Paclitaxel Plus Radiation With Erlotinib to Treat Esophageal Squamous Carcinoma
NCT ID: NCT01752205
Last Updated: 2012-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
120 participants
INTERVENTIONAL
2012-11-30
2014-11-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Chemoradiotherapy
The patients will receive radiation therapy QD, 5 days a week and receive paclitaxel IV ，dosing schedule: 45mg/m2/w.
Paclitaxel
45mg/m2/w,total 6 weeks
Radiation therapy
Erlotinib and chemoradiotherapy
The patients will receive radiation therapy QD, 5 days a week and receive paclitaxel IV (45mg/m2/w) and erlotinib PO QD.
Paclitaxel
45mg/m2/w,total 6 weeks
Erlotinib
150mg/d,days 1-42,total 6 weeks
Radiation therapy
Interventions
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Paclitaxel
45mg/m2/w,total 6 weeks
Erlotinib
150mg/d,days 1-42,total 6 weeks
Radiation therapy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Age \>= 18
3. ECOG PS 0-2
4. Ineligibility for surgery
5. No prior palliative therapy
6. At least one bidimensionally measurable disease as defined by RECIST ver 1.1
7. 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%.
8. The patient has provided signed informed consent and is amenable to compliance with protocol schedules and testing.
Exclusion Criteria
2. Any major operation within 4 weeks of baseline disease assessment
3. Any clinically significant gastrointestinal abnormalities which may impair intake or absorption of the study drug
4. CNS metastasis with continuous corticosteroid use within 4 weeks of baseline disease assessment
5. Patients with known interstitial lung disease
6. 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)
7. 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.
8. Pregnant or breast-feeding women
9. 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.
18 Years
ALL
No
Sponsors
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The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
OTHER
Responsible Party
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Xu jianming
The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
Principal Investigators
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Xu jianming, M.D.
Role: PRINCIPAL_INVESTIGATOR
The Affiliated Hospital of the Chinese Academy of Military Medical Science
Locations
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307 Hospital of PLA
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Xu jianming, M.D.
Role: primary
Zhao chuanhua
Role: backup
Other Identifiers
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ESCC-307PLAH-XJM
Identifier Type: -
Identifier Source: org_study_id