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Trial record 1 of 1 for:    NCT00614484
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Chemotherapy and Proton Radiation for the Treatment of Locally Advanced Lung Cancer

This study has been terminated.
(Low participant enrollment rates. Significant comparative data not obtained.)
Sponsor:
Information provided by (Responsible Party):
Loma Linda University
ClinicalTrials.gov Identifier:
NCT00614484
First received: December 26, 2007
Last updated: April 28, 2014
Last verified: April 2014
Results First Received: July 16, 2013  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Locally Advanced Non-Small Cell Lung Cancer
Interventions: Radiation: Proton Radiation Therapy
Drug: Taxol
Drug: Carboplatin

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subject were recruited from the radiation oncology clinic from 11/99 through 4/11.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Treatment With Chemotherapy and Proton Beam Radiotherapy. Induction chemotherapy with two cycles of taxol and carboplatin given on day 1 and day 15. A five week coarse of proton radiotherapy begins on day 28 and is given once daily for the first two weeks and twice daily for the final 3 weeks. Weekly chemotherapy with carboplatin and taxol is given during proton therapy.

Participant Flow:   Overall Study
    Treatment With Chemotherapy and Proton Beam Radiotherapy.
STARTED   28 
COMPLETED   28 
NOT COMPLETED   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
28 subjects were enrolled and received the study treatment. All 28 were followed for treatment outcomes.

Reporting Groups
  Description
Treatment With Chemotherapy and Proton Beam Radiotherapy. Induction chemotherapy with two cycles of taxol and carboplatin given on day 1 and day 15. A five week coarse of proton radiotherapy begins on day 28 and is given once daily for the first two weeks and twice daily for the final 3 weeks. Weekly chemotherapy with carboplatin and taxol is given during proton therapy.

Baseline Measures
   Treatment With Chemotherapy and Proton Beam Radiotherapy. 
Overall Participants Analyzed 
[Units: Participants]
 28 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   13 
>=65 years   15 
Age 
[Units: Years]
Mean (Standard Deviation)
 66  (8) 
Gender 
[Units: Participants]
 
Female   11 
Male   17 
Region of Enrollment 
[Units: Participants]
 
United States   28 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Overall Survival.   [ Time Frame: Monthly for duration of participant lifespan. Average lifespan 1-2 years ]

2.  Secondary:   Treatment Related Toxicities.   [ Time Frame: Monthly for duration of participant lifespan. Average lifespan 1-2 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Slow enrollment over a long time period limits the conclusions that can be drawn.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: David Bush MD
Organization: Professor of Radiation Medicine, Loma Linda University Medical Center
phone: 909-558-4280
e-mail: dbush@llu.edu



Responsible Party: Loma Linda University
ClinicalTrials.gov Identifier: NCT00614484     History of Changes
Other Study ID Numbers: OSR #49168
Study First Received: December 26, 2007
Results First Received: July 16, 2013
Last Updated: April 28, 2014