Paclitaxel Plus Radiation With Erlotinib to Treat Esophageal Squamous Carcinoma

Study Overview
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Brief Summary
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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 .

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

Conditions
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Esophageal Squamous Carcinoma

Intervention / Treatment
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* Drug: Paclitaxel
* Drug: Erlotinib
* Radiation: Radiation therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically confirmed squamous cell carcinoma of esophagus or Esophagogastric Junction Age >= 18 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) AST(SGOT)=<2.5 x ULN (5.0xULN if hepatic metastases) ALT(SGPT)=<2.5 x ULN (5.0xULN if hepatic metastases) 12-Lead electrocardiogram(ECG) with normal tracing or non-clinically significant changes that do not require medical intervention QTc interval =<470 msec and without history of Torsades de Points or other symptomatic QTc abnormality LVEF (by MUGA or echocardiogram) of >=50%. The patient has provided signed informed consent and is amenable to compliance with protocol schedules and testing. 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Chemoradiotherapy<br>The patients will receive radiation therapy QD, 5 days a week and receive paclitaxel IV ，dosing schedule: 45mg/m2/w. | Drug: Paclitaxel<br>* 45mg/m2/w,total 6 weeks<br>Radiation: Radiation therapy<br> <br> * Other names: radiation therapy QD, 5 days a week,95%PTV 60Gy/2Gy/30f,total 6 weeks;|
| Experimental: Erlotinib and chemoradiotherapy<br>The patients will receive radiation therapy QD, 5 days a week and receive paclitaxel IV (45mg/m2/w) and erlotinib PO QD. | Drug: Paclitaxel<br>* 45mg/m2/w,total 6 weeks<br>Drug: Erlotinib<br>* 150mg/d,days 1-42,total 6 weeks<br>Radiation: Radiation therapy<br> <br> * Other names: radiation therapy QD, 5 days a week,95%PTV 60Gy/2Gy/30f,total 6 weeks;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival |  | 2 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumor response rate |  | 1 year | 
| disease control rate |  | 1 year | 
| overall survival |  | 5 year | 
| adverse events |  | 5 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Esophageal Squamous Carcinoma, Erlotinib, Chemoradiotherapy