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 because the information has not been verified recently.
Verified March 2010 by Zhejiang Cancer Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Zhejiang Cancer Hospital
ClinicalTrials.gov Identifier:
NCT01091376
First received: January 14, 2010
Last updated: May 13, 2010
Last verified: March 2010
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]
  • The safety (The safety was evaluated according to the National Cancer Institute Common Toxicity Criteria version 3.0.) [ Time Frame: Every one month ] [ Designated as safety issue: No ]

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

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
60-70Gy/30-35f

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  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 ClinicalTrials.gov identifier: NCT01091376

Contacts
Contact: Shenglin Ma, MD +8657188122568 mashenglin@medmail.com.cn
Contact: Yaping Xu, MD +8657188122082 xuyaping1207@gmail.com

Locations
China, Zhejiang
Zhejiang Cancer Hospital Recruiting
Hangzhou, Zhejiang, China, 310022
Contact: Shenglin Ma, MD    +8657188122568    mashenglin@medmail.com.cn   
Contact: Yaping Xu, MD    +8657188122082    xuyaping1207@gmail.com   
Principal Investigator: Shenglin Ma, MD         
Sub-Investigator: Yaping Xu, MD         
Sponsors and Collaborators
Zhejiang Cancer Hospital
Investigators
Principal Investigator: Shenglin Ma, MD Zhejiang Cancer Hospital
Principal Investigator: Lvhua Wang, MD Chinese Academy of Medical Sciences
  More Information

No publications provided

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

Keywords provided by Zhejiang Cancer Hospital:
Non-small cell lung cancer
EGFR-TKI
Erlotinib
Radiotherapy

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Erlotinib
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014