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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00973310

Enrollment

Registered

2009-09-09

Start date

2009-10-31

Completion date

2016-12-31

Last updated

2015-12-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carcinoma, Non-Small Cell Lung

Keywords

Non-small-cell lung cancer, Radiation therapy, Epidermal growth factor receptor, Tyrosine kinase inhibitor

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.

Interventions

OTHERRadiation 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)

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Evidence of clinically definite disease progression	3 year

Secondary

Measure	Time frame
All cause mortality and any grade III and above toxicities	3 years

Countries

China

Contacts

Primary ContactLujun Zhao, M.D., Ph.D.

lujunzhao@yahoo.com+86-22-23340123

Backup ContactZhiyong Yuan, M.D., Ph.D.