Non-small Cell Lung Cancer
Conditions
Keywords
Non-small cell lung cancer, EGFR-TKI, Erlotinib, Radiotherapy
Brief 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.
Interventions
DRUGErlotinib
Erlotinib 150mg/day
RADIATIONThoracic radiotherapy
60-70Gy/30-35f
Sponsors
Zhejiang Cancer Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tumor response rate (Response was analyzed according to the RECIST system, based on CT scans.) | After the thoracic radiotherapy and concurrent Erlotinib treatment |
| The safety (The safety was evaluated according to the National Cancer Institute Common Toxicity Criteria version 3.0.) | Every one month |
Secondary
| Measure | Time frame |
|---|---|
| Quality of Life (QoL was evaluated according to the FACT-L.) | Every one month |
| Progression free survival | The time from the start of treatment to diease progression |
| The overall survival | The time from the start of treatment to death |
Countries
China
Contacts
Primary ContactShenglin Ma, MD
Backup ContactYaping Xu, MD
Outcome results
None listed