Erlotinib Concurrent With Radiation Therapy in Non-small-cell Lung Cancer
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Carcinoma, Non-Small Cell Lung |
Other: Radiation Therapy and EGFR-TKI target therapy |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
- Evidence of clinically definite disease progression [ Time Frame: 3 year ] [ Designated as safety issue: No ]
- All cause mortality and any grade III and above toxicities [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 50 |
| Study Start Date: | October 2009 |
| Estimated Study Completion Date: | October 2015 |
| Estimated Primary Completion Date: | October 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Combined Treatment arm
All the patients received oral erlotinib and concurrent radiation therapy
|
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)
Other Name: Tarceva, Radiotherapy
|
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| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Lujun Zhao, M.D., Ph.D. | +86-22-23340123 ext 3141 | lujunzhao@yahoo.com |
| Contact: Zhiyong Yuan, M.D., Ph.D. | +86-22-23340123 ext 3131 | lujunzhao@yahoo.com |
| China, Tianjin | |
| Tianjin Medical University Cancer Institute and Hospital, Tianjin Key Laboratory of Cancer Prevention and Therapy | Recruiting |
| Tianjin, Tianjin, China, 300060 | |
| Contact: Zhao Yan +86-22-23340123 ext 5509 yanzhaotj@126.com | |
| Principal Investigator: Xishan Hao, M.D. | |
| Principal Investigator: | Zhiyong Yuan, M.D., Ph.D. | Tianjin Medical University Cancer Institute and Hospital |
More Information
No publications provided
| Responsible Party: | Zhiyong Yuan/Chair of the Department of Radiation Oncology, Tianjin Medical University Cancer Institute and Hospital, and Tianjin Key Laboratory of Cancer Prevention and Therapy. Tianjin, China |
| ClinicalTrials.gov Identifier: | NCT00973310 History of Changes |
| Other Study ID Numbers: | TMU-CIH-L001 |
| Study First Received: | September 8, 2009 |
| Last Updated: | July 19, 2011 |
| Health Authority: | China: Ethics Committee |
Keywords provided by Tianjin Medical University Cancer Institute and Hospital:
|
Non-small-cell lung cancer Radiation therapy Epidermal growth factor receptor Tyrosine kinase inhibitor |
Additional relevant MeSH terms:
|
Carcinoma Carcinoma, Non-Small-Cell Lung Lung Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms |
Thoracic Neoplasms Neoplasms by Site Lung Diseases Respiratory Tract Diseases Erlotinib Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013