Erlotinib Combined With Radiotherapy in Patients With Non-resectable Locally Advanced Non-small Cell Lung Cancer (LA-NSCLC)
Conditions
Non-small Cell Lung Cancer
Conditions: official terms
Carcinoma, Non-Small-Cell Lung - Lung Neoplasms
Conditions: Keywords
Non-small cell lung cancer, EGFR-TKI, Erlotinib, Radiotherapy
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Erlotinib Type: Drug
Name: Thoracic radiotherapy Type: Radiation
Overall Status
Recruiting
Summary
Concomitant chemoradiotherapy is the standard treatment of locally advanced,non-resectable, non-small cell lung cancer (NSCLC). However,the optimal chemotherapy regimen is still controversial.The objective of this study was to evaluate the efficacy and toxicity of a concomitant treatment using Erlotinib and radiotherapy followed by Erlotinib consolidation treatment.
Detailed Description
Patients with non-resectable Non-small Cell Lung Cancer will receive thoracic radiation therapy 60-70 Gy over 30-35 fractions and concurrent with Erlotinib 150mg/day. Followed by Erlotinib 150 mg/day consolidation treatment.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 75 Years
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- Histologically proven non-small cell lung cancer (squamous cell carcinoma, adenocarcinoma, large cell carcinoma and etc)

- Tumor EGFR mutation

- Presence of measurable disease by RECIST

- stage IIIA or IIIB, non-resectable

- ECOG performance status 0-2

- No prior chemotherapy, radiation therapy to chest, immunotherapy, or biologic therapy

- Patients must sign an informed consent indicating that they are aware of the investigational nature of the study in keeping with the policy of the hospital.

Exclusion Criteria:

- Carcinoid tumor, small cell carcinoma of lung

- Patients with any distant metastasis

- History of another malignancy except cured basal cell carcinoma of skin and cured carcinoma in-situ of uterine cervix

- Any other morbidity or situation with contraindication for radiotherapy (e.g. active infection, myocardial infarction preceding 6 months, symptomatic heart disease including unstable angina, congestive heart failure or uncontrolled arrhythmias, immunosuppressive treatment)

- Pregnant or lactating women, women who has not taken test of pregnancy (within 7 days before the first administration) and pregnant women

- Women and men of childbearing potential who have no willing of employing adequate contraception

- Tumor EGFR wild
Location
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Status: Recruiting
Contact: Shenglin Ma, MD - +8657188122568 - mashenglin@medmail.com.cn
Start Date
January 2010
Completion Date
March 2013
Sponsors
Zhejiang Cancer Hospital
Source
Zhejiang Cancer Hospital
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page