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

This study is currently recruiting participants.
Verified December 2012 by The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
Sponsor:
Information provided by (Responsible Party):
Xu jianming, The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
ClinicalTrials.gov Identifier:
NCT01752205
First received: December 16, 2012
Last updated: NA
Last verified: December 2012
History: No changes posted
  Purpose

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 .


Condition Intervention Phase
Esophageal Squamous Carcinoma
Drug: Paclitaxel
Drug: Erlotinib
Radiation: Radiation therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Phase III Study: Paclitaxel Plus Radiation Therapy With or Without Erlotinib in Treating Patients With Esophageal Squamous Carcinoma

Resource links provided by NLM:


Further study details as provided by The Affiliated Hospital of the Chinese Academy of Military Medical Sciences:

Primary Outcome Measures:
  • Progression free survival [ Time Frame: 2 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Tumor response rate [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • disease control rate [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • overall survival [ Time Frame: 5 year ] [ Designated as safety issue: Yes ]
  • adverse events [ Time Frame: 5 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 120
Study Start Date: November 2012
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Chemoradiotherapy
The patients will receive radiation therapy QD, 5 days a week and receive paclitaxel IV ,dosing schedule: 45mg/m2/w.
Drug: Paclitaxel
45mg/m2/w,total 6 weeks
Radiation: Radiation therapy
Other Name: radiation therapy QD, 5 days a week,95%PTV 60Gy/2Gy/30f,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.
Drug: Paclitaxel
45mg/m2/w,total 6 weeks
Drug: Erlotinib
150mg/d,days 1-42,total 6 weeks
Radiation: Radiation therapy
Other Name: radiation therapy QD, 5 days a week,95%PTV 60Gy/2Gy/30f,total 6 weeks

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01752205

Contacts
Contact: Xu jianming, M.D. 861051128358 jmxu2003@yahoo.com

Locations
China, Beijing
307 Hospital of PLA Recruiting
Beijing, Beijing, China
Contact: Xu jianming, M.D.    86-10-66947176    jmxu2003@yahoo.com   
Contact: Zhao chuanhua    86-10-66947179    chuanhuazhao@163.com   
Sub-Investigator: Zhao chuanhua         
Sponsors and Collaborators
The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
Investigators
Principal Investigator: Xu jianming, M.D. The Affiliated Hospital of the Chinese Academy of Military Medical Science
  More Information

No publications provided

Responsible Party: Xu jianming, The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
ClinicalTrials.gov Identifier: NCT01752205     History of Changes
Other Study ID Numbers: ESCC-307PLAH-XJM
Study First Received: December 16, 2012
Last Updated: December 16, 2012
Health Authority: China: Ethics Committee

Keywords provided by The Affiliated Hospital of the Chinese Academy of Military Medical Sciences:
Esophageal Squamous Carcinoma
Erlotinib
Chemoradiotherapy

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Paclitaxel
Erlotinib
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Protein Kinase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on April 14, 2014