Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

S0220: Chemoradiotherapy Followed By Surgery and Docetaxel in Treating Patients With Pancoast Tumors

This study has been completed.
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Eastern Cooperative Oncology Group
American College of Surgeons
North Central Cancer Treatment Group
NCIC Clinical Trials Group
Cancer and Leukemia Group B
Information provided by (Responsible Party):
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT00062439
First received: June 5, 2003
Last updated: October 30, 2013
Last verified: October 2013
Results First Received: November 15, 2012  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Lung Cancer
Interventions: Drug: cisplatin
Drug: docetaxel
Drug: etoposide
Procedure: conventional surgery
Radiation: radiation therapy

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Induction Cisplatin/Etoposide + XRT/Surgery/Consolidation Chem Patients were given induction therapy consisting of concurrent cisplatin + etoposide + 45 Gy thoracic radiation given in 25 daily fractions, followed by thoracotomy, followed by consolidation chemotherapy consisting of three cycles of docetaxel.

Participant Flow for 4 periods

Period 1:   Induction Chemotherapy + Radiotherapy
    Induction Cisplatin/Etoposide + XRT/Surgery/Consolidation Chem
STARTED   46 
COMPLETED   38 
NOT COMPLETED   8 
Ineligible                1 
Refused protocol treatment                1 
Adverse Event                3 
Lack of Efficacy                3 

Period 2:   Post Chemoradiation Assessment
    Induction Cisplatin/Etoposide + XRT/Surgery/Consolidation Chem
STARTED   38 
COMPLETED   29 
NOT COMPLETED   9 
Death                1 
Disease progression                2 
Withdrawal by Subject                1 
Physician Decision                1 
Not eligible to continue to surgery                4 

Period 3:   Surgery
    Induction Cisplatin/Etoposide + XRT/Surgery/Consolidation Chem
STARTED   29 
COMPLETED   22 
NOT COMPLETED   7 
Physician Decision                4 
Death                1 
Adverse Event                2 

Period 4:   Consolidation Chemotherapy
    Induction Cisplatin/Etoposide + XRT/Surgery/Consolidation Chem
STARTED   22 
COMPLETED   20 
NOT COMPLETED   2 
Adverse Event                2 



  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.
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Reporting Groups
  Description
Induction Cisplatin/Etoposide + XRT/Surgery/Consolidation Chem Patients were given induction therapy consisting of concurrent cisplatin + etoposide + 45 Gy thoracic radiation given in 25 daily fractions, followed by thoracotomy, followed by consolidation chemotherapy consisting of three cycles of docetaxel.

Baseline Measures
   Induction Cisplatin/Etoposide + XRT/Surgery/Consolidation Chem 
Overall Participants Analyzed 
[Units: Participants]
 44 
Age 
[Units: Years]
Median (Full Range)
 59 
 (44 to 75) 
Gender 
[Units: Participants]
 
Female   12 
Male   32 
Race (NIH/OMB) 
[Units: Participants]
 
American Indian or Alaska Native   1 
Asian   3 
Native Hawaiian or Other Pacific Islander   0 
Black or African American   0 
White   40 
More than one race   0 
Unknown or Not Reported   0 


  Outcome Measures
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1.  Primary:   Feasibility of Treating Patients With Stage IIB/IIIB Pancoast Tumors With a Regimen of Cisplatin and Etoposide Plus Concurrent Radiotherapy Followed by Surgical Resection Followed by Consolidation Therapy With Docetaxel.   [ Time Frame: After completion of 5 weeks of radiotherapy given concurrently with cisplatin+etoposide, surgery + 8 weeks of recovery time, and 6 weeks of consolidation therapy with docetaxel ]

2.  Secondary:   Adverse Events   [ Time Frame: Weekly for the first 13 weeks, then every 3 weeks for the next 6 weeks. ]

3.  Secondary:   Overall Survival   [ Time Frame: daily for 12 weeks then every 3 weeks for 12 weeks, then every 6 months thereafter. ]

4.  Secondary:   Progression-Free Survival at 3 Years   [ Time Frame: At the completion of induction therapy, then again 4 weeks after the completion of consolidation therapy, then every 3 months for 2 years, then every 6 months until up to a maximum of 5 years after enrollment. ]

5.  Secondary:   Response   [ Time Frame: After completion of induction therapy. ]


  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
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Lung Committee Statistician
Organization: SWOG Statistical Center
phone: 206-667-4623



Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT00062439     History of Changes
Other Study ID Numbers: CDR0000304777
U10CA032102 ( US NIH Grant/Contract Award Number )
S0220 ( Other Identifier: SWOG )
Study First Received: June 5, 2003
Results First Received: November 15, 2012
Last Updated: October 30, 2013
Health Authority: United States: Federal Government