Clinical trial NCT01752205: Paclitaxel Plus Radiation With Erlotinib to Treat Esophageal Squamous Carcinoma
Official title: A Randomized Phase III Study: Paclitaxel Plus Radiation Therapy With or Without Erlotinib in Treating Patients With Esophageal Squamous Carcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Esophageal Squamous Carcinoma
Keywords: Esophageal Squamous Carcinoma
Erlotinib
Chemoradiotherapy
Lead sponsor: The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
Sponsor class: OTHER
First posted: 2012-12-19
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 .


Eligibility criteria: Inclusion Criteria:

1. Histologically confirmed squamous cell carcinoma of esophagus or Esophagogastric Junction
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:

1. Previous treatment with small molecule EGFR tyrosine kinase inhibitors
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.

Primary outcomes:
measure: Progression free survival
timeFrame: 2 year
Secondary outcomes:
measure: Tumor response rate
timeFrame: 1 year
measure: disease control rate
timeFrame: 1 year
measure: overall survival
timeFrame: 5 year
measure: adverse events
timeFrame: 5 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: 307 Hospital of PLA
state: Beijing
Study officials:
affiliation: The Affiliated Hospital of the Chinese Academy of Military Medical Science
name: Xu jianming, M.D.
role: PRINCIPAL_INVESTIGATOR
References: