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

Tianjin Medical University

Status and phase: Unknown; Phase 2

Conditions: Carcinoma, Non-Small Cell Lung

Treatments: Other: Radiation Therapy and EGFR-TKI target therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT00973310

TMU-CIH-L001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Combined Treatment arm

Experimental group

Description:

All the patients received oral erlotinib and concurrent radiation therapy

Treatment:

Other: Radiation Therapy and EGFR-TKI target therapy