Erlotinib Concurrent With Radiation Therapy in Non-small-cell Lung Cancer
Conditions
Carcinoma, Non-Small Cell Lung
Conditions: official terms
Carcinoma, Non-Small-Cell Lung
Conditions: Keywords
Non-small-cell lung cancer, Radiation therapy, Epidermal growth factor receptor, Tyrosine kinase inhibitor
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Radiation Therapy and EGFR-TKI target therapy
Type: Other
Overall Status
Recruiting
Summary
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.
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 70 Years
Minimum Age: 18 Years
Gender: Both
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
Location
Tianjin Medical University Cancer Institute and Hospital, Tianjin Key Laboratory of Cancer Prevention and Therapy
Tianjin, Tianjin, China
Status: Recruiting
Contact: Zhao Yan - +86-22-23340123 - yanzhaotj@126.com
Start Date
October 2009
Completion Date
October 2015
Sponsors
Tianjin Medical University Cancer Institute and Hospital
Source
Tianjin Medical University Cancer Institute and Hospital
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page