Erlotinib Combined With Radiotherapy in Patients With Non-resectable Locally Advanced Non-small Cell Lung Cancer (LA-NSCLC) (RT0901)

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

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.

Study Overview

• Status: Unknown
• Conditions: Non-small Cell Lung Cancer
• Intervention / Treatment: Drug: Erlotinib; Radiation: Thoracic radiotherapy

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.

• Study Type: Interventional
• Enrollment (Anticipated): 75
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310022
      • Recruiting
      • Zhejiang Cancer Hospital
      • Contact: Shenglin Ma, MD; Phone Number: +8657188122568; Email: mashenglin@medmail.com.cn
      • Contact: Yaping Xu, MD; Phone Number: +8657188122082; Email: xuyaping1207@gmail.com
      • Principal Investigator: Shenglin Ma, MD
      • Sub-Investigator: Yaping Xu, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Concomitant Erlotinib and radiotherapy; Patients received Erlotinib and radiation therapy.	Drug: Erlotinib; Erlotinib 150mg/day; Radiation: Thoracic radiotherapy; 60-70Gy/30-35f

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Zhejiang Cancer Hospital
• Investigators: Principal Investigator: Shenglin Ma, MD, Zhejiang Cancer Hospital; Principal Investigator: Lvhua Wang, MD, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Anticipated): December 1, 2010
• Study Completion (Anticipated): March 1, 2013

Study Registration Dates

• First Submitted: January 14, 2010
• First Submitted That Met QC Criteria: March 21, 2010
• First Posted (Estimate): March 24, 2010

Study Record Updates

• Last Update Posted (Estimate): May 17, 2010
• Last Update Submitted That Met QC Criteria: May 13, 2010
• Last Verified: March 1, 2010

More Information

Terms related to this study

• Keywords: Non-small cell lung cancer; Radiotherapy; Erlotinib; EGFR-TKI
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Erlotinib Hydrochloride
• Other Study ID Numbers: ZhejiangCH02