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

Carcinoma, Non-Small Cell Lung Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00973310
• Other study ID #: TMU-CIH-L001
• Status: Recruiting
• Phase: Phase 2
• First received: September 8, 2009
• Last updated: December 21, 2015
• Start date: October 2009
• Est. completion date: December 2016

Study information

• Verified date: December 2010
• Source: Tianjin Medical University Cancer Institute and Hospital
• Contact: Lujun Zhao, M.D., Ph.D.
• Phone: +86-22-23340123
• Email: lujunzhao[@]yahoo.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small Cell Lung
• Carcinoma, Non-Small-Cell Lung

Intervention

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)

Locations

Country	Name	City	State
China	Tianjin Medical University Cancer Institute and Hospital, Tianjin Key Laboratory of Cancer Prevention and Therapy	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Tianjin Medical University Cancer Institute and Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evidence of clinically definite disease progression		3 year	No
Secondary	All cause mortality and any grade III and above toxicities		3 years	Yes