S0350 Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage II, Stage III, or Stage IV Peripheral T-Cell Non-Hodgkin's Lymphoma

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT00109928
First received: May 3, 2005
Last updated: September 18, 2014
Last verified: September 2014
Results First Received: June 11, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Lymphoma
Interventions: Drug: cisplatin
Drug: etoposide
Drug: gemcitabine
Drug: methylprednisolone

  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
PEGS Patients received IV cisplatin 25 mg/m2 days 1–4, etoposide 40 mg/m2 days 1–4, gemcitabine 1000 mg/m2 day 1 and solumedrol 250 mg days 1–4 of a 21 day cycle for 6 cycles.

Participant Flow:   Overall Study
    PEGS  
STARTED     34  
Eligible     33  
Eligible and Began Protocol Therapy     33  
COMPLETED     21  
NOT COMPLETED     13  
Adverse Event                 2  
Progression                 6  
Death                 2  
not protocol specified                 2  
not eligible                 1  



  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.
Peripheral T-cell lymphomas (PTCLs) with stage II bulky, III or IV with extra-nodal, nodal and transformed cutaneous presentations were eligible.

Reporting Groups
  Description
PEGS Patients received IV cisplatin 25 mg/m2 days 1–4, etoposide 40 mg/m2 days 1–4, gemcitabine 1000 mg/m2 day 1 and solumedrol 250 mg days 1–4 of a 21 day cycle for 6 cycles.

Baseline Measures
    PEGS  
Number of Participants  
[units: participants]
  33  
Age  
[units: years]
Median ( Full Range )
  60  
  ( 20 to 92 )  
Gender  
[units: participants]
 
Female     11  
Male     22  
Ethnicity (NIH/OMB)  
[units: participants]
 
Hispanic or Latino     2  
Not Hispanic or Latino     31  
Unknown or Not Reported     0  
Race (NIH/OMB)  
[units: participants]
 
American Indian or Alaska Native     0  
Asian     1  
Native Hawaiian or Other Pacific Islander     0  
Black or African American     4  
White     28  
More than one race     0  
Unknown or Not Reported     0  



  Outcome Measures
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1.  Primary:   2-year Overall Survival Rate   [ Time Frame: 0-2 years ]

2.  Secondary:   2-year Progression-free Survival Rate   [ Time Frame: 0-2 years ]

3.  Secondary:   Response Rate   [ Time Frame: up to 3 years or time of disease progression ]

4.  Secondary:   Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug   [ Time Frame: up to 18 weeks of protocol treatment ]


  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: Study Statistician
Organization: SWOG Statistical Center
phone: 206-667-4623


Publications of Results:

Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT00109928     History of Changes
Other Study ID Numbers: CDR0000425643, S0350, U10CA032102
Study First Received: May 3, 2005
Results First Received: June 11, 2014
Last Updated: September 18, 2014
Health Authority: United States: Federal Government