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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2010 by Zhejiang Cancer Hospital.
Recruitment status was:  Recruiting
Information provided by:
Zhejiang Cancer Hospital Identifier:
First received: January 14, 2010
Last updated: May 13, 2010
Last verified: March 2010
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.

Condition Intervention Phase
Non-small Cell Lung Cancer Drug: Erlotinib Radiation: Thoracic radiotherapy Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Erlotinib Combined With Radiotherapy in Patients With Non-resectable Locally Advanced Non-small Cell Lung Cancer

Resource links provided by NLM:

Further study details as provided by Zhejiang Cancer Hospital:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Progression free survival [ Time Frame: The time from the start of treatment to diease progression ]
  • The overall survival [ Time Frame: The time from the start of treatment to death ]
  • Quality of Life (QoL was evaluated according to the FACT-L.) [ Time Frame: Every one month ]

Estimated Enrollment: 75
Study Start Date: January 2010
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Concomitant Erlotinib and radiotherapy
Patients received Erlotinib and radiation therapy.
Drug: Erlotinib
Erlotinib 150mg/day
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.

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01091376

Contact: Shenglin Ma, MD +8657188122568
Contact: Yaping Xu, MD +8657188122082

China, Zhejiang
Zhejiang Cancer Hospital Recruiting
Hangzhou, Zhejiang, China, 310022
Contact: Shenglin Ma, MD    +8657188122568   
Contact: Yaping Xu, MD    +8657188122082   
Principal Investigator: Shenglin Ma, MD         
Sub-Investigator: Yaping Xu, MD         
Sponsors and Collaborators
Zhejiang Cancer Hospital
Principal Investigator: Shenglin Ma, MD Zhejiang Cancer Hospital
Principal Investigator: Lvhua Wang, MD Chinese Academy of Medical Sciences
  More Information

Responsible Party: Shenglin Ma, Lvhua Wang, Zhejiang Cancer Hospital; Chinese Academy of Medical Sciences Cancer Hospital Identifier: NCT01091376     History of Changes
Other Study ID Numbers: ZhejiangCH02
Study First Received: January 14, 2010
Last Updated: May 13, 2010

Keywords provided by Zhejiang Cancer Hospital:
Non-small cell lung cancer

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Erlotinib Hydrochloride
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on September 19, 2017