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

NCT ID: NCT00973310

Last Updated: 2015-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2016-12-31

Brief Summary

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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

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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.

Conditions

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Carcinoma, Non-Small Cell Lung

Keywords

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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Combined Treatment arm

All the patients received oral erlotinib and concurrent radiation therapy

Group Type EXPERIMENTAL

Radiation Therapy and EGFR-TKI target therapy

Intervention Type OTHER

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)

Interventions

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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)

Intervention Type OTHER

Other Intervention Names

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Tarceva, Radiotherapy

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tianjin Medical University Cancer Institute and Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Zhiyong Yuan, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Tianjin Medical University Cancer Institute and Hospital

Locations

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Tianjin Medical University Cancer Institute and Hospital, Tianjin Key Laboratory of Cancer Prevention and Therapy

Tianjin, Tianjin Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Lujun Zhao, M.D., Ph.D.

Role: CONTACT

Phone: +86-22-23340123

Email: [email protected]

Zhiyong Yuan, M.D., Ph.D.

Role: CONTACT

Phone: +86-22-23340123

Email: [email protected]

Facility Contacts

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Zhao Yan

Role: primary

References

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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.

Reference Type DERIVED
PMID: 24920921 (View on PubMed)

Other Identifiers

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TMU-CIH-L001

Identifier Type: -

Identifier Source: org_study_id