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

This study is currently recruiting participants.
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

September 8, 2009
February 10, 2014
October 2009
October 2014   (final data collection date for primary outcome measure)
Evidence of clinically definite disease progression [ Time Frame: 3 year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00973310 on ClinicalTrials.gov Archive Site
All cause mortality and any grade III and above toxicities [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Erlotinib Concurrent With Radiation Therapy in Non-small-cell Lung Cancer
A Phase II Study on the Safety and Efficacy of Radiation Therapy and Concurrent Erlotinib in Locally Advanced Non-small-cell Lung Cancer

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.

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.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Carcinoma, Non-Small Cell Lung
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
Experimental: Combined Treatment arm
All the patients received oral erlotinib and concurrent radiation therapy
Intervention: Other: Radiation Therapy and EGFR-TKI target therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
October 2015
October 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
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
China
 
NCT00973310
TMU-CIH-L001
No
Tianjin Medical University Cancer Institute and Hospital
Tianjin Medical University Cancer Institute and Hospital
Not Provided
Principal Investigator: Zhiyong Yuan, M.D., Ph.D. Tianjin Medical University Cancer Institute and Hospital
Tianjin Medical University Cancer Institute and Hospital
December 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP