Bilirubin=\<1.5 x upper limit of normal(ULN)

Exclusion Criteria

•Previous treatment with small molecule EGFR tyrosine kinase inhibitors
•Any major operation within 4 weeks of baseline disease assessment
•Any clinically significant gastrointestinal abnormalities which may impair intake or absorption of the study drug
•CNS metastasis with continuous corticosteroid use within 4 weeks of baseline disease assessment
•Patients with known interstitial lung disease
•Patients with uncontrolled or significant cardiovascular disease (AMI within 12 months,Unstable angina within 6 months, NYHA Class III, IV Congestive heart failure or left ventricular ejection fraction below local institutional lower limit of normal or below 45%, Congenital long QT syndrome, Any significant ventricular arrhythmia, Any uncontrolled second or third degree heart block, Uncontrolled hypertension)
•Previous or concurrent malignancy except for basal or squamous cell skin cancer and/or in situ carcinoma of the cervix, or other solid tumors treated curatively and without evidence of recurrence for at least 5 years prior to study entry.
•Pregnant or breast-feeding women
•Other severe acute or chronic medical condition or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of trial results and, in the judgment of the investigator, would make the patient inappropriate for entry into this trial.