Clinical trial NCT00973310: Erlotinib Concurrent With Radiation Therapy in Non-small-cell Lung Cancer
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Carcinoma, Non-Small Cell Lung
Keywords: Non-small-cell lung cancer
Radiation therapy
Epidermal growth factor receptor
Tyrosine kinase inhibitor
Lead sponsor: Tianjin Medical University Cancer Institute and Hospital
Sponsor class: OTHER
First posted: 2009-09-09
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Eligibility 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

Primary outcomes:
measure: Evidence of clinically definite disease progression
timeFrame: 3 year
Secondary outcomes:
measure: All cause mortality and any grade III and above toxicities
timeFrame: 3 years
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute and Hospital, Tianjin Key Laboratory of Cancer Prevention and Therapy
state: Tianjin
Study officials:
affiliation: Tianjin Medical University Cancer Institute and Hospital
name: Zhiyong Yuan, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zhuang H, Hou H, Yuan Z, Wang J, Pang Q, Zhao L, Wang P. Preliminary analysis of the risk factors for radiation pneumonitis in patients with non-small-cell lung cancer treated with concurrent erlotinib and thoracic radiotherapy. Onco Targets Ther. 2014 May 24;7:807-13. doi: 10.2147/OTT.S62707. eCollection 2014.