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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2010 by Tianjin Medical University Cancer Institute and Hospital.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
Tianjin Medical University Cancer Institute and Hospital Identifier:
First received: September 8, 2009
Last updated: December 21, 2015
Last verified: December 2010
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
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 ]

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

Estimated Enrollment: 50
Study Start Date: October 2009
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: November 2016 (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.

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 identifier: NCT00973310

Contact: Lujun Zhao, M.D., Ph.D. +86-22-23340123 ext 3141
Contact: Zhiyong Yuan, M.D., Ph.D. +86-22-23340123 ext 3131

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   
Principal Investigator: Xishan Hao, M.D.         
Sponsors and Collaborators
Tianjin Medical University Cancer Institute and Hospital
Principal Investigator: Zhiyong Yuan, M.D., Ph.D. Tianjin Medical University Cancer Institute and Hospital
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Tianjin Medical University Cancer Institute and Hospital Identifier: NCT00973310     History of Changes
Other Study ID Numbers: TMU-CIH-L001
Study First Received: September 8, 2009
Last Updated: December 21, 2015

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:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Erlotinib Hydrochloride
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on April 28, 2017