Paclitaxel Plus Radiation With Erlotinib to Treat Esophageal Squamous Carcinoma (ESCC-307PLAH)

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

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 .

Study Overview

• Status: Unknown
• Conditions: Esophageal Squamous Carcinoma
• Intervention / Treatment: Radiation: Radiation therapy; Drug: Paclitaxel; Drug: Erlotinib

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China
      • Recruiting
      • 307 Hospital of PLA
      • Sub-Investigator: Zhao chuanhua

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Progression free survival	2 year

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: The Affiliated Hospital of the Chinese Academy of Military Medical Sciences

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (Anticipated): May 1, 2014
• Study Completion (Anticipated): November 1, 2014

Study Registration Dates

• First Submitted: December 16, 2012
• First Submitted That Met QC Criteria: December 16, 2012
• First Posted (Estimate): December 19, 2012

Study Record Updates

• Last Update Posted (Estimate): December 19, 2012
• Last Update Submitted That Met QC Criteria: December 16, 2012
• Last Verified: December 1, 2012

More Information

Terms related to this study

• Keywords: Erlotinib; Chemoradiotherapy; Esophageal Squamous Carcinoma
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Squamous Cell; Carcinoma; Carcinoma, Squamous Cell; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Protein Kinase Inhibitors; Paclitaxel; Erlotinib Hydrochloride
• Other Study ID Numbers: ESCC-307PLAH-XJM