A Phase II Study of Erlotinib Combined With Radiotherapy in Patients With Non-resectable Locally Advanced Non-small Cell Lung Cancer
Overview
- Phase
- Phase 2
- Intervention
- Erlotinib
- Conditions
- Non-small Cell Lung Cancer
- Sponsor
- Zhejiang Cancer Hospital
- Enrollment
- 75
- Locations
- 1
- Primary Endpoint
- Tumor response rate (Response was analyzed according to the RECIST system, based on CT scans.)
- Last Updated
- 15 years ago
Overview
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.
Investigators
Eligibility 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
Arms & Interventions
Concomitant Erlotinib and radiotherapy
Patients received Erlotinib and radiation therapy.
Intervention: Erlotinib
Concomitant Erlotinib and radiotherapy
Patients received Erlotinib and radiation therapy.
Intervention: Thoracic radiotherapy
Outcomes
Primary Outcomes
Tumor response rate (Response was analyzed according to the RECIST system, based on CT scans.)
Time Frame: 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.)
Time Frame: Every one month
Secondary Outcomes
- 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)
- Quality of Life (QoL was evaluated according to the FACT-L.)(Every one month)