Paclitaxel Plus Radiation With Erlotinib to Treat Esophageal Squamous Carcinoma

NCT01752205 | Unknown Phase 3 DMC

• 1 other identifier: ESCC-307PLAH-XJM
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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 .

Conditions

Esophageal Squamous Carcinoma

Keywords

Esophageal Squamous Carcinoma; Erlotinib; Chemoradiotherapy

Outcome Measures

Primary Outcomes (1)

• Progression free survival

  2 year

Secondary Outcomes (4)

• Tumor response rate

  1 year

• disease control rate

  1 year

• overall survival

  5 year

• adverse events

  5 year

Study Arms (2)

Chemoradiotherapy

ACTIVE COMPARATOR

The patients will receive radiation therapy QD, 5 days a week and receive paclitaxel IV ，dosing schedule: 45mg/m2/w.

Drug: Paclitaxel; Radiation: Radiation therapy

Erlotinib and chemoradiotherapy

EXPERIMENTAL

The patients will receive radiation therapy QD, 5 days a week and receive paclitaxel IV (45mg/m2/w) and erlotinib PO QD.

Drug: Paclitaxel; Drug: Erlotinib; Radiation: Radiation therapy

Interventions

Paclitaxel DRUG

45mg/m2/w,total 6 weeks

Chemoradiotherapy; Erlotinib and chemoradiotherapy

Erlotinib DRUG

150mg/d,days 1-42,total 6 weeks

Erlotinib and chemoradiotherapy

Radiation therapy RADIATION

Also known as: radiation therapy QD, 5 days a week,95%PTV 60Gy/2Gy/30f,total 6 weeks

Chemoradiotherapy; Erlotinib and chemoradiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

307 Hospital of PLA

Beijing, Beijing Municipality, China

RECRUITING

MeSH Terms

Interventions

Paclitaxel; Erlotinib Hydrochloride; Radiotherapy

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Therapeutics

Study Officials

• Xu jianming, M.D.

  The Affiliated Hospital of the Chinese Academy of Military Medical Science

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xu jianming, M.D.

CONTACT

861051128358; jmxu2003@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: The Affiliated Hospital of the Chinese Academy of Military Medical Sciences

Study Record Dates

• First Submitted: December 16, 2012
• First Posted: December 19, 2012
• Study Start: November 1, 2012
• Primary Completion: May 1, 2014
• Study Completion: November 1, 2014
• Last Updated: December 19, 2012

Record last verified: 2012-12

Locations

CN (1)