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Prophylactic Cranial Irradiation in Erlotinib/Gefitinib-responders With Non-small Cell Lung Cancer (NSCLC) (RT1001)

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 July 2010 by Zhejiang Cancer Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01158170
First Posted: July 8, 2010
Last Update Posted: July 8, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Zhejiang Cancer Hospital
  Purpose

RATIONALE: Radiation therapy to the brain may be effective in preventing brain metastases in patients with advanced non-small cell lung cancer. It is not yet known whether radiation therapy is more effective than observation in patients with advanced non-small cell lung cancer.

PURPOSE: This randomized phase III trial is studying radiation therapy to the brain to see how well it works compared with observation in preventing brain metastases in patients with advanced non-small cell lung cancer


Condition Intervention Phase
Non-small Cell Lung Cancer Radiation: Prophylactic cranial irradiation Drug: Erlotinib /Gefitinib Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Randomized, Phase III Trial of Prophylactic Cranial Irradiation (PCI) in Patients With Advanced Non-small Cell Lung Cancer (NSCLC) Who Are Effective on Erlotinib or Gefitinib(RT1001)

Resource links provided by NLM:


Further study details as provided by Zhejiang Cancer Hospital:

Primary Outcome Measures:
  • The primary endpoint is the cumulative incidence of symptomatic brain metastases (BM) [ Time Frame: 2.5years ]

Secondary Outcome Measures:
  • overall survival [ Time Frame: baseline to date of death from any cause ]

Estimated Enrollment: 200
Study Start Date: June 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: prophylactic cranial irradiation
Patients receive Erlotinib or gefitinib until disease progression or intolerable toxicity, and prophylactic cranial irradiation 25GY over 10 fractions.
Radiation: Prophylactic cranial irradiation
25GY/10fraction
Other Name: PCI
Drug: Erlotinib /Gefitinib
Erlotinib 150mg/d or Gefitinib 250mg/d until disease progression or intolerable toxicity
Other Name: EGFR-TKI
Active Comparator: Conctrol
Patients received Erlotinib or gefitinib until disease progression,or intolerable toxicity
Drug: Erlotinib /Gefitinib
Erlotinib 150mg/d or Gefitinib 250mg/d until disease progression or intolerable toxicity
Other Name: EGFR-TKI

Detailed Description:

OBJECTIVES:

Primary

Determine the effectiveness of prophylactic cranial radiotherapy in patients with advanced non-small cell lung cancer that is responsive to gefitinib or erlotinib hydrochloride.

Secondary

Determine the progression-free survival in patients treated with this regimen. Determine the overall survival in patients treated with this regimen. Determine the safety and tolerability of this regimen in these patients. Determine the psycho-neurological effects of this regimen in these patients. Determine the quality of life of patients treated with this regimen. OUTLINE: This is a multicenter study. Patients with good response( CR/PR) to EGFR-TKI(Erlotinib or Gefitinib) are randomized to receive EGFR-TKI plus PCI or EGFR-TKI alone,stratified according to prior chemotherapy regimens (first line vs second line), and disease response status.

Group 1: Patients undergo prophylactic brain radiotherapy. Group 2: Patients undergo observation. Patients complete quality of life questionnaires periodically.

After completion of study therapy, patients are followed up periodically.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients were required to have histologically or cytologically documented
  2. NSCLC and no brain metastasis documented by magnetic resonance imaging (MRI)within 21 days after confirmed response (RR+SD) to chemotherapy
  3. No previous history of radiotherapy and surgery of brain
  4. good response( CR/PR) to Erlotinib or Gefitinib.
  5. Agree to radiotherapy
  6. age > 18 and <75 years,ECOG performance status 1 or less
  7. Good renal and hepatic and haematological (absolute neutrophils count 15 x1O9/L and platelet count 90 x 109/L,HB>=80g /DL) functions
  8. Have provided informed consent

Exclusion Criteria:

  1. Seizure cannot be controled by the drugs
  2. Combined with other disease of the brain such as tumour or infarction
  3. Hypersensitivity to MR enhancer -
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01158170


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: XuYa ping, MD    0086-571-88122082    xuyaping1207@gmail.com   
Zhejiang Cancer Hospital Recruiting
Hangzhou, Zhejiang, China
Contact: Shenglin MA, MD    +8657188122568    mashenglin@medmail.com.cn   
Contact: Yaping Xu, MD    +8657188122082    xuyaping1207@gmail.com   
Sponsors and Collaborators
Zhejiang Cancer Hospital
Investigators
Principal Investigator: Shenglin Ma, MD Zhejiang Cancer Hospital
  More Information

Responsible Party: Shenglin Ma, Zhejiang Cancer Hospital
ClinicalTrials.gov Identifier: NCT01158170     History of Changes
Other Study ID Numbers: ZhejiangCH06
First Submitted: June 23, 2010
First Posted: July 8, 2010
Last Update Posted: July 8, 2010
Last Verified: July 2010

Keywords provided by Zhejiang Cancer Hospital:
nonsmall cell lung cancer
brain metastasis
prophylactic cranial irradiation

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