Erlotinib Combined With Radiotherapy in Patients With Non-resectable Locally Advanced Non-small Cell Lung Cancer (LA-NSCLC)

Non-small Cell Lung Cancer Clinical Trial

— RT0901  

Official title:

A Phase II Study of Erlotinib Combined With Radiotherapy in Patients With Non-resectable Locally Advanced Non-small Cell Lung Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01091376
• Other study ID #: ZhejiangCH02
• Status: Recruiting
• Phase: Phase 2
• First received: January 14, 2010
• Last updated: May 13, 2010
• Start date: January 2010
• Est. completion date: March 2013

Study information

• Verified date: March 2010
• Source: Zhejiang Cancer Hospital
• Contact: Shenglin Ma, MD
• Phone: +8657188122568
• Email: mashenglin[@]medmail.com.cn
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: March 2013
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

Intervention

Drug:
• Erlotinib
Erlotinib 150mg/day

Radiation:
• Thoracic radiotherapy
60-70Gy/30-35f

Locations

Country	Name	City	State
China	Zhejiang Cancer Hospital	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Zhejiang Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tumor response rate (Response was analyzed according to the RECIST system, based on CT scans.)		After the thoracic radiotherapy and concurrent Erlotinib treatment	Yes
Primary	The safety (The safety was evaluated according to the National Cancer Institute Common Toxicity Criteria version 3.0.)		Every one month	No
Secondary	Progression free survival		The time from the start of treatment to diease progression	Yes
Secondary	The overall survival		The time from the start of treatment to death	Yes
Secondary	Quality of Life (QoL was evaluated according to the FACT-L.)		Every one month	Yes