Erlotinib Concurrent With Radiation Therapy in Non-small-cell Lung Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2010 by Tianjin Medical University Cancer Institute and Hospital
Sponsor:
Information provided by (Responsible Party):
Tianjin Medical University Cancer Institute and Hospital
ClinicalTrials.gov Identifier:
NCT00973310
First received: September 8, 2009
Last updated: February 10, 2014
Last verified: December 2010
  Purpose

The purpose of this study is to determine the safety and efficacy of the concurrent use of erlotinib and radiation therapy in the treatment of locally advanced non-small lung cancer.


Condition Intervention Phase
Carcinoma, Non-Small Cell Lung
Other: Radiation Therapy and EGFR-TKI target therapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study on the Safety and Efficacy of Radiation Therapy and Concurrent Erlotinib in Locally Advanced Non-small-cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by Tianjin Medical University Cancer Institute and Hospital:

Primary Outcome Measures:
  • Evidence of clinically definite disease progression [ Time Frame: 3 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • All cause mortality and any grade III and above toxicities [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 50
Study Start Date: October 2009
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Combined Treatment arm
All the patients received oral erlotinib and concurrent radiation therapy
Other: Radiation Therapy and EGFR-TKI target therapy
Patients with locally advanced NSCLC received oral erlotinib (150 mg, qd) for about 6-7 weeks during the course of radiation therapy (60-70Gy in a fraction dose of 2 Gy, 5 fractions per week)
Other Name: Tarceva, Radiotherapy

Detailed Description:

Non-small cell lung cancer (NSCLC) is still the leading cause of cancer death world-wide. Radiation therapy (RT) is one of the most important treatment choices in locally advanced NSCLC. Combination of RT and chemotherapy could improve treatment outcomes. However, the combined modality could not be used in many patients due to severe toxicities. EGFR-TKI shows great efficacy in the treatment of NSCLC, and many phase I/II studies established its safety in combination with RT. This phase II study is to further evaluate the efficacy and safety of the combination of RT and erlotinib in the treatment of locally advanced NSCLC. Eligible patients include patients with stage IIIA/IIIB NSCLC, who are not suitable for or refused to receive concurrent chemoradiotherapy. Eligible patients will receive oral erlotinib (150mg qd)throughout the course of thoracic RT (60-70 Gy). The primary endpoint is progression free survival and the second endpoints are overall survival and any grade III and above toxicities. We are going to recruit 50 patients for this study.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Aged 18-70 years,
  • Patients with stage IIIA-IIIB NSCLC
  • adequate hematologic (WBC and platelet counts within normal limits), hepatic (total bilirubin level <= two times the upper limit of normal), and renal (creatinine clearance >= 50mL/min) functions
  • No history of chemotherapy or less than 4 cycles neoadjuvant chemotherapy
  • Can not tolerate or refuse concurrent chemoradiotherapy
  • No history of thoracic RT
  • Written informed consent obtained

Exclusion Criteria:

  • With other malignancy
  • With severe cardiopulmonary disease
  • Compromised liver or renal function that could not tolerate the combined therapy
  • Received thoracic RT before
  • Pregnant or breast-feeding women
  • Present with active infection
  • Uncontrolled diabetes
  • Concurrent use of other anti-cancer agents
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00973310

Contacts
Contact: Lujun Zhao, M.D., Ph.D. +86-22-23340123 ext 3141 lujunzhao@yahoo.com
Contact: Zhiyong Yuan, M.D., Ph.D. +86-22-23340123 ext 3131 lujunzhao@yahoo.com

Locations
China, Tianjin
Tianjin Medical University Cancer Institute and Hospital, Tianjin Key Laboratory of Cancer Prevention and Therapy Recruiting
Tianjin, Tianjin, China, 300060
Contact: Zhao Yan    +86-22-23340123 ext 5509    yanzhaotj@126.com   
Principal Investigator: Xishan Hao, M.D.         
Sponsors and Collaborators
Tianjin Medical University Cancer Institute and Hospital
Investigators
Principal Investigator: Zhiyong Yuan, M.D., Ph.D. Tianjin Medical University Cancer Institute and Hospital
  More Information

No publications provided

Responsible Party: Tianjin Medical University Cancer Institute and Hospital
ClinicalTrials.gov Identifier: NCT00973310     History of Changes
Other Study ID Numbers: TMU-CIH-L001
Study First Received: September 8, 2009
Last Updated: February 10, 2014
Health Authority: China: Ethics Committee

Keywords provided by Tianjin Medical University Cancer Institute and Hospital:
Non-small-cell lung cancer
Radiation therapy
Epidermal growth factor receptor
Tyrosine kinase inhibitor

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Erlotinib
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 23, 2014