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A Study of Pemetrexed Plus Carboplatin Combined With Radiation in Patients With Inoperable Locally Advanced Non-small Cell Lung Cancer (LA-NSCLC) (RT0801) (NSCLC)

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ClinicalTrials.gov Identifier: NCT00886678
Recruitment Status : Unknown
Verified March 2010 by Zhejiang Cancer Hospital.
Recruitment status was:  Active, not recruiting
First Posted : April 23, 2009
Last Update Posted : February 24, 2011
Sponsor:
Information provided by:
Zhejiang Cancer Hospital

Tracking Information
First Submitted Date  ICMJE March 31, 2009
First Posted Date  ICMJE April 23, 2009
Last Update Posted Date February 24, 2011
Study Start Date  ICMJE July 2008
Estimated Primary Completion Date July 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 21, 2010)
tumor response rate [ Time Frame: Tumor assessments after completion of chemoradiotherapy and every 2 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: April 22, 2009)
tumor response rate [ Time Frame: baseline to measured progressive disease ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 22, 2009)
  • overall survival [ Time Frame: baseline to date of death from any cause ]
  • time to progressive disease [ Time Frame: baseline to measured progressive disease ]
  • the safety profile [ Time Frame: every cycle ]
  • site of first failure in patients who develop progressive disease [ Time Frame: baseline to measured progressive disease ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Pemetrexed Plus Carboplatin Combined With Radiation in Patients With Inoperable Locally Advanced Non-small Cell Lung Cancer (LA-NSCLC) (RT0801)
Official Title  ICMJE A Phase II Study of Pemetrexed Plus Carboplatin Combined With Radiation in Patients With Inoperable Locally Advanced Non-small Cell Lung Cancer
Brief Summary Patients with inoperable Non-Small-Cell Lung Cancer will receive thoracic radiation therapy 66 Gy over 33 fractions,and concurrent with 2 cycles of chemotherapy with pemetrexed (500 mg/m2,d1,repeated every 3 weeks)and carboplatin (AUC=5,d1,repeated every 3 weeks).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Non-Small Cell Lung Cancer
Intervention  ICMJE
  • Drug: pemetrexed
    500 mg/m2, IV, q 21 days x 2 cycles
  • Drug: carboplatin
    AUC=5,IV,q 21 days x 2 cycles
  • Radiation: thoracic radiation
    66 Gy over 33 fractions
Study Arms  ICMJE Experimental: 1
patients receiving pemetrexed, carboplatin and radiation therapy.
Interventions:
  • Drug: pemetrexed
  • Drug: carboplatin
  • Radiation: thoracic radiation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: April 22, 2009)
63
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2010
Estimated Primary Completion Date July 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histologically proven non-small cell lung cancer (non-squamous cell carcinoma)
  • Presence of measurable disease by RECIST
  • Inoperable stage IIIA or IIIB
  • ECOG performance status 0-1
  • 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 within the last five years except cured basal cell carcinoma of skin and cured carcinoma in-situ of uterine cervix Any other morbidity or situation with contraindication for chemotherapy (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 14 days before the first administration) and pregnant women
  • Women and men of childbearing potential who have no willing of employing adequate contraception
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00886678
Other Study ID Numbers  ICMJE ZhejiangCH01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ma Shenglin, Xu Yaping, Zhejiang Cancer Hospital
Study Sponsor  ICMJE Zhejiang Cancer Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ma Sheng lin, MD Zhejiang Cancer Hospital
PRS Account Zhejiang Cancer Hospital
Verification Date March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP