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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

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ClinicalTrials.gov Identifier: NCT00614484
Recruitment Status : Terminated (Low participant enrollment rates. Significant comparative data not obtained.)
First Posted : February 13, 2008
Results First Posted : May 22, 2014
Last Update Posted : May 22, 2014
Sponsor:
Information provided by (Responsible Party):
Loma Linda University

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
Enrollment 28
Recruitment Details Subject were recruited from the radiation oncology clinic from 11/99 through 4/11.
Pre-assignment Details  
Arm/Group Title Treatment With Chemotherapy and Proton Beam Radiotherapy.
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 28
Completed 28
Not Completed 0
Arm/Group Title Treatment With Chemotherapy and Proton Beam Radiotherapy.
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 28
Hide Baseline Analysis Population Description
28 subjects were enrolled and received the study treatment. All 28 were followed for treatment outcomes.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants
<=18 years
0
   0.0%
Between 18 and 65 years
13
  46.4%
>=65 years
15
  53.6%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 28 participants
66  (8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants
Female
11
  39.3%
Male
17
  60.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 28 participants
28
1.Primary Outcome
Title Overall Survival.
Hide Description Median survival time following treatment.
Time Frame Monthly for duration of participant lifespan. Average lifespan 1-2 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Chemothrapy and Proton Therapy
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 28
Median (95% Confidence Interval)
Unit of Measure: Months
15
(10 to 20)
2.Secondary Outcome
Title Treatment Related Toxicities.
Hide Description

grade 3 or higher esophageal toxicity

Toxicity is categorized either early or late phase.

Early phase- toxicity occurring during or within 30 days s/p treatment Late phase- toxicity occurring thereafter

Time Frame Monthly for duration of participant lifespan. Average lifespan 1-2 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Chemotherapy and Proton Therapy
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 28
Measure Type: Number
Unit of Measure: participants
2
Time Frame Participants were followed for the duration of their lifespan, an average of 1-2 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment With Chemotherapy and Proton Beam Radiotherapy.
Hide Arm/Group Description 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.
All-Cause Mortality
Treatment With Chemotherapy and Proton Beam Radiotherapy.
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Treatment With Chemotherapy and Proton Beam Radiotherapy.
Affected / at Risk (%) # Events
Total   4/28 (14.29%)    
Respiratory, thoracic and mediastinal disorders   
Pneumonitis  [1]  2/28 (7.14%)  2
Pulmonary hemorrage   1/28 (3.57%)  1
Esophageal Fistula   1/28 (3.57%)  1
Indicates events were collected by systematic assessment
[1]
Grade 3 pneumonitis
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Treatment With Chemotherapy and Proton Beam Radiotherapy.
Affected / at Risk (%) # Events
Total   12/28 (42.86%)    
Respiratory, thoracic and mediastinal disorders   
Esophagitis  [1]  12/28 (42.86%)  12
Indicates events were collected by systematic assessment
[1]
Grade 1/2 esophagitis
Slow enrollment over a long time period limits the conclusions that can be drawn.
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
EMail: dbush@llu.edu
Responsible Party: Loma Linda University
ClinicalTrials.gov Identifier: NCT00614484     History of Changes
Other Study ID Numbers: OSR #49168
First Submitted: December 26, 2007
First Posted: February 13, 2008
Results First Submitted: July 16, 2013
Results First Posted: May 22, 2014
Last Update Posted: May 22, 2014